Psychoeducation/Psychoeducational Interventions

STUDY PURPOSE: To evaluate the effectiveness of educational interventions for managing fatigue in adults with cancer

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 14 studies  
• TOTAL PATIENTS INCLUDED IN REVIEW = 2,213
• SAMPLE RANGE ACROSS STUDIES: 30–396
• KEY SAMPLE CHARACTERISTICS: Multiple different types of cancer at various phases of care. Most had mild to moderate fatigue at baseline.

PHASE OF CARE: Multiple phases of care

• For general fatigue: SMD = –0.27 (95% confidence interval [CI] [–0.51, –0.04]), showing a positive effect of education. These studies were of low quality.
• For fatigue intensity: SMD = –0.28 (95% CI [–0.51, –0.04]) effect of education. These studies were of moderate quality.
• For fatigue interference: SMD = –0.35 (95% CI [–0.54, –0.16]), showing benefit of education. Studies were of moderate quality.
• For anxiety (three studies): SMD = –1.37 (95% [CI –2.76, –0.18]). Studies were of low quality.
• For depression (four studies of very low quality), no impact on depression was found.
• Insufficient evidence existed to analyze the results according to stage of disease, phase of care, and method of education delivery. Education was delivered individually, face-to-face, in group settings, or with self-use of video or print material. Most interventions included counseling and patient training components.

Educational interventions appear to play some role in reducing overall fatigue, fatigue intensity, and fatigue interference, and might provide some benefit for anxiety. No effect on depression was found in this study, but baseline levels of depression were not generally clinically relevant.

• High heterogeneity

The incorporation of educational interventions as part of care to manage fatigue is reasonable but may not be sufficient to have a clinically meaningful impact.

• FINAL NUMBER STUDIES INCLUDED = 10 
• TOTAL PATIENTS INCLUDED IN REVIEW = 2,534
• SAMPLE RANGE ACROSS STUDIES: 30–282 patients
• KEY SAMPLE CHARACTERISTICS: Multiple types of cancer were represented across studies.

Interventions included exercise in eight studies, sleep hygiene in seven, relaxation training in six, and nutritional guidance in six. Six studies included the use of a booklet as supplement material. Four studies included telephone follow-up, and one was provided via an Internet-based program. The program duration ranged from 1 week to 12 weeks. Attrition rates ranged from 7%–46.7%. Two studies demonstrated significant reduction of fatigue with ES ranging from –0.76 to –1.41 (p < 0.001). Six studies concluded achieving a limited positive effect, with a small effect size and no statistical significance. One study showed no effect, and one showed worse outcomes in the intervention group. High heterogeneity existed across trials, so no meta-analysis was deemed appropriate.

Inconsistent evidence of effects of patient education programs on cancer-related fatigue existed across all 10 studies.

• Variability of cancer types, stages, treatments, and phases of care across studies
• Various types of control conditions could contribute to bias.
• Variability existed in program duration, methods of delivery, and follow-ups.
• High attrition existed in some studies.
• Many studies included exercise, which alone has been shown to be of benefit for fatigue.

Some mixed evidence exists regarding the effects of patient education programs on cancer-related fatigue, which are related to the variability in interventions that have been studied. More rigorous research is needed to sort out those program characteristics and populations of patients who can benefit most from educational interventions.

STUDY PURPOSE: To examine the effects of behavioral techniques (e.g., behavioral therapy, cognitive therapy, mind-body and relaxation techniques, counseling, social support, hypnosis, biofeedback, exercise, physical exercise (PhysEx), aerobic exercise, physical activity, motor activity) on psychosocial functioning outcome measures, such as fatigue, depression, anxiety, body image, and stress, and on health-related quality of life

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED =  56 studies: 39 studies of behavioral techniques; 14 studies of physical exercise; 3 studies of both 
• TOTAL PATIENTS INCLUDED IN REVIEW = Not reported. This meta-analysis reported the number of patients by each randomized, controlled trial: 5,462 (behavioral intervention patients), 1,457 (PhysEx patients), 6,919 (total)
• SAMPLE RANGE ACROSS STUDIES: 28–558 (behavioral intervention), 22–242 (PhysEx)
• KEY SAMPLE CHARACTERISTICS: 33 studies of patients with nonmetastatic cancer, 4 studies of patients with metastatic cancer, 5 studies with a mix of patients

PHASE OF CARE: Multiple phases of care
 
APPLICATIONS: Elder care, palliative care

Behavioral techniques affect specific aspects of psychosocial functioning but have a minor, insignificant effect on health-related quality of life. PhysEx has a positive effect on health-related quality of life. Behavioral techniques demonstrated a moderately significant effect on anxiety and depression and showed a significant but small effect on fatigue. PhysEx was effective for fatigue and showed a positive effect for depression.

• No quality evaluation
• High heterogeneity
• The variety of behavioral interventions made it challenging to select which was more effective than others (e.g., telephone counseling, telephone support, education, body-mind social support self-help, therapeutic groups by telephone, nurse self-efficacy).
• Studies were included only through 2008—more recent evidence has shown some different findings.
• High heterogeneity in behavioral technique analysis
• The studies used a wide range of different measurements and interventions.

A range of behavioral techniques may be effective for patients with breast cancer and fatigue, depression, and depressed body image. PhysEx was shown to improve health-related quality of life, fatigue, anxiety, and depression. Recognizing the symptoms of patients with breast cancer was emphasized as having positive effects (e.g., feeling relieved, hearing helpful strategies addressing quality of life and psychosocial problems).

To evaluate if psychosocial interventions are effective in reducing fatigue and to consider which interventions are the most effective.

Databases searched were Cochrane Central Register, PUBMED, MEDLINE, EMBASE, CINAHL, and PsycINFO to September 2008. Hand searching of reference lists was also performed.

Extensive keywords and specific search terms per database were provided.

Studies were included in the review if 

• They reported adult participants receiving active curative or palliative treatment
• The intervention involved a systematic intervention consisting of a process between the patient and the provider
• The intervention included at least two contacts between the patient and provider and, during the intervention, the provider gave the patient some type of individual feedback
• Fatigue was at least one of the outcome measures
• They were randomized, controlled trials.

Patients were excluded if they were breast cancer survivors receiving only hormonal therapy and were not considered in active treatment.

In total, 85 references were retrieved. The Jadad scale criteria were applied for quality rating, as well as additional criteria identified by vanTulder (1997).

• The final number of studies included was 27; seven studies (n = 969) were aimed specifically at fatigue.
• The sample range across the studies was 60 to 396 patients.
• All patients were receiving various active treatment types.
• Various diagnoses were involved, but the majority of studies were performed on women with breast cancer.

• Patients were undergoing multiple phases of care.
• The study has clinical applicability for palliative care.

In most studies, it was unclear at what stage of cancer the intervention ended. In most studies, the interventions were given by nurses. Formats varied and included intervention in groups; combination of face-to-face and telephonic support; and provision of additional written, videotape, or audiotape information. The number and duration of sessions varied across studies. In four studies, participants received an intervention of the same number and duration for the attention control. The number, type, and timing of outcome assessments also varied. Most studies used one instrument to measure fatigue, with the Profile of Mood States (POMS) used most often. Only five studies used a measure specifically defined to measure fatigue. Only three studies scored at least a three on the Jadad quality scale, and only one study had a good evaluation of quality scoring related to internal validity. Most had a moderate quality. Seven studies reported a significant effect on fatigue, with effect sizes ranging from 0.17 to 1.07 (p ≤ 0.05). In two of these, there was an immediate effect, but the results were not maintained at follow-up. Twenty studies were regarded as not effective. Interventions specifically aimed at fatigue, rather than multiple additional symptoms, tended to be more effective for fatigue.

Findings showed that there was no solid evidence that interventions not specifically focused on fatigue were effective in reducing fatigue. Overall, there was limited support and conflicting results for psychosocial interventions on fatigue during cancer treatment. Studies that showed an effect included education about fatigue and teaching in self-care or coping strategies and taught activity management, balancing activity, and rest.

• Only studies involving patients during active treatment were included, so the findings may not apply to other patient groups.
• There were indications that prevalence and course of fatigue may depend on the type of treatment received.
• Heterogeneity among studies in these factors limited the ability to draw firm conclusions regarding the effectiveness of various interventions.

Psychoeducational interventions, including education about fatigue, helping patients in self-care and coping, and teaching patients to balance activity and rest, may be helpful in alleviating fatigue among patients receiving cancer treatment. The degree and timing of fatigue can vary according to treatment type and the cancer trajectory. The most effective interventions based on treatment and phase of care were not clear, and further research in this area is warranted.

• PHASE OF CARE: Multiple phases of care 
• APPLICATIONS: Pediatrics

Guidelines and algorithm developed

• Limited data reviewed.
• Guidelines based on data from 2009
• Implementation and evaluation plans for translation to practice not described

Guidelines developed for clinical practice.

STUDY PURPOSE: To review the published evidence on non-pharmacologic interventions for fatigue in men with prostate cancer

TYPE OF STUDY: Meta-analysis and systematic review

DATABASES USED: PubMed, PsycINFO, CINAHL, Cochrane Central Trials Register and Embase, PsychExtra, SIGLE, Australian New Zealand Clinical Trials Registry, ClinicalTrials.gov, World Health Organisation International Clinical Trials Registry Platform, EU Clinical Trials Register, MedNar, and reference lists of articles included in review

KEYWORDS: key concepts of prostate cancer, fatigue, non-pharmacological and nursing management, and various interventions; detailed search for PubMed included as appendix

INCLUSION CRITERIA: Adult men older than 18 years with prostate cancer at any stage of treatment; non-pharmacologic interventions including exercise, exercise with diet and lifestyle modification, education, and cognitive behavioral therapy; comparison to other non-pharmacologic interventions or usual care; experimental studies; fatigue as primary outcome of interest using existing validated tools to measure

EXCLUSION CRITERIA: Not stated

TOTAL REFERENCES RETRIEVED = 1,480

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two independent reviewers appraised studies; validity assessed with Johanna Briggs Institute Critical Appraisal Checklist for Randomised and Pseudo-Randomised Studies

• FINAL NUMBER STUDIES INCLUDED = 8
• SAMPLE RANGE ACROSS STUDIES: 21–240
• TOTAL PATIENTS INCLUDED IN REVIEW = 600
• KEY SAMPLE CHARACTERISTICS: Undergoing treatment for prostate cancer or completed treatment within past 12 months; age range 46–86 years

PHASE OF CARE: Multiple phases of care     

APPLICATIONS: Elder care

All studies were of high methodologic quality. Four out of five studies measuring physical activity found statistically significant fatigue reduction; the other study showed a trend toward fatigue reduction. Two studies concluded that cognitive behavioral therapy was effective in managing cancer-related fatigue. Two studies looking at education had mixed results. Brief nursing education was not significant in reducing fatigue, but intensive prostate-specific education was significant.

This report supports physical activity for managing cancer-related fatigue. Cognitive behavioral therapy and intensive focused education are also likely to be effective.

• Only eight studies included
• Variety in delivery of interventions and measurement of fatigue

Nurses should continue to recommend physical activity for management of cancer-related fatigue. Cognitive behavioral therapy and intensive education may be considered.

Participants were offered the Nucare coping strategies program (teaches people to cope with cancer, based on the McGill Model of Nursing) in one of three formats:  small group; one on one; and one on one with therapy (home version with materials).  There was no control arm.  Data were taken at baseline and two and three months following the intervention outcome.  Participants chose the study arm.

• Fifty-nine participants completed the study, and there were outcomes data for 50.
• Gender, race, and income were not described. 
• Participants had head and neck cancer.

This was a nonrandomized, no control pilot, feasibility study for delivery in which participants wanted the intervention.

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)

Fatigue was improved in 17 (38%) patients overall, and improvement was equal in self (home) to that seen with the use of a therapist.

• Only one cancer group was studied.
• There were costs associated with the use of a therapist.

To evaluate the efficacy of the psychoeducational program in alleviating cancer-related fatigue and mood symptoms, and improving quality of life among breast cancer survivors

• N = 40 for the intervention group, 40 for the control group (waiting control)   
• AGE = 42.1 years (9.7) for the intervention, 41.8 years (10.3) for the control group
• FEMALES: 100%
• CURRENT TREATMENT: Radiation 
• KEY DISEASE CHARACTERISTICS: Breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Nonmetastatic breast cancer, stages 1 and 2, Karnofsky Performance Scale (KPS) scores of 70 and more

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: At the outpatient clinic in the Department of Clinical Oncology in the Faculty of Medicine, Cairo University, Egypt

• PHASE OF CARE: Transition phase after active treatment
• APPLICATIONS: Palliative care 

Case control study

• Multidimensional Fatigue Inventory SF-36 (MFI SF-36) 
• Hospital Anxiety and Depression Scale (HADS)

The four-week psychoeducational program improved fatigue and quality of life after radiation therapy in patients with breast cancer.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)
• Selective outcomes reporting
• Intervention expensive, impractical, or training needs
• Questionable protocol fidelity

The intervention may be taught by trained nurses and can be part of a routine supportive care at very low additional costs for healthcare systems.

Patients were randomized to two intervention groups:  Individual Psychosocial Support, provided by a trained oncology nurse (INS), and Individual Psychosocial Support, provided by a psychologist (IPS). Both interventions used the same techniques of relaxation, distraction, activity scheduling, and ways to improve communication. The number of sessions and time intervals between sessions varied according to the needs and desires of individual patients. Each session lasted 45 to 60 minutes, in which patients' problems were identified and developments were made to help manage these problems. Patients were provided with written and oral instructions on how to practice these strategies. Quality of life questionnaires were administered at baseline and at one, three, and six months.

• The study included 179 women with breast cancer about to start adjuvant treatment.
• Mean age was 55 years (range 23–87).
• Of the participants, 136 were married/cohabitant, and the majority (n = 130) were in stage T1.
• Most participants had received no preoperative chemotherapy.
• For postoperative treatment, most had received local radiation therapy only (n = 100), hormonal therapy (n = 88), or adjuvant polychemotherapy (n = 69).
• Patients were excluded if they had ongoing psychiatric illness, previous cancer diagnosis, or inability to speak and understand Swedish.

Department of Oncology, Uppsala University Hospital

Patients were undergoing the active treatment phase of care.

This was a prospective, randomized study.

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

Intervention groups had lower fatigue scores on the EORTC-QLQ-C30 at baseline, one month, and six months; these differences were minimal and not statistically significant.

• Twenty percent of the patients did not complete all three assessments.
• A significantly higher proportion of patients randomized to the INS group were diagnosed in stage N0 compared to the other groups. It is unclear whether this had a significant impact on the results.

To test the effectiveness of two telephone-delivered psychosocial interventions for maintaining and improving quality of life (QOL).

The first intervention was a telephone interpersonal counseling (TIP-C) intervention delivered weekly for eight weeks to prostate cancer survivors and every other week, for four times, to partners. The second intervention included eight weekly health education attention conditions (HEACs) delivered by telephone.

• Seventy-one survivors (100% male) and 70 partners (5.7% male, 94.2% female) were included.
• Mean age was 66.99 for survivors and 61.13 for partners.
• Patients were survivors of prostate cancer.

• Single site  
• Home
   

• Patients were undergoing the long-term follow-up phase of care.
• The study has clinical applicability for late effects and survivorship and elderly care.
   

The study used a repeated measures experimental design.

• Center for Epidemiologic Studies Depression Scale (CESD)    
• Positive and Negative Affect Schedule (PANAS)
• University of California, Los Angeles Prostate Cancer Index (UCLA PCI)
• Multidimensional Fatigue Inventory (MFI)
• Social Well-Being Scale
• Perceived Social Support–Family Scale (PSS–Fa)
• Quality of Life, Breast Cancer version–Spiritual Well-Being subscale 

Improvements in depression, negative affect, stress, fatigue, and spiritual well-being were significantly higher for survivors in the HEAC intervention than in the TIP-C intervention. Partners in the HEAC intervention showed significantly greater improvements in depression, fatigue, social support from family members, social well-being, and spiritual well-being compared to partners in the TIP-C intervention.

Both interventions were effective in improving multiple dimensions of QOL for men with prostate cancer and their partners.

The study had a small sample size, with less than 100 participants.

Both interventions were effective, but further research is needed.

Each of the three intervention programs included seven sessions. Group size varied from 3 to 10 participants. The physical training session lasted 60 minutes and consisted of light physical activity with movement and fitness training, relaxation, sitting, and breathing exercises. A booster session was held two months after the conclusion of training exercises. In the 60-minute information session, emphasis was placed on providing participants with information about prostate cancer, its treatment and side effects, and effective means to cope with side effects. Participants were encouraged to discuss their experiences and reactions regarding diagnosis and to communicate with group leaders and other participants. In the 135-minute information and physical training session, participants were given physical training and information in the same session. In the control, participants receiving standard care could telephone a nurse if they had questions. Questionnaire materials were obtained two weeks after inclusion into the study and at the six- and 12-month follow-ups.

• The study included 211 men diagnosed with prostate cancer within six months. 
• Mean age was 69 years (range 43–86).
• Twenty percent of participants had metastasis.
• The most common curative treatment was radical prostatectomy.
• Proportions of marriage (80%) and retirement (70%) were comparable among the groups.
• Participants were excluded if they had another cancer diagnosis, participated in other studies, were participants in other care programs, had hearing/vision impairment, were non-Swedish speaking, or were physically or mentally disabled.

University hospital in Uppsala, Sweden, Regional Oncological Centre

Participants were undergoing the active treatment phase of care.

Participants were stratified and randomized to one of four groups:  physical training (n = 53), information (n = 55), information and physical training (n = 52), and the control group (n = 51).

European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30)

Participants with metastases scored less than participants without metastases on the fatigue subscale of the EORTC QLQ-C30 at baseline and at 12 months. No significant differences were observed between the psychosocial rehabilitation groups when compared to the no intervention group.

The lack of effect on outcome measures may be due to the low power and complicated design. Heterogeneity of the sample, despite stratification, may have led to an unbalanced distribution of participant clinical and demographic characteristics in each treatment group.

To evaluate the effects of a psychosocial support intervention on health-related quality of life (QOL) and fatigue.

Participants were randomized to an intervention or usual care control group. The intervention consisted of education sessions mixed with exercise, relaxation training, massage, qigong, visualization, and social activities, such as concerts and museum and restaurant visits. As reported in a previous pilot study, participants were residents at a spa-type facility during the intervention. The intervention was provided by an interdisciplinary group comprising physicians, psychologists, an art therapist, a massage therapist, a dietician, social workers, and a trained qigong provider for seven days. Follow-up was performed at two, six, and 12 months. Participants in the usual care control were only provided follow-up data collection.

• In total, 360 participants (100% female) were included.             
• Mean age was 58 years (range 30–84).
• All participants had breast cancer. Most had undergone breast-conserving surgery and had received or were receiving radiation therapy.
• Of the participants, 53% were married.

• Single site  
• Inpatient   
• Sweden

• Participants were undergoing the transition phase after active treatment.
• The study has clinical applicability for elderly care.

The study was a randomized, controlled trial.

• Swedish version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), including the 23-item breast cancer module
• Fatigue Questionnaire, Swedish version

Fatigue scores were similar in both groups and declined over time up to 12 months in both groups. There were no differences in fatigue levels over time between the groups. There were no significant effects of the intervention on QOL measures.

The multimodal intervention demonstrated no significant effect on QOL or fatigue.

• The study had risks of bias due to no blinding, no appropriate attentional control condition, and the sample characteristics.
• The findings were not generalizable.
• The intervention was expensive, impractical, and required training.
• Participants tended to self-select for involvement. 
• This type of week-long stay and set of interventions can be expected to be expensive.

The specific approach providing a multifaceted, psychoeducational type of intervention was not shown to affect fatigue or QOL in women with breast cancer. The most effective content, duration, and frequency of psychosocial and multimodal support interventions were not clear.

The intervention consisted of structured sessions that began with 20 minutes of conditioning exercises conducted by a physical therapist, followed by an educational session with cognitive-behavioral strategies for coping with cancer, and an open discussion with group leaders and other participants. Sessions were balanced with didactic material, a question and answer period, sharing, reflecting, relaxation, and physical activity. Participants attended eight sessions throughout the four weeks following enrollment. The intervention was delivered three days per week. After the fourth week, patients completed quality of life (QOL) questionnaires, and the questionnaires were collected at eight and 27 weeks after enrollment via mail.

• In total, 103 patients (66 male, 37 female) were included.
• Mean age was 59.6 years (range 31–85); 85.7% of patients were older than 50 years.
• The most common dominant disease status was gastrointestinal (36.7%).
• Of the participants, 59.2% were undergoing current chemotherapy, 77.6% were married, and 57.1% were currently employed.

Patients were included if they

• Were diagnosed within the past year
• Had an expected survival time of at least six months
• Had a treatment recommendation of radiation therapy of at least two weeks.

Patients were excluded if they had undergone previous radiation therapy, had recurrent disease after a disease-free period longer than 6 months, or had psychiatric disorders or active suicidality.

Division of Radiation Oncology, Mayo Clinic, Rochester, Minnesota

Patients were undergoing the active treatment phase of care.

The study was a randomized, stratified, two-group, controlled clinical trial and included a structured intervention arm (n = 49) and a standard medical care arm (n = 54).

• Linear Analogue Self Assessment (LASA)
• Profile of Mood States (POMS)
• Spielberger’s State-Trait Anxiety Inventory (STAI)
• Symptom Distress Scale (SDS)

The intervention had no significant impact on any fatigue measures between the groups. No significant differences were observed at baseline between the groups for fatigue. There were no significant differences in mean fatigue scores between the groups at any week.

The compliance of the patients after the sessions were completed is unknown.

Compare the effects of methylphenidate (MP) (psychostimulant) with those of a placebo (PL) on cancer-related fatigue. The effect of a combined intervention including MP plus a nursing telephone intervention (NTI) also was assessed.

Patients with a fatigue score of greater than or equal to 4 out of 10 on the Edmonton Symptom Assessment Scale (ESAS) randomly were assigned to one of the following four groups: MP plus NTI, PL plus NTI, MP plus control telephone intervention (CTI), and PL plus CTI.

• N = 141
• MEDIAN AGE = 58 years
• MALES: 33%, FEMALES: 67%
• KEY DISEASE CHARACTERISTICS: Diagnosis of advanced cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Four or above on the ESAS, normal score on the Mini Mental State Examination (MMSE), no severe comorbid conditions including severe anxiety, major depression, substance abuse, or erythropoietin use

• SITE: Multi-site  
• SETTING TYPE: Outpatient  
• LOCATION: Outpatient palliative care and oncology clinics at MD Anderson Cancer Center and at Lyndon B. Johnson General Hospital, both in Houston, TX

• PHASE OF CARE: Mutliple phases of care
• APPLICATIONS: Pediatrics, elder care, palliative care

Randomized, controlled trial; placebo controlled

• Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
• ESAS
• MMSE
• Hospital Anxiety and Depression Scale (HADS)
• Pittsburgh Sleep Quality Index (PSQI)

The groups MP alone, NTI alone, or MP plus NTI proved not significantly better than PL for cancer-related fatigue. Anxiety improved with the telephone intervention (p = .01), as did sleep (p < .001).

MP, used alone or in combination with NTI, was not superior to the control group or the PL for fatigue or depression. NTI was associated with improvement in anxiety and sleep.

• Risk of bias (no blinding)
• No statistical control for multiple comparisons, which could lead to a type one error
• Limited duration of two weeks  
• Content of CTI not described

Although the use of MP did not prove to be effective for cancer-related fatigue, several cancer-related symptoms significantly were improved with NTI. Further research in this area would be ideal, but NTIs remain potentially effective for patient support and education and can have a positive effect on patient experience.

To examine the effectiveness of a psychoeducational intervention (PEI) on the symptom cluster of anxiety, breathlessness, and fatigue compared with usual care.

Education on symptom management and coaching on the use of progressive muscle relaxation was delivered to patients one week prior to the start of radiotherapy (RT) and repeated three weeks after beginning RT. Symptom data were collected at four times points:  prior to the intervention and at three, six, and 12 weeks postintervention.

• In total, 140 patients (83% male, 17% female) with lung cancer receiving palliative RT were included.
• Patients were 16 years or older.
• Patients had stage III or IV lung cancer.

• Single site
• Outpatient
• RT unit of a publicly funded hospital in Hong Kong

The study was a randomized, controlled trial using a pre-/posttest design with two groups.

• Breathlessness was assessed using a 100-mm visual analog scale.
• Fatigue was measured with the intensity subscale of the revised Piper Fatigue Scale (PFS), consisting of 23 items. The instrument was translated into Chinese and found to be valid and reliable.
• Anxiety was measured using the Chinese version of the State-Trait Anxiety Inventory (STAI), consisting of 20 items for measuring immediate feelings of apprehension, nervousness, and worry.
• Functional ability was a secondary outcome measure, using the subscale of the Chinese version of the Short Form 36 (SF-36) Health Survey.

A significant difference (p = 0.003) was seen over time on the pattern of change of the symptom cluster between the PEI intervention and the usual care control group. Significant effects on patterns of changes in breathlessness (p = 0.002), fatigue (p = 0.011), anxiety (p = 0.001), and functional ability (p = 0.000) were found.

PEI is an effective treatment for relieving the symptom cluster of anxiety, breathlessness, and fatigue and each of the individually assessed symptoms.

• The study had a small sample size, with less than 100 participants.
• A high attrition rate was due to death.

The study provided evidence to support the symptom cluster of anxiety, breathlessness, and fatigue as interrelated, with assessment and management of those three symptoms as a cluster. Clarification of the nature of their interrelatedness is a potential area of further study. Education and counseling patients through nurses can be helpful in the management of these symptoms.

To determine the feasibility and efficacy of a physical activity (PA) behavioral change intervention on managing cancer-related fatigue among gynecological cancer survivors during and after anticancer treatments.  

After telephone screening and written informed consent, blinded baseline assessments were conducted prior to randomization via a computer-generated random numbers table. Participant randomization was stratified according to treatment status (i.e., currently in treatment versus posttreatment). The intervention included an initial personal consultation with a physiotherapist who educated patients about the benefits of PA and discussed behavioral change strategies. Weekly telephone calls were used to reinforce education, identify barriers to PA, and set activity goals. A final consultation was held to establish longer-term goals and review the program. The control group also received weekly telephone calls for the duration of the intervention in order to match the attention provided to the experimental group.

• In total, 33 participants (100% female) were included.    
• Age was 18 years or older.
• Participants had ovarian (n = 12) and endometrial (n = 11) tumors, and the remaining participants (n = 10) had uterine, cervical, and mixed gynecological tumors. Participants were diagnosed with gynecological cancer stage I to III, had completed surgery, and were currently undergoing treatment or were postanticancer treatment within three years of diagnosis (average of nine months postdiagnosis).
• Interested participants were screened for eligibility via the telephone.
• Participants reported mild to moderate fatigue (1–10 numeric rating scale) and were currently sedentary (vigorous PA less than 20 minutes/week or moderate PA less than 60 minutes/week, for the past six months).

• Single site  
• Northern Ireland regional Cancer Centre

• Patients were undergoing multiple phases of care.
• The study has clinical applicability for late effects and survivorship.

The study was a two-arm, single-blind, randomized, control trial comparing a 12-week, home-based, moderate intensity, PA behavioral change intervention to a contact control (CC) group.

• Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)
• Functional Assessment in Chronic Illness Therapy-Fatigue (FACIT-F) subscale
• Functional Assessment of Cancer Therapy-General (FACT-G) scale
• Beck Depression Inventory II (BDI-II)
• Positive and Negative Affect Schedule (PANAS)
• Body mass index (BMI)
• Waist circumference
• 12-minute Walk Test
• Pittsburg Sleep Quality Index (PSQI)
• Self-reported Seven-Day Physical Activity Recall

Four of 16 women in the PA group did not receive the intervention. The primary outcome, MFSI-SF, showed that the PA group had a significant decrease in fatigue postintervention (week 12) and at six-month follow-up compared to the CC group, with moderate to large effect sizes (d = 0.2; p = 0.001). The largest effect size on the MFSI-SF was on follow-up, suggesting that the benefits increased after completion of the 12-week intervention. No significant differences were found on any other secondary outcomes. The adjusted difference between means at follow-up for quality of life was clinically significant in favor of the PA group. No measurement tool for quality of life was specified by the authors. A mean of 10 telephone calls was made to both the PA and CC groups, with positive perception of the intervention based on exit questionnaires and focus group findings.

A PA behavioral change intervention is feasible with regard to program adherence and evaluation. The intervention may be helpful in improving fatigue.

• The study had a small sample size.
• The study lacked statistical power.
• The results were not generalizable.
• No standardized objective measure of PA was used.
• The high rate of ineligibility among women screened limited the sample size.
• There was a 25% drop-out rate for participants assigned to intervention group.
   

Suggestions for further study include

• Larger randomized, controlled trials to confirm the effects of the PA behavioral change intervention on fatigue
• Follow-up beyond six months
• The high rate of ineligibility suggests a need to investigate interventions for those ineligible due to comorbidities and advanced disease; one might question if an activity intervention in these subgroups would be advisable and if one would see a difference in participation/adherence to the program and similar benefits to the participants in this intervention group.
• Stratification according to tumor type may reveal differences between and among groups. 
• Encouraging  findings, both quantitative and qualitative, for eligible participants suggests efficacy and implies a need for testing in a larger multicenter study. The question remains as to whether time may be all that is necessary to modify cancer-related fatigue in this population.

The intervention was comprised of four weekly group meetings lasting 2.5 hours and a 5- to 15-minute telephone “booster session.” For one hour, participants were supervised by a kinesiologist or trained research nurse in walking training. A personal exercise program was established for each participant. Participants were encouraged to perform and keep records of their home-based assignments. Participants signed a contractual agreement to comply with recommendations, which were revised each week during the walking session. Participants were provided with ambulatory devices to help monitor their progress. The walking training was followed by a 1.5-hour session of psychoeducative and fatigue management techniques. Outcomes were assessed at baseline, postintervention, and at three-month follow-up.

• In total, 87 women with nonmetastatic breast cancer who had recently completed radiotherapy treatment were included.
• Mean age was 52.47 years.
• Of the participants, 65.5% were married, 71.3% were parents, and 37.9% were university graduates.
• Participants who showed signs of clinical depression, insomnia, or symptoms of recurrence or who had severe health problems other than cancer were excluded.

University hospital in Quebec City, Canada

Participants were undergoing the active treatment phase of care.

This was a randomized, controlled trial.

• Multidimensional Fatigue Inventory (MFI)
• Profile of Mood States (POMS)

At baseline, participants had moderate-intensity fatigue and energy levels. Women who received the intervention showed a significantly lower level of fatigue at follow-up compared with women in the control group. Similarly, women who received the intervention experienced statistically significant higher energy levels than the participants in the control group postintervention, particularly at the three-month follow-up.

• Participants in breast cancer research tend to be resource affluent and well educated, which limits the generalizability of the results.
• The participation rate was low due to time and travel requirements beyond what is required for standard medical care.
• The effects of nonspecific therapeutic processes, such as engagement and social interaction, were limitations, as participants in the experimental group spent more time with experts involved in the study than those in the control group.
• Analysis did not examine the benefits of the psychoeducative and exercise components of the intervention separately; it only evaluated the intervention as combined.

To test the proof of concept for a web-based intervention for fatigue designed to enhance self-efficacy in the management of cancer-related fatigue to inform the design of an effectiveness trial

This study was a multi-center, parallel-group, two-armed (1:1), exploratory, randomized (RESTORE or written leaflet), controlled trial with qualitative process evaluation. Patients were randomly assigned to receive an informational leaflet or participate in the use of a web-based program. The web-based program consisted of five sessions, including mandatory sessions on fatigue and goal setting and four other sessions that patients could choose from, that were presented to the patient at weekly intervals. The program also included videos of patient stories and automated tailored feedback components.

• N = 118 in trial, 159 in ITT
• AGE: 29–80 years
• MALES: 23.3%, FEMALES: 76.7%
• KEY DISEASE CHARACTERISTICS: Invasive cancer diagnosed five or less years prior to study, no evidence of metastatic disease, completed curative-intent cancer treatment 
• OTHER KEY SAMPLE CHARACTERISTICS: Self-reported moderate-to-severe fatigue, access to the Internet, had or were willing to establish an email account

• SITE: Multi-site  (N = 12)  
• SETTING TYPE: Not specified  
• LOCATION: United Kingdom sites

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Elder care

• Parallel group, two-armed (1:1), exploratory, randomized, controlled trial

• Fatigue self-efficacy
• Cancer survivor self-efficacy (Confidence in performing disease-related care activities)
• Brief Fatigue Inventory (BFI)
• Personal Wellbeing Index (PWI) (Satisfaction with life)
• Functional Assessment of Cancer Therapy-General (FACT–G) (Physical, social, emotional, and functional well-being)
• Patient Health Questionnaire-9 (PHQ-9) (Depression screen) 

FEASIBILITY: Forty-one percent of eligible patients consented to the study (16% of screened patients). The randomization process resulted in generally balanced groups with the exception of “not working” and “days since last cytotoxic treatment.” ACCEPTABILITY: Fifty percent indicated that the timing of program delivery was “about right”; others would have preferred earlier. Participants reported feeling supported and reassured that someone was interested in their fatigue. The attrition rate from consent to T2 was 36%. Seventy-one percent of participants determined to have adhered to intervention (completed sessions 1 and 2 and one of the remaining three sessions). No significant differences in symptoms or self-efficacy existed between groups.

Web-based resource (RESTORE) for the enhancement of self-efficacy in the management of cancer-related fatigue, pending recommended revisions, may be feasible and acceptable for use in research studies. Further study is needed to determine effectiveness.

• Baseline sample/group differences of import
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results
• Findings not generalizable
• Subject withdrawals ≥ 10%
• Dropout rate in RESTORE group was significant, and the significance of missing data limits the study.

Nursing implications include the cautious use of feasibility, acceptability, and adherence data for the completion of a web-based program to enhance self-efficacy in the management of cancer-related fatigue based on responses from multi-site participants in the United Kingdom.

To evaluate the psychological effects of presurgical stress management training

Subjects were randomized to the intervention or control group by week in the hospital. The intervention consisted of four sessions of meditative exercises, relaxation, guided imagery, and counseling to promote active coping and positive attitude. Sessions were completed on days 5 and 1 before surgery and days 2 and 30 postsurgery. Patients were given a CD with the same instructions to use at home. Assessments were done on days 6 and 1 before surgery and days 2, 5, 30, and 90 postsurgery. The control group received usual care.

• N = 70
• MEAN AGE = 52 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer; all stages undergoing surgery; most had lumpectomy

• SITE: Single-site
• SETTING TYPE: Multiple settings
• LOCATION: Netherlands

• PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ C30)
• Profile of Mood States (POMS) scale for fatigue and depression
• Subjective sleep quality scale
• Numeric Pain Rating Scale (NRS)

Anxiety decreased after surgery in both groups. Depression decreased in the intervention group after surgery and in the control group at three months postsurgery. Depression was significantly lower in the intervention group on day 5 after surgery (d = 0.47). Fatigue increased in the control group and was significantly higher than baseline at three months postoperatively. In the intervention group, fatigue decreased and was significantly below baseline at days 2 and 5 postoperatively. Sleep problems and pain did not change in either group. Across all study timepoints, differences between groups were inconsistent. Sometimes, symptoms were higher in the intervention group, and other times, they were lower in the intervention group. An analysis was done for changes from baseline for each group rather than between groups. There were only differences in the degree of change from baseline to postoperative days 2 and 5.

The effects of the intervention were inconsistent over time and appeared to be modest and short-lasting.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Key sample group differences that could influence results
• Measurement validity/reliability questionable
• Other limitations/explanation: Though small, the power analysis showed that the sample was sufficient to detect moderate effects. Baseline depression and fatigue levels were much higher in the intervention group, suggesting floor effects in the control patients. Six repeated measures could produce testing effects. There was no information about how often patients used the CDs at home. No information regarding other known intervention variables, including any adjuvant treatment during the study period, was provided.

The findings here were somewhat confusing and inconsistent over time; however, there were some potential short-term benefits for fatigue and depression. The combination of relaxation therapies and counseling is a low-risk intervention that may be helpful for some patients.

The comprehensive coping strategy program (CCSP) provided patients with information emphasizing the use of pain control to decrease psychological distress and physical symptoms, such as fatigue. Patients were provided with handouts that explained ways to reduce pain, the use of cognitive restructuring information on distorted thinking, and positive coping self-statements. Patients were taught how to perform a brief muscle relaxation, which included a guided imagery component. Handouts were provided that described relaxation therapy and its benefits. A handheld recorder was given to patients to guide them through the relaxation exercise. Patients were instructed to use a five-minute audiotape recording at least every day and before stressful events. Patients were instructed to record their use of audiotapes and handouts in a diary. Outcomes were assessed at baseline, two days before allogeneic bone marrow transplant (ABMT), and seven days after ABMT. 

• In total, 128 women with breast cancer scheduled for ABMT were included.
• Most patients were aged between 41 and 50 years.
• Of the patients in the CCSP group, 90% were married, which was significantly higher than the control group (57% married; p < 0.001), and 40% had practiced some earlier coping method, which was significantly higher compared to 21% of the those in the control group (p < 0.05).

National Cancer Institute (NCI)–designated comprehensive cancer center located in the eastern United States

Patients were undergoing the active treatment phase of care.

This was a randomized, controlled, prospective clinical trial that included

• Patients scheduled for ABMT who received the CCSP
• Patients scheduled for ABMT who received standard medical care.

Visual analog scale (VAS)

Fatigue was experienced by 91% of the participants. The peak fatigue level was observed days before ABMT for both groups; the CCSP group experienced a 10.80-point increase, and the control group experienced a 20.33-point increase. The CCSP group experienced a statistically significant improvement in fatigue seven days after ABMT in comparison to the control group (p < 0.05); however, this difference disappeared after controlling for demographic variables and fatigue two days prior to ABMT. An index of nausea and fatigue was created for day seven after ABMT, and there was a statistically significant difference between the groups, with demographic variables controlled, with the control group reporting more nausea and fatigue than the intervention group (p < 0.05).

The generalizability of the results was limited to the sample, which consisted primarily of highly educated, married, Caucasian women with high incomes.

The primary aim was to examine the effects of a nursing intervention for fatigue on children aged seven to 12 years who received chemotherapy. The secondary aim was to examine the relationship between fatigue and demographic variables, diagnoses, and therapy-related variables.

The experimental group received education about fatigue with chemotherapy and a fatigue handbook. Education provided included specific activities that decreased fatigue. Children were also walked in the hallway for physical activity. The control group was given routine nursing care. These activities were performed for one week. Participants were randomly assigned.

• The final sample size included 60 participants.
• Mean age was 9.23 years for the experimental group and 9.37 years for the control group. The percentage of males was 60% in the experimental group and 63.3% in the control group.
• Participants had acute lymphoblastic leukemia (ALL) (71.66%), acute myeloid leukemia (AML) (11.67%), and lymphoma (16.67%). 
• No significant differences were found between the groups in terms of age, diagnosis, sex, or hemoglobin level.

• Multisite
• Participants were recruited in the Department of Pediatric Oncology, Ege University Faculty of Medicine and Behçet Uz Hosptial of Children and SSK Tepecik Teaching Hospital, Clinics of Pediatrics.

This was a randomized, controlled trial.

• The Fatigue Scale-Child (FS-C) was used to measure participants’ fatigue and consisted of 14 items that describe the intensity of fatigue on a five-point scale.
• The Fatigue Scale-Parent (FS-P) used 17 items to assess parents’ perceptions of their child's fatigue on a five-point scale.
• The validity and reliability of both tests was assessed by 60 other similar children and parents.

The difference between the two mean values on the FS-C between the experimental and control groups was statistically significant (p < 0.00). The difference between the two mean values of the FS-P between the experimental and control groups was statistically significant (p < 0.00).

The study showed some promise for an intervention to reduce fatigue. However, fatigue was not eliminated in the experimental group, and baseline fatigue scores were not collected from either group.

• The control group received less attention.
• The experimental group had a limited age range and diagnosis, which may cause difficulty in generalizing the results.

It would be feasible to perform the study procedure for the experimental group in practice if the education continued to prove effective on fatigue.

The symptom-tailored, evidence-based intervention was delivered at two-week intervals over a 20-week period. Six contacts were delivered in person and four via telephone. The intervention was targeted to systematically assess and intervene when patients experienced symptoms of nausea, vomiting, pain, fatigue, insomnia, difficulty breathing, coordination problems, fever, cough, dry mouth, constipation, anorexia, diarrhea, or mouth sores. Pain and fatigue were sentinel symptoms in this study, and the supportive nursing intervention was directed toward these symptoms, as well as 12 other common symptoms. When symptoms (as evaluated every two weeks) reached a threshold level of intensity or bother/interference with function and quality of life, interventions to manage the symptom were selected collaboratively by the nurse and patient and were initiated and continued until the symptom resolved or until the 20-week intervention period ended. Once a symptom had reached such a threshold, the interventions (including teaching, counseling, support, coordination, and communication) were initiated. Every two weeks, the efficacy of the intervention strategies and the status of problem resolution were reevaluated. Intervention strategies were then adjusted or stopped based on the result.

• The patients (intervention group, n = 53; control group, n = 60) had a mean age of 58 years, and 72% were female.
• The majority of patients had at least some college education, and most were not employed at the time of the study.
• Eligible patients were those who were within 56 days of initiating their first cycle of chemotherapy following a new cancer diagnosis.
• All patients had to have reported pain and fatigue at their screening interview.
• Breast and lung cancers were the most common diagnoses, and about 70% of the sample had advanced stage disease (stages III–IV).
• There were no differences between the intervention and control groups in baseline measures of fatigue; there was equivalency between the two groups relative to sociodemographic and medical/treatment variables. There were no differences between the two groups at baseline in symptom distress or self-reported physical and social functioning.

• Multicenter trial
• Two sites affiliated with comprehensive cancer centers and two community cancer treatment clinics

Patients were undergoing the active treatment phase of care.

This was a randomized, controlled trial with a usual care control group.

• Symptom Experience Scale (developed by the investigators)
• Physical and social functioning

Substantially more patients in the experimental group (n = 10) reported neither pain nor fatigue at the end of the 20-week intervention, compared with only three patients who reported neither pain nor fatigue, although it was not statistically significant. There were statistically significant benefits of the intervention relative to other outcomes, such as total symptom distress, role, and social functioning.

• The sample was inadequately powered.
• The study had a small sample size.
• Not all covariates that could affect the outcomes were entered in the analysis.
• Generalizability was limited by the large number of participants with breast cancer.
• The intervention was delivered by professionals; costs were offset by the fact that some of the intervention can be delivered by telephone.

To explore the effects of a prostate-specific program on physical activity, fatigue, mental distress, and quality of life (QOL).

Courses were conducted by a multidisciplinary team, including lectures, physical activity, and group sessions, lasting for six days. Activity was performed in groups of six to nine patients twice daily, including water gymnastics, walking, Nordic walking, resistance training, pelvic floor training, stretching, and relaxation for 60 to 90 minutes. Group sessions met for one hour daily and were led by a nurse with experience in group counseling. Lectures involved presentation of medical facts, treatment modalities, late effects, and social and other benefits of physical activity. Study measurements were obtained at baseline and at three-month follow-up.

• Sixty-eight patients (100% male) were included, and 51 completed the entire program. 
• Mean age was 67.4 years (range 48.5–81.2).
• All patients had prostate cancer.
• Of the patients, 14% had metastatic disease, 43% had undergone surgery and radiotherapy, 20% had received radiotherapy, and 16% had received hormonal therapy.
• Median time since diagnosis was 18.2 months.
• Most patients were retired, 50% had completed college education, and 86% were married or cohabitating.

• Single site
• Inpatient
• Norway

Patients were undergoing the active treatment phase of care.

This was a prospective, observational study.

• Godin Leisure-Time Exercise Questionnaire
• Fatigue Questionnaire (physical score range 0–21; mental score range 0–12)
• Memorial Anxiety Scale for Prostate Cancer (MAX-PC)
• Hospital Anxiety and Depression Scale (HADS)
• European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLC-C30 QOL) scale

Total fatigue scores declined from 16.1 to 14.0 (p = 0.001), and physical fatigue declined from 11.1 to 9.2 (p = 0.001). Those who did not complete the entire program had higher baseline fatigue scores. Anxiety results were mixed:  anxiety declined on the prostate specific measure (p = 0.001), but there was no change on the HADS scale. QOL measures did not change significantly.

Although there was a significant reduction in fatigue, the degree of change was small (2 of 33 points possible). The study did not provide strong support for the effectiveness of this program.

• The study had a small sample size, with less than 100 patients.
• No control or comparison group was used.
• The sample was highly variable in terms of the age range, and the rehabilitative needs of younger patients who may have undergone curative surgery can be expected to be different than those of older patients; this was not analyzed.
• Use of an inpatient setting for six days for this type of program can be expected to be expensive.
• Time from surgery to study entry varied, and final measures were three months after the program, with no interim assessment; it is not clear what the best timing of such interventions are in the disease trajectory.
• There was no information regarding continued activity prior to the final study measures being obtained.

The results suggested a small effect of this type of program on fatigue and no significant impact on overall anxiety or QOL.

The patient education intervention was delivered in three sessions and consisted of:  one-to-one education, training and counseling, and audio-visual computerized educational materials. In session one (first cycle of chemotherapy treatment), patients were introduced to the project and were given information about fatigue and how to manage it, as well as a diary to record their daily feelings related to fatigue. In session two (second cycle of chemotherapy treatment), the nurse and patient engaged in an open interview about treatment, side effects, and daily activities of the patient and discussed the diary notes. In session three (one month after the completion of treatment), the patient discussed with the nurse changes in fatigue perception throughout treatment using diary notes. A questionnaire was completed by both the intervention and control groups at sessions one and three. Only the intervention group completed the questionnaire at session two.

• Forty patients who were chemotherapy-naïve with colorectal or gastric cancer (experimental group:  n = 23, mean age = 58.5 years [range 32–74]; control group:  n = 17, mean age = 62.7 years [range 49–75]) were included.
• Patients were excluded if they had received previous cancer treatment; had presence of respiratory, cardiac, or hepatic dysfunction; had a learning disability; had central nervous system metastasis; and/or had received previous radiotherapy.

• Single site
• Comprehensive cancer center in Barcelona, Spain

Patients were undergoing the active treatment phase of care.

The study used an experimental, randomized, stratified design.

• Functional Assessment of Cancer Treatment (FACT)
• Diary notes

Fatigue levels were lower for the intervention group after the second session in comparison to baseline and remained steady after one month posttreatment. Fatigue levels remained stable for the control group at baseline to one month posttreatment. These differences were not statistically significant.

• The study had a small sample size; therefore, it was underpowered.
• The observed difference may not be only due to the nursing intervention and can be attributed to outside factors, such as the response to medical treatment.
• The nursing intervention was slightly different according to needs of participants about fatigue, and the nurse was not always the same for all three sessions.

To test the hypothesis that depression and fatigue would be decreased more in the Sisters Tell Others and Revive Yourself (STORY) intervention group than in controls

The STORY intervention was a therapeutic activity delivered to a group via teleconference, using information and storytelling to increase social connections among African American women with breast cancer. A series to teleconferences was facilitated by two social workers with groups of 10 patients. The series was done weekly for eight weeks, and every other week for two weeks. Participants received small stipends during the study. Patients were randomly assigned to the STORY intervention or usual care. This particular report used secondary analysis to determine the impact of this intervention on depression and fatigue.

• N = 168
• MEAN AGE: 56.7 years
• RANGE: 32-83 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer.

• SITE: Single site
• SETTING TYPE: Not specified
• LOCATION: Southeastern United States

• Randomized, controlled trial

• Profile of Mood States Short Form (POMS-SF)

There was no significant difference in fatigue or depression between study groups.

The psychoeducational intervention delivered via teleconference as tested here did not demonstrate an effect on fatigue or depression.

• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Measurement validity/reliability questionable
• The single instrument used may not have been the best for measurement of these symptoms.
• The educational content regarding how to manage fatigue and depression are not described, and from the description that is provided, it is not clear that patients were educated about evidence-based approaches to combat fatigue.
• It is unclear whether levels of fatigue and depression were high enough to expect to see a reduction with an intervention.

The psychoeducational and supportive intervention tested did not show an effect on depression or fatigue. This report does provide information regarding using a teleconference approach to provision of a group intervention, which might be applicable in a number of situations to facilitate patient involvement in this type of activity. Further research regarding the most effective methods of delivery of educational and supportive interventions is needed.

To implement and evaluate an evidence-based practice change to encourage exercise for fatigue

The Iowa Model of Evidence-Based Practice Change was used to guide implementation and measure impact on patient outcomes and care processes. An intervention to implement physical activity for patients to combat fatigue was selected. Activity kits for patients were developed, and included information on the benefits of physical activity, activity logs, instructions for workouts, as well as strategies to improve sleep, and nutrition. A pedometer and resistance bands were also provided. A nurse made regular connections with patients to encourage physical activity. Fatigue assessment was done at clinic visits at baseline and three months later. Results from the physical activity group were compared to those of patients receiving usual care.

• N = 45  
• AGE: Not provided
• MALES (%): Not provided, FEMALES (%): Not provided

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Iowa

PHASE OF CARE: Multiple phases of care

Prospective cohort comparison

Brief Fatigue Inventory (BFI)

Patients who received the activity intervention experienced a significant reduction in fatigue (p = 0.0006) and increase in general activity (p = 0.0066).

The intervention to improve physical activity was effective to improve fatigue.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)
• A single DNP was involved in encouraging patients to continue physical activity, so if this type of practice change would be effective without the consistent follow-up of an individual is unclear.

The findings showed that the use of the activity kit and follow-up in this study was effective in increasing physical activity and reducing fatigue in patients with cancer.

To evaluate the impact of a nursing intervention incorporating structured symptom assessment and management of the chemotherapy-related symptoms of nausea, vomiting, fatigue, and mucositis.

A consecutive sample of 249 patients, who were scheduled to receive first-line chemotherapy, received structured symptom assessment and management, facilitated by WISECARE+, an information technology–based program. Symptom data was self-report by patients using a paper questionnaire for 14 consecutive days following each cycle of chemotherapy, starting on the first day of treatment.

• In total, 249 patients (22.9% male, 77.1% female) were included.
• Age was 15 to 85+ years.
• Patients had breast, lung, ovarian, or colorectal cancer; osteosarcoma; acute myeloid leukemia (AML); acute lymphoblastic leukemia (ALL); or lymphoma.
• Patients were chemotherapy-naïve, physically and psychologically fit adults.

• Multisite
• Inpatient and outpatient
• Pan-European:  eight clinical sites in Belgium, Denmark, England, Ireland, and Scotland

Patients were undergoing the active treatment phase of care.

The study used a pre- and postintervention design.

• The Chemotherapy Symptom Assessment Scale (C-SAS) rigorously tested for criterion validity, construct validity, test-retest reliability, and internal consistency (a = 0.75).   
• WISE Tool (electronic patient and symptom record/database):  No validity or reliability data were provided.

Patients experienced less nausea postintervention, but pre/post differences were only significant at days 0 to 4 (p = 0.025). Similarly, patients had less vomiting after the intervention but pre and post differences were only significant at days 0 to 4 (p < 0.001). Although changes in oral problems varied at different time points in the study, overall repeated measures analysis showed reduction in oral problems over the course of the study (p = 0.016). There was no effect of the intervention on fatigue.

Structured nursing symptom assessment and management of chemotherapy-related symptoms improved the symptoms of nausea, vomiting, and oral problems (mucositis) related to chemotherapy.

• No appropriate control group was used.
• The study sample was extremely heterogeneous, and the study was possibly underpowered.
• The study did not evaluate interventions specific to mucositis but, rather, the format or structuring of interventions. The study was not designed to specify if the oral problems were strictly mucositis.

The study used patient-assessed symptom data that was collected in real time. The data measured the incidence, severity, and associated distress of the symptoms. Additional research is needed to evaluate the effectiveness of the structured symptom assessment and management of chemotherapy-related symptoms.

Patients were randomly assigned to either the placebo control group or the intervention group after being stratified by work status and whether they were receiving hormone treatment. Patients in both the intervention and placebo control groups listened to brief tape-recorded messages in the clinic before their first and fifth radiation therapy treatments. The lengths of the audio-only tapes were four and eight minutes for each of these two treatments. A member of the research staff stayed with each patient while the tape recordings were played. The tape-recorded messages for the placebo control group contained general and global information that was generally available to all patients receiving radiation therapy, including resources available to them in the treatment setting. The messages also included self-care instructions to help patients control or lessen side effects. For the intervention group, the tapes were designed to deliver specific, descriptive, sensory messages regarding radiation therapy procedures and related information based on self-regulation theory, in addition to the same self-care instruction, as was given to the comparison group. The information was developed from descriptive data collected from men undergoing radiation therapy for prostate cancer and was tailored to match the standard practices of the radiation facility of each participating institution.

• In total, 152 men receiving radiation therapy as curative treatment for localized prostate cancer were included.
• Mean age was 70.8 years (range 44–85).
• Most patients were married (86%), retired (76%), Caucasian (96%), and had at least a high school education (88%).
• The distribution of disease stage was 13% with stage A, 66% with stage B, and 21% with stage C disease.
• Most patients (92%) did not receive hormone therapy.
• Thirty-four patients were employed.

Radiation oncology facility of one of eight cancer centers

Patients were undergoing the active treatment phase of care.

The study was a randomized, controlled trial with an attentional control group.

Profile of Mood States (POMS)

Patients who received the informational intervention containing detailed information concerning radiation therapy and potential side effects reported less severe fatigue at the second radiation treatment and at the conclusion of treatment than patients who received only general information.

• It was unclear whether group allocation was concealed from the investigators.
• Longer follow-up is indicated because fatigue might be expected to continue to increase in the weeks following the conclusion of radiation therapy.
• There were initial costs to develop the audiotapes.

To test the effects of a psychoeducational intervention on pain, fatigue, and sleep disturbance.

Patients were randomly assigned to the intervention group or the wait-list control group. The intervention consisted of a single one-on-one training session with a research nurse, which was followed by recorded guidance that provided imagery, relaxation exercises, and nature sounds. Most exercises lasted 20 minutes and were delivered via an mp3 player. The study lasted two weeks.

• The sample was comprised of 78 patients (41% male, 59% female).
• Mean age was 60.29 years (standard deviation = 11.09 years).
• Patients had lung, prostate, colorectal, or gynecologic cancer.
• Patients were receiving chemotherapy or radiation therapy and had multiple concurrent symptoms at baseline.
• At study entry, all patients had to have fatigue, sleep disturbance, and pain scores of at least 3 on an 11-point numeric scale.
• Of the patients, 71% were taking steroids, 59% were taking opioids, and 86% were taking antiemetics.
   

• Multisite
• Outpatient
• Midwestern United States

Patients were undergoing the active antitumor treatment phase of care.

The study used a randomized, controlled trial, pre- and postintervention design.

• Selected items from various instruments, including the Brief Fatigue Inventory (BFI), Brief Pain Inventory (BPI), and Pittsburgh Sleep Quality Index (PSQI)
• Eleven-point numeric scales, to measure symptoms
• Patient diaries, which recorded use of cognitive-behavioral therapy (CBT) exercises
• Symptom cluster score, calculated by averaging the pain, fatigue, and sleep disturbance scores
• Symptom interference subscale of the MD Anderson Symptom Inventory (MDASI)

• Comparison of pre- and postintervention symptom severity scores showed a significant reduction in the severity of pain, fatigue, and sleep disturbance and symptom interference (p = 0.000).
• Symptom cluster scores and individual symptom scores declined in both the intervention and control groups.
• The reductions in symptom cluster severity (p < 0.05), pain (p < 0.01), and fatigue (p < 0.05) were significantly greater in the intervention group than in the control group; however, the effect sizes (calculated as partial eta) were extremely small (range 0.041–0.093).

The intervention demonstrated a small statistically significant effect on the symptoms of pain and fatigue and the overall symptom cluster of pain, fatigue, and sleep disturbance.

• The study had a small sample size, with less than 100 patients.   
• The study had risks of bias due to no blinding and no appropriate attentional control condition.
• The sample included baseline and group differences of import.
  • The control group had higher depression scores at baseline than did the intervention group.
  • A greater number of those in the intervention group dropped out of the study, suggesting that the intervention was not well accepted. Intention-to-treat analysis used the last value carried forward. If symptoms worsened, this would produce biased results.
• Although the intervention was called a CBT intervention, whether cognitive reframing or problem solving was a part of the intervention was unclear. The intervention appeared to have been a relaxation or imagery therapy.
• Measurement validity and reliability were questionable.
  • Authors used Z-scores to compare sleep disturbance severity, rather than actual scores; the reason for this was unclear. The actual change in Z-scores for this symptom was larger than the score changes associated with other symptoms, but the Z-score change was not statistically significant.
  • Whether average individual symptom scores were more meaningful than the total score for the cluster was unclear.  
• The intervention may be too expensive or impractical, in terms of training needs, to be feasible.

The intervention was a relaxation or imagery therapy rather than a true CBT. The intervention was associated with short-term statistically significant benefits, but the actual size of the effect was small. Findings suggested that approaches using relaxation and imagery may result in some small benefit for patients, but the effect was weak.

To investigate whether a web-based self-management exercise and diet intervention (WBSEDI) is feasible and effective in patients with breast cancer to promote exercise and diet

Control versus 12-week WBSEDI. WBSEDIs were encouraged to be completed at least twice weekly. Education content included enhancing exercise and diet behavior in survivors; the importance of weight management; barriers to sustaining exercise and diet; planning exercise and diet; outcomes of regular exercise and diet; and exercise and diet recommendations for cancer survivors. Content was divided into modules based on patients' stage of change. The type and duration of exercise was decided by the patient. Diets were based on daily calorie requirements and food-group unit recommendations. Automatic feedback was provided in the module. The control group received a 50-page booklet of module information without transtheoretical model use.

• N = 57  
• MEAN AGE: 43.2 years (control group), 41.5 years (experimental group)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Mean time since treatment = 156.6 days (control), 161.6 days (experimental). 43/59 patients had breast-conserving therapy, 49/59 patients received chemotherapy, and 52/59 patients received radiotherapy. All participants completed primary therapy within last 12 months before study enrollment.
• OTHER KEY SAMPLE CHARACTERISTICS: Percent completing college or beyond: Control 69%, experimental 76.7%

• SITE: Multi-site    
• SETTING TYPE: Home    
• LOCATION: South Korea

• PHASE OF CARE: Late effects and survivorship

Pilot randomized controlled trial

• Primary outcomes: Exercise and fruit and vegetable intake, dietary quality using diary and recall.  
• Secondary outcomes: Health-related quality of life (HRQOL) using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ–C30) 
• Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS) 
• Fatigue using the Brief Fatigue Inventory (BFI) 
• Stage of change using open-ended questions 
• Perceived self-efficacy using Likert scale

89% of the experimental group consistently participated in the intervention. There was a significant increase in the intervention group for moderate-intensity exercise of 150 minutes per week (p < .0001) and five servings fruits and vegetables per day (p = .001). Secondary outcomes were significant improvements in the intervention group at 12 weeks for physical functioning (p = .023), fatigue (p = .032), and appetite loss (p = .034). The stage of change for exercise and fruit and vegetable consumption was significantly higher (p < .0001 and p = .029).

The intervention arm had a low attrition rate with a high percentage of participation. Secondary outcomes such as fatigue were associated with improved primary outcomes, suggesting increased exercise and improved diet can have an effect on quality of life and function for breast cancer survivors. Patient stage of change can affect participation in interventions. The cost and implementation of web-based intervention was not discussed, which may limit some institutions in using it.

• Small sample (< 100)
• Risk of bias (no blinding)
• Intervention expensive, impractical, or training needs
• Other limitations/explanation: Large number of identified patients excluded from study (113/172)

Web-based interventions may be effective for patients seeking lifestyle interventions that include ongoing support and feedback.

The residential, rehabilitative, psychoeducational intervention was conducted over a six-day period, followed by a four-day follow-up/booster intervention two months after the initial visit. Members of the intervention team included oncologists, social workers, art therapists, massage therapists, and a person trained in qigong and visualization; all had several years of experience and were trained according to the method reported by Grahn (1993). During the intervention period, participants received information about cancer, risk factors, treatment, psychological effects, and coping mechanisms. Physical exercise, relaxation training, qigong, and art therapy were mixed with educational lectures. Social activities, such as concerts and visits to museums and restaurants, were provided, along with opportunities for peer support. The residential rehabilitation environment was chosen for its beautiful and restful surroundings.

• Participants (n = 59) were primarily women; only two men participated.
• Median age was 53 years (range 29–81).
• Diagnoses included breast cancer (61%), gynecologic cancer (20%), and gastrointestinal malignancy (9%).
• Median time from end of treatment to the intervention was 1.2 years (range 6 months–3 years).

Residential rehabilitation setting selected specifically for the intervention

Patients were undergoing the long-term follow-up phase of care.

This was an uncontrolled study. Fatigue was evaluated immediately after the first six-day intervention, with follow-up at three, six, and 12 months postintervention.

The Norwegian fatigue questionnaire, an 11-item measure with two factors (physical and mental fatigue), was used. The total score was created by summing the 11 items.

At the conclusion of the intervention, there were statistically significant differences in fatigue reflected on most of the single-item scores on the Norwegian fatigue scale, as well as a statistically significant difference in the scores on the physical fatigue and mental fatigue factors. Only the improvement in physical fatigue remained statistically significant at three-month follow-up, and there were no significant improvements in fatigue at the six- and 12-month postintervention time points.

• No control group was included.
• The sample size was not justified by power analysis; it was unknown whether the study was powered to detect an effect.
• No information was provided relative to the psychometric properties of the fatigue measure.
• No explanation of the gender bias in study participation/recruitment was offered.
• Generalization of the results was limited by the primarily female sample and the overrepresentation of participants with breast and gynecologic malignancies.
• Costs of residential group treatment were unexplored.
• The program required the involvement of several skilled professionals.

To examine whether providing pre-, post-, or pre-/post-radiotherapy fatigue education and support (RFES) reduced the severity of fatigue at the end of six weeks post radiotherapy.

A 60-minute session was held using a PowerPoint presentation, participant handbook, goal setting sheet, and progress diary. Follow-up telephone calls were made to patients two and four weeks after the session to reinforce the information. Content included radiotherapy processes, side effects, and behaviors to reduce fatigue, such as activity modification, sleep hygiene, and relaxation.

• In total, 91 patients (49% male, 51% female) were included.   
• Mean age was 57.65 years.
• Cancer diagnoses included were breast (34%), prostate (33%), other diagnosis (13%), melanoma (11%), and head and neck (9%).
• Length of radiotherapy was 29.5 days.

• Single site   
• Outpatient
• Radiation oncology department of a major metropolitan hospital in Brisbane, Australia

Patients were undergoing the active treatment phase of care.

The study used a three-group, quasiexperimental, pre/post design.

• Medical Outcomes Study (MOS) Sleep Scale
• Multidimensional Fatigue Inventory (MFI)
• EuroQol-5D (EQ-5D)
• Frenchay Activities Index (FAI)
• International Physical Activity Questionnaire (IPAQ)
• Hospital Anxiety and Depression Scale (HADS)
• Health and Labour Questionnaire (HLQ)
   

Pre-RFES showed no improvement in fatigue compared to no pre-RFES. Post-RFES showed no improvement in fatigue compared to no post-RFES.

Patient-reported fatigue was unaffected by the intervention for any of the time points it was delivered.

• The study had a small sample size, with less than 100 patients.
• No appropriate nonintervention control group was used.

 Additional interventions should be considered when attempting to alleviate fatigue in patients receiving radiotherapy.

To help patients manage fatigue, as well as optimize activity and functioning, through energy conservation and management.

The intervention was comprised of four principle components:

• Detailed assessment of fatigue
• Provision of an educational pack on fatigue management
• Monthly meetings to facilitate the provision of advice and coaching on fatigue management strategies
• Exploration of the meaning of fatigue for patients in their daily lives.

The intervention was provided over the first three treatment cycles.

• In total, 103 (55% male) chemotherapy-naïve patients diagnosed with non-Hodgkin lymphoma or gastrointestinal, non-small cell lung, colorectal, breast, or unknown primary cancer were included.
• Mean age was 56.5 years.
• The disease group was most commonly esophageal (22%), and the disease status was most commonly locoregional disease (45%).
• Patients were excluded if they were being treated for psychiatric illness.

• Multisite
• Inpatient and outpatient
• Clinics at two regional cancer centers in the United Kingdom

Patients were undergoing the active treatment phase of care.

The study was a randomized, two-arm (standard versus experimental treatment), unblinded, controlled trial.

• Visual analog scales (VASs):  subjective quantification of fatigue, subjective distress because of fatigue, and subjective assessment of fatigue effects on chores/work and pastimes/hobbies
• Fatigue diary
• Short Form 36 Health Survey (SF-36)

The experimental group experienced a 20% pre-/posttest decrease in the different dimensions of fatigue, whereas a negligible difference was observed for the control group. Across all measures of fatigue (VASs and the vitality subscale of the SF-36), the experimental group reported less fatigue by the end of the study than the control. The intervention was particularly successful in decreasing distress evoked by fatigue (p < 0.01) and reducing the impact of fatigue on favored pastimes (p < 0.02). Analysis of the mean fatigue score revealed a significant between-group difference in global fatigue (p < 0.03).

• Patients were at liberty to receive fatigue management information and support from outside sources.
• The study was unblinded; therefore, it was possible that patients in the treatment group experienced a placebo effect and that investigator bias may have impacted the results.
• Cost data were not collected; therefore, it was not possible to assess the cost-effectiveness of the intervention.

To evaluate a patient education program aimed at reducing fatigue.

Patients were randomly assigned to intervention or wait-list control groups. The intervention consisted of group education and support sessions for 90 minutes once weekly for six weeks. Data were collected at baseline and at six weeks and six months postintervention. Patients were encouraged to keep a diary at home, perform exercises, and implement lifestyle changes.

• In total, 234 patients (2.6% male, 97.4% female) were included.
• Mean age was 57.5 years.
• Patients had breast, colon, and prostate cancers.
• Greater than 90% of the patients had fatigue for longer than six months. Baseline fatigue scores from multiple tools showed that patients were highly fatigued and had significant fatigue interference with daily activities.

• Multisite 
• Outpatient 
• Germany

Patients were undergoing the late effects and survivorship phase of care.

The study was a randomized, controlled trial.

• Fatigue Assessment Questionnaire
• European Organisation for Research and Treatment of Cancer Quality of Life (EORTC-QOL)
• General Self Efficacy (GSE) Scale
• Exercise Self Efficacy (EXSE) Scale
• Frieburg Questionnaire on Physical Activity
• Hospital Anxiety and Depression Scale (HADS)
• Fatigue Knowledge Scale (developed by the investigator)
   

Analysis showed that, over time, fatigue was significantly reduced in the intervention group (effect size of partial eta² = 0.248; p < 0.001). GSE and EXSE improved over time in the intervention group but declined in the control group.

Findings demonstrated that the psychoeducational intervention was effective in reducing cancer-related fatigue.

• The study had risks of bias due to no appropriate attentional control condition and no blinding.
• Unintended interventions or applicable interventions were not described that would have influenced the results (no information was provided about the use of medications or other interventions that could have influenced the outcomes).

The study adds to the body of evidence that supports the effectiveness of psychoeducational interventions for the management of cancer-related fatigue. This group of patients was very fatigued at baseline, and the effect size of the intervention was substantial, suggesting that the psychoeducational approach effect was clinically meaningful in a challenging group of patients.

To evaluate if stress management delivered in group or individual settings improved fatigue and emotional reactivity among newly diagnosed patients with breast cancer

Group stress management (GSM) consisted of 10 two-hour sessions over three months. Homework was assigned between sessions and discussed in the group. Sessions were cognitive behavioral (CBT) therapy-based with specific subjects: introduction to stress and stress response, negative thoughts and stress behavior, irritability and anger, quality of life, expectations of life, reactions to a cancer diagnosis, sexuality, and recapturing. Individual stress management (ISM) consisted of four to eight one-hour sessions over four and a half months using the same subjects from thee GSM group. Subjects were offered additional sessions as needed. Subjects also were given homework assignments between sessions. Both groups were led by a nurse trained in the intervention, which was also manual-based.

• N = 155 included in analysis  
• MEAN AGE = 57 (GSM), 58 (ISM)
• FEMALES = 100%
• KEY DISEASE CHARACTERISTICS: Stages I–III patients with breast cancer who received surgery and were about to receive chemotherapy, radiation, or hormonal therapy. In the GSM group, 54 patients received resection and 21 received a mastectomy. In the ISM group, 45 patients received resection and 32 received a mastectomy. For adjuvant treatment in the GSM group, 49 patients were to receive chemotherapy, 59 were to receive radiation, and 39 were to receive hormonal therapy. For adjuvant treatment in the ISM group, 40 patients were to receive chemotherapy, 55 were to receive radiation, and 45 to receive hormonal therapy.

• SITE: Multi-site    
• SETTING TYPE: Multiple settings    
• LOCATION: Falun, Gavle, and Uppsala hospitals

• PHASE OF CARE: Active antitumor treatment

Nonblinded, randomized, controlled trial that was randomized at three-month timepoints after enrollment if cutoff scores on the Hospital Anxiety and Depression Scale or the Impact of Events Scale were met or were higher

• Multidimensional Fatigue Inventory (MFI-20)
• Everyday Life Stress Scale (ELSS)  
• Demographics and medical information also collected

At the three-month evaluation, 304 women met eligibility requirements for randomization and 149 declined. Forty-two of 77 (52%) women who were randomized to the GSM group attended group sessions and completed an average nine of 10 sessions. Seventy-one of 78 women who were randomized to the ISM group completed an average of five of eight sessions. Those who declined participation in both groups reported significantly less activity. Results were compared at 12 months to three months. There were no significant changes over time and no significant changes between the GSM and ISM groups on fatigue or emotional reactivity. There was no significant difference over time in MFI-20 or ELSS scores. Thirty-one percent of participants who refused participation cited a lack of distress as the reason.

This study demonstrated no significant improvement in fatigue for patients breast cancer who participated in a CBT-based group or an individual intervention.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Subject withdrawals ≥ 10%

The willingness of patients to participate in group interventions should be considered when developing such programs.

To develop, run, and evaluate a program for patients with cancer at any stage of their illness.

Groups of no more than six patients were led by an occupational therapist and a physiotherapist for two to three hours per session for four weeks. The program involved group discussion and support, practical sessions, information, and homework to achieve individual goals. Information was collected through evaluation forms and fatigue scales. Patients were invited to attend the program by clinical nurse specialists (CNSs).

• Twenty-eight patients (23 females, 5 males) completed the fatigue course.
• Age ranged from 37 to 82 years, with the majority being in their 50s and 60s.
• Diagnoses included were gynecological cancer (43%), breast cancer (18%), lung cancer (11%), and other (28%).
• Stages of treatment ranged from curative to palliative.

• Single site
• Patients were recruited from clinical sites through CNSs from groups in Doncaster.

The study was a prospective trial.

Evaluation forms included a linear analog scale using a 0-to-10 scale and a comment field about their opinion of the program.

Patients reported positive thoughts about the time of the course, the location, and the knowledge of the instructors.

The study demonstrated a program that can potentially be used in a fatigue population that desires a group therapy intervention. Patient reports were positive, and no adverse effects were reported.

• The study had risks of bias due to no control or blinding procedures.
• Data were given as patient opinion and, therefore, could not be analyzed statistically.
• There may also be some issue in terms of staff required to lead the group sessions.

The study intervention could be easily taught to nurses desiring this type of intervention for their patients if the intervention proved effective.

To evaluate the effectiveness of a three-week educational intervention on patients' levels of fatigue

The intervention was comprised of a printed educational package that contained basic information about fatigue with three face-to-face two-hour sessions once a week that were tailored to the specific needs of the patient groups. The control group received no educational sessions. They did receive standard face-to-face care provided by a healthcare provider in an outpatient clinic. Study measures were obtained at baseline, immediately after the intervention, and at three months.

• N = 160 (81 control group; 79 intervention group)  
• MEAN AGE = 55.3 years (SD = 25–77 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTIC: Early-stage breast cancer 
• OTHER KEY SAMPLE CHARACTERISTICS: Fatigue score was > 2.5 on a 0–10 numeric rating scale. Most subjects were university/college-educated, married/partnered, lived with someone, and were employed.

• SITE: Single-site    
• SETTING TYPE: Outpatient    
• LOCATION: Norway, university-based breast cancer clinic

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care  

Randomized, controlled trial

• Demographic questionnaire
• Clinical questionnaire
• Numeric rating scale (Fatigue)
• Fatigue Questionnaire (FQ)
• Lee Fatigue Scale (LFS)

This study demonstrated no statistically significant differences between groups or within groups for any fatigue measures.

More research is needed to identify important variables that might affect the experience of fatigue as well as the effectiveness of the type of psychoeducational interventions in women with breast cancer.

A standardized psychoeducational intervention alone may not be sufficient to affect the experience of fatigue among women with breast cancer. Nurses can use the critique of the methods and instruments used and learn about reasons for withdrawing/not completing interventions/evaluations by research subjects to apply to future studies.

To report on health-related quality of life (HRQOL) and depressive outcomes from an earlier trial using nurse counseling after intervention (NUCAI)

Nurses delivered as many as six 45–60 minutes sessions every two months. The sessions consisted of six components: completing a Hospital Anxiety and Depression Scale before each session to lead a discussion of current mental state, having a discussion of current physical problems, having a discussion of life functioning, providing the AFTER (Adjustment to Fear, Threat, or Expectation of Recurrence) intervention, providing general medical assistance, and referring patients to psychological care. The AFTER intervention had four components: expressing fear of recurrence, identifying beliefs about recurrence, evaluating self-examinations, reducing excessive checking behavior, and relaxation. Usual care was provided twice monthly in sessions about complications and monitoring for recurrence. Patients were referred for psychological aftercare if psychosocial problems were assessed.

• N = 179  
• MEAN AGE = 60.1 years (intervention), 60.7 years (control)
• MALES: 70%, FEMALES: 30%
• KEY DISEASE CHARACTERISTICS: Intervention type of cancer: 23% larynx, 47% oral cavity, 18% OP, and 13% hypopharynx; control type of cancer: 24% larynx, 19% oral cavity, 48% OP, and 8% hypopharynx; intervention tumor stage: I–II 58% and III–IV 42%; control tumor stage: I–II 59% and III–IV 40% 
• OTHER KEY SAMPLE CHARACTERISTICS: Working status intervention: employed 35%, unemployed 33%, retired 22%, and unknown 10%; working status control: employed 37%, unemployed 37%, retired 23%, and unknown 2%

• SITE: Single site    
• SETTING TYPE: Not specified    
• LOCATION: Utrecht, Netherlands

• PHASE OF CARE: Transition phase after active treatment

Single, blinded, randomized, controlled trial

• Questionnaires were completed at baseline before cancer treatment and at three, six, nine, 12, 18, and 24 months after treatment completion.
• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck (EORTC QLQ-C30 H&N 35)
• Center for Epidemiologic Studies Depression Scale (CES-D)
• Demographic and medical information collection

50% of patients were lost to follow-up, the majority of which were because of death or terminal disease. At 12 months, statistically significant differences in physical functioning, emotional functioning, pain, swallowing, social contact, opening the mouth, coughing, and depressive symptoms were present. At 18 months, statistically significant differences in global quality of life, role functioning, emotional functioning, pain, swallowing, opening mouth, and depressive symptoms were present. At 24 months, statistically significant differences in emotional functioning and fatigue were present. Appointments were difficult to complete at times because of the clinic environment.

The NUCAI showed significant improvements for patients with head and neck cancer 24 months after completing treatment.

• Risk of bias (no blinding)
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10% 
• Other limitations/explanation: High attrition rate because of disease state; several analyses of data; fatigue measured as one aspect of multicomponent quality of life

As a nurse-led intervention, this is a feasible option for patients with head and neck cancer desiring a problem-focused intervention for symptoms.

The aim of the Nucare program intervention was to educate individuals with cancer on how to cope with the disease. Didactic materials consisted of a workbook, a cassette/CD guide to supplement the workbook material, and music to accompany the relaxation training component. The following eight components were emphasized in the Nucare program:  good coping, ways of thinking, communication, effective use of social support, problem-solving techniques, goal setting, healthy lifestyle, and relaxation training. The intervention was delivered in three formats:  (1) small-group (three to four participants with a trained therapist), (2) one-to-one (a participant and a therapist); or (3) home (the participant was provided with didactic material to use at home with no therapist). Data were collected at baseline and three to four months later.

Patients were included if they 

• Had primary head and neck cancer
• Were up to 36 months following diagnosis
• Were posttreatment.

Baseline

• Sixty-six participants (78.8% male) were included.
• Mean age was 56.7 years (range 30–84).
• Of the participants, 78.8% were male, 63.6% were retired or working, 65.2% had high school education or less, 69.7% were with a partner or relative, 56% were late stage, the majority (30.3%) had larynx cancer, 48.5% had received combination radiotherapy (RT) and surgery, 90.9% had no history of cancer, and 87.9% had no recurrence.

Follow-up

• Forty-five participants (80% male) were included.
• Mean age was 57.3 years (range 30–84).
• Of the participants, 70.1% were retired or working, 57.8% had high school education or less, 84.1% were with a partner or relative, 66.7% were late stage, 40% had pharyngeal cancer, 55.6% had received combination RT and surgery, 91.1% had no history of cancer, and 91.1% had no recurrence.

Patients who were in palliative or terminal care or who were unable to complete the outcomes questionnaires were excluded.

Outpatient clinic at the Jewish General Hospital in Montreal

Patients were undergoing the active treatment phase of care.

The study used a feasibility, prospective, nonrandomized design.

European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30)

On the EORTC QLQ-C30, a statistically significant improvement was observed in fatigue (p < 0.05) in the intervention group. The control group showed deterioration at follow-up, but it was not significant.

• The study design lacked randomization, and age/gender distributions were dissimilar between the intervention and control groups.
• The sample size was determined by logistical and financial restraints.
• The study had a small sample size.

To present the short-term effects of a web-based computer-tailored intervention on quality of life, anxiety, depression, and fatigue in cancer survivors

A stand-alone web-based computer-tailored intervention (Cancer Aftercare Guide: KNW) was applied that aims to increase cancer survivor quality of life by providing personalized information and support on specific topics by promoting lifestyle changes. The eHealth intervention was based on principles of the problem-solving theory (PST) and cognitive behavioral theory (CBT). The KNW consists of eight training modules on topics of return to work, fatigue, anxiety, depression, social relationship and intimacy, physical activity, diet, and smoking cessation. After online registration, the computer randomly assigned participants to the intervention or waiting control group. Both groups had to complete questionnaires at 3, 6, and 12 months from baseline. The 6 and 12 month measures revealed the effectiveness. Participants filled in baseline questionnaires, modules were selected by the program, and the information was tailored to the participant, resulting in a personalized action plan. After 30 days, participants were invited to a second session to evaluate goal attainment and to set new goals.The program was unrestricted so that participants could self-select modules they wished to use and skip assignments.

• N = 419   
• AGE = 18 years or older
• MALES: 19%, FEMALES: 81%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Any cancer survivor
• OTHER KEY SAMPLE CHARACTERISTICS: Off treatment for at least four weeks but no longer than 56 weeks; no recurrence; no serious psychiatric, medical, or cognitive impairment

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: Netherlands

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Elder care

Randomized, controlled trial comparing the KNW intervention with a waiting list control group

• Global health status scale
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
• Hospital Anxiety and Depression Scale (HADS)
• Checklist Individual Strength

With the exception of treatment type, the intervention and control group were comparable. Participants in the intervention group used an average of 2.22 modules from first login to last use of 10.67 weeks. The authors indicated that the KNW intervention had a significant effect on increasing emotional and social functioning (p = 0.022, p = 0.011) and decreased depressions and fatigue (d = 0.019, p = 0.007, d = 0.020, p = 0.02) six months after baseline. The only effect for fatigue occurred in participants who used the module Fatigue (p = 0.009). No significant differences existed between groups for anxiety. For those who used the therapist face-to-face component, available effect sizes ranged from 0.26 to 0.38.

While the use of the web-based intervention showed statistically significant results, the effect sizes for depression, anxiety, and social functioning were extremely small. The module use and program were not fully automated and offered direct therapist contact. The authors reported substantially higher effect sizes with therapist contact, raising the question of overall effectiveness of the web-based content.

• Baseline sample/group differences of import
• Risk of bias (no appropriate attentional control condition)  
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results
• Key sample group differences that could influence results 
• Measurement/methods not well described

eHealth interventions, such as web-based PST or CBT approaches, may be useful for improving quality of life in cancer survivors. Further research is necessary to target the desired information and to provide support specifically for fatigue, anxiety, and depression in cancer survivors. The findings showed much greater size of effects with direct therapist intervention, suggesting that an eHealth system may be best used as an initial step in a multicomponent intervention with additional steps, in which increasing intervention is provided based upon patient need and response.

Patients were given a 20-minute audiotape that provided information about exercise and relaxation to manage anxiety, fatigue, and sleep problems. A printed self-care diary (SCD) of self-care behaviors that mirrored the audiotape was also provided. Participants were instructed to listen to the audiotape 12 to 24 hours before the start of chemotherapy cycles and as often as desired during the course of treatment. Patients in the control group received the standard education and care given to all patients during chemotherapy, whereas the experimental group received standard education and care, the audiotape, and the printed SCD.

• The study included 71 women (control group, n = 33; experimental group, n = 38) who were newly diagnosed with breast cancer; 85% had stage I or II breast cancer.
• Mean age was 50.41 years (range 30–74); 50% were younger than 50 years. 
• Of the women, 50% were Black, 56% were Caucasian, and a few were Hispanic.
• Mean education level was 13.23 years (range 6–24).
• Of the women, 60% had an income of less than $29,000 (US).
• About half of the women were married.
• Most women received cytoxan/adriamycin; less than 13% received cytoxan/adriamycin/5FU.
• Patients were excluded if they were undergoing any therapy other than chemotherapy, were younger than 18 years, had a Karnofsky Performance Status (KPS) rating of less than 70%, or were non-English speaking.

• Multisite
• Tertiary medical center in the Southeastern United States and a satellite cancer treatment clinic 

Patients were undergoing the active treatment phase of care.

This was a randomized study; patients were randomly assigned to either the control or experimental group.

SCD

A higher percentage of women in the control group reported fatigue compared to the experimental group. Although the experimental group increased the number of self-care behaviors to address fatigue compared to the control group, this difference was not statistically significant.

• There was no control over information from outside sources that was provided to the women at the time of treatment; therefore, this varied between patients.
• The lack of significant findings may be due to insufficient use of self-care tapes, and measures to promote compliance will be needed in the future.
• The study had a small sample size.

The primary aim was patient evaluation of the usefulness of information provided. The secondary aim was to assess whether patients reported exercising during cancer treatment.

Patients starting a course of radiotherapy or chemotherapy (inpatient and outpatient) at Tayside Cancer Centre in the United Kingdom were given a “Fatigue Initiative” folder containing information on fatigue combined with advice on starting aerobic walking exercise during treatment. Patients were also encouraged to attend workshops on fatigue management as listed on flyers in the folder. Materials included home exercise information, walking information, and a guide for good sleep.

• In total, 146 patients (90 females, 115 males) were included. 
• Mean age was 63.4 years. 
• Patients had genitourinary (n = 119), gynecologic (n = 37), breast (n = 46), and other (n = 3) cancers.
• There were four treatment groups:  radical radiotherapy, postoperative radiotherapy, palliative radiotherapy, and chemotherapy.

United Kingdom

This was an observational cohort study.

• The Brief Fatigue Inventory (BFI) was used to assess level of fatigue before and after cancer treatment. The tool was administered four times:  at baseline, end of treatment, and the first and second follow-up visits. 
• Two study evaluation questionnaires were used:  one rated information usefulness and one provided information regarding exercise. No questions or scores were provided.

Overall, patients reported an increase in fatigue from baseline to the end of cancer treatment and from baseline to the first follow-up. Of the patients, 70% to 78% rated the information on fatigue helpful. Patients who said they used the information were more likely to exercise (odds ratio [OR] = 3.71; 95% confidence interval [CI] [1.19, 11.56]; p = 0.024). Patients who received radiotherapy were more likely to exercise than those receiving chemotherapy (OR = 14.9; 95% CI [2.43, 81.53]; p = 0.003). Higher levels of fatigue were reported by patients who used the information provided. Patients who exercised (p < 0.001), were older (p = 0.001), had other than breast cancer (p = 0.018), and who were not receiving chemotherapy (p < 0.05) reported lower fatigue scores on the BFI. Ten patients participated in a fatigue workshop.

Findings supported the positive effect of exercise on fatigue during cancer treatment and identified that age, breast cancer, and treatment with chemotherapy rather than radiotherapy were associated with the level of fatigue experienced. Findings suggested that the provision of written educational/informational materials can be helpful in encouraging patients to exercise.

• No appropriate control group was used.
• Time intervals varied between baseline and end of treatment for those receiving palliative radiotherapy (one to two weeks), radical or postoperative radiotherapy (four weeks), or chemotherapy (four months).
• Workshops were held in palliative care centers.

Fatigue did not decrease in any group. The study demonstrated the importance of providing information on fatigue encouraging a walking/home exercise program. Patients who were able to exercise during treatment had lower fatigue levels. The finding that those who used the information had higher levels of fatigue may suggest that patients who have the most fatigue are more likely to use information to help them cope with it.

An individualized psychoeducational intervention was delivered in one face-to-face session lasting 20 minutes, followed by two telephone sessions of approximately 10 minutes each. The intervention sessions were delivered at weekly intervals. Participants were also given written materials on fatigue management. The intervention focused on helping patients develop knowledge and skills to engage in self-care behaviors that may decrease fatigue, including increasing mobility/activity, effective use of available energy reserves, and management of sleep disturbances, anxiety, and psychological concerns. The intervention also addressed the predisposing, reinforcing, and enabling factors for self-care, including beliefs, attitudes, and perceptions that might facilitate or hinder a person’s motivation to perform the desired behaviors and use the skills and resources necessary to perform the behaviors and feedback provided by family or health professionals that might influence continuance or discontinuance of the behaviors. Each session was tailored to the patients’ specific needs and circumstances and was designed to target these influencing factors. Scripts and intervention protocols for both the treatment and attentional control groups were provided by the investigators. Efforts to facilitate standardization and quality control in the delivery of the interventions were described.

• The study included 109 women beginning adjuvant chemotherapy for stage I or II breast cancer. 
• Mean age was 49.4 years (range 26–70).
• Approximately 65% had completed post-high school education, and most were from relatively high socioeconomic backgrounds.
• Of the patients, 77.4% were married.
• There were no significant differences between the interventional and control groups for any other medical variables.
• All participants had an Eastern Cooperative Oncology Group (ECOG) performance status of 1 or 2, and their hemoglobin levels were at least 11.6 g/mL at recruitment.

One of five outpatient chemotherapy/day treatment facilities in a major metropolitan setting

The study was a randomized, controlled trial with an attentional control group and concealment of group allocation. Randomization procedures and attentional control conditions were used explicitly.

• Investigator-Developed Instruments: Fatigue Management Behaviors, Confidence with Managing Fatigue, and numeric rating scales for fatigue
• Revised Piper Fatigue Scale (PFS) 
• Functional Assessment of Cancer Therapy-Fatigue (FACT-F)

The most commonly used self-care actions for fatigue reported at baseline were rest, hydration, relaxation, exercise, and listening to music. Use of these actions remained relatively stable over time, and there were no significant differences in usage between groups. Patients in the intervention group reported a significantly greater mean increase in the number of actions recommended by health professionals compared with patients in the control group. There were notable increases in mean fatigue levels for both groups from time one (start of second cycle of chemotherapy) to time two (immediately after completing the intervention and start of cycle three of chemotherapy), with these higher levels of fatigue persisting at time three (start of cycle four of chemotherapy or day one of radiotherapy for those participants). The increases between baseline and immediate postintervention fatigue scores were significantly greater for the control group when compared with the intervention group for worst fatigue, average fatigue, fatigue severity, fatigue interference, and FACT-F. These differences were not sustained for changes between baseline and times three or four.

The strength of the study was the inclusion of an attentional control group.

• Effects observed in the study reflected improvements on the subjective measures of fatigue experiences rather than for objective measures of fatigue management behavior. The differences may therefore simply reflect patient expectations that they would benefit from the intervention. 
• Measurement time points may have limited the detection of a difference in the fatigue experienced at times three and four.

Psychoeducational interventions were delivered by experienced oncology nurses. Costs were limited to personnel costs and the one-time costs associated with materials development.

To determine whether a nurse-led educational intervention decreased the perception of fatigue in patients diagnosed with gastrointestinal (GI) cancers who were receiving chemotherapy for the first time and to determine if improvement in fatigue resulted in improvement in quality of life (QOL).

Patients received an individual educational intervention at baseline, on the tenth day after the first cycle of chemotherapy (T1), and 10 days after the second cycle (T2) based on the results of their fatigue assessments. The education program consisted of:  one-to-one education, which consisted of training and counseling about fatigue assessment and management. It was delivered by the researcher. The intervention was designed to improve patients’ knowledge of causes of fatigue and to provide them with strategies to decrease severity, including self-monitoring of fatigue levels, advice on energy conservation, distraction, increasing mobility and activity, stress management, relaxation methods, and management of factors known to cause fatigue.

• In total, 35 patients (57% women) receiving chemotherapy for GI cancer were included.
• Mean age was 49 years (standard deviation = 10.12).
• Patients had GI cancer.
• Of the patients, 91% were married.

• Single site
• Outpatient chemotherapy unit of a large University Hospital in Izmir, Turkey

The study used a descriptive, quasiexperimental design.

• Baseline demographics
• Fatigue and QOL were assessed using the Brief Fatigue Inventory (BFI), Piper Fatigue Scale (PFS), and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
• Instruments were administered before the first cycle of chemotherapy, at T1, and at T2.
• Pre- and posttest analyses were conducted using t-tests.
• Relationships among variables were examined by calculating Pearson correlation coefficients with a statistical significance of p = 0.05.
• Variables included subjective reports of patients’ fatigue and QOL.

Patients’ mean fatigue scores showed a statistically significant decrease, and their EORTC QLQ-C30 scores were better at T1 and T2 compared with baseline.

Nurse-led educational interventions have the potential to reduce fatigue in patients with GI cancers receiving chemotherapy for the first time.

• The exclusion criteria limited the number of patients; the study had a small sample size.
• The sample only included patients with GI cancers in a single center in Turkey.
• No power calculation was performed.
• No control group was used.
• The findings could be culturally specific.
• These limitations prevented generalization. 

The administration of chemotherapy should be preceded by a formal fatigue assessment and the provision of individually tailored educational interventions to reduce the severity of fatigue and improve QOL.

To determine if an internet-based, tailored, psychoeducational program was effective in the management of fatigue and other symptoms for patients with cancer-related fatigue.

Patients were randomly assigned to a tailored, web-based, health navigation program or usual care. The 12-week intervention program covered energy conservation, physical activity, nutrition, sleep hygiene, pain control, and distress management. The program included online education, health advice, message services, caregiver monitoring, and support and educational sessions. Principles of cognitive-behavioral therapy were used in the program design. The program was provided via a health navigation web site. Study measures were obtained at baseline and at the end of 12 weeks. Intention-to-treat (ITT) analysis was performed using the last observation carried forward for missing values.

• In total, 243 patients (23% male, 77% female) were included.    
• Mean age was not provided; 53.5% of the patients were 45 years or older. 
• Multiple tumor sites were included, with 38.6% being breast cancer.
• Slightly greater than 94% of the patients had completed high school or higher education. 
• Global Brief Fatigue Inventory (BFI) scores at baseline were an average of 4.13 across the study groups. 
• At baseline, mean anxiety score was 6.46 and mean depression score was 5.7. 
• All patients had fatigue scores at baseline of 4 or greater for at least one week and had completed primary treatment within the past 24 months.

• Single site 
• Home 
• South Korea

The study was a randomized, controlled trial with a wait-list control.

• BFI
• Health-related quality of life (HRQOL)
• European Organization for Research and Treatment of Cancer Quality of Life Questionnare (EORTC QLQ-C30)
• Hospital Anxiety and Depression Scale (HADS)
• Brief Pain Inventory (BPI)
• Mini Nutritional Assessment (MNA)
• Medical Outcomes Study (MOS) Sleep Scale

The intervention group had a significantly larger reduction in fatigue scores (p = 0.0011), with an effect size of 0.29 (Cohen’s d). The intervention group also had a greater improvement in anxiety score and several quality of life–related scale scores (p < 0.05). Multiple variables were statistically significant predictors of change in fatigue scores.

Health navigation, the psychoeducational intervention used here, had a slight to moderate positive effect in reducing fatigue.

• The study had risks of bias due to no blinding and no appropriate attentional control condition.
• Key sample group differences could have influenced the results.
• Patient withdrawals were 10% or greater. The patient withdrawal rate was 29% overall and 31% in the intervention group.
• At baseline, BFI scores were lower in the intervention group, so the method of ITT analysis may have overestimated the lower fatigue scores at follow-up for this group.
• The withdrawal and loss to follow-up rate in the intervention group suggested that the intervention may not be well received by several patients.

The findings suggested that a psychoeducational program delivered via a web-based program may be helpful for some patients for the management of fatigue. Although the study was limited by a high withdrawal rate in the intervention group, the majority of patients continued with the program. This may be a practical approach that is helpful to some patients. Further research in the area of facilitating and encouraging patient participation in such programs would be useful.

PHASE OF CARE: Late effects and survivorship

Adapted from three guidelines by multidisciplinary experts using supplementary evidence and clinical experience. Most recommendations listed verbatim but some modified to include updated evidence or current practice beliefs.

Recommendations focused on patients who have completed active treatment or are considered in clinical remission. Treat underlying causes, moderate physical activity after cancer treatment with PT and lymphedema referrals as needed (meta-analysis, systematic review, [randomized controlled trial [RCT]; 10 cited), cognitive behavioral therapy (meta-analysis, RCT, systematic reviews; 6 cited), psychoeducational therapies (systematic, RCT; 3 cited), psychosocial services, mindfulness-based interventions (RCT; 3 cited), yoga (RCT; 2 cited), acupuncture (RCT; 2 cited), psychostimulants/wakefulness agents (limited evidence in patients who are post-treatment disease-free). Additional areas in which research needed include biofield therapies, massage, music therapy, relaxation, Reiki, Qigong, ginseng, and vitamin D.

Guidelines were tailored to survivors with current evidence as not all evidence done is survivors.

Screening, assessment, and treatment guidelines summarized for use in cancer survivors.

To ensure that all cancer patients with fatigue were identified and treated promptly and effectively.  These guidelines included recommended standards of care for assessment and management of fatigue in children, adolescents, and adults with cancer.

The guidelines were evidence- and consensus-based. The guidelines were multidisciplinary, and all recommendations were category 2A unless otherwise stated.

The guidelines provided several algorithms for assessment and management based on age group, level of self-reported fatigue, and phase of treatment.

Screening

• All patients with cancer should be screened for the presence or absence of fatigue at regular intervals as a vital sign.
  • Age older than 12 years:  Screen on a 0-to-10 scale or as none, mild, moderate, or severe.
  • Age 7 to 12 years:   Use 1-to-5 scale (1 = no fatigue and 5 = worst).
  • Age 5 to 6 years:  Screen using “tired” or “not tired.”

Focused Evaluation of Fatigue

• A focused history and assessment of contributing factors should be performed when screening indicates moderate to severe fatigue.
  • Age older than 12 years:  score of 4 to 10
  • Age 7 to 12 years:  score of 3 to 5
  • Age 5 to 6 years:  “tired”
• Focused history should
  • Rule out recurrence or progression of cancer
  • Include a review of systems
  • Include an in depth fatigue history, including onset and patterns, associated/alleviating factors, and interference with function.
• Assessment of treatable contributing factors, such as
  • Other related symptoms
  • Anemia
  • Sleep disturbance
  • Medication and side effects
  • Comorbidities
  • Activity and fitness level.

Management and Interventions

• Active Treatment
  • Education and counseling regarding known patterns of fatigue and reassurance that treatment-related fatigue is not necessarily indicative of progression of disease.
  • General management strategies to include self-monitoring, energy conservation techniques, and use of distraction
  • Nonpharmacologic interventions to include activity enhancement, physically based therapies (such as massage), psychosocial interventions, nutritional consultation, and cognitive behavioral therapy for sleep
  • Pharmacologic interventions to include consider psychostimulants, treatment of anemia as indicated, and consideration of mediation for sleep
• Posttreatment
  • Education and counseling about known fatigue patterns and self-monitoring of fatigue levels
  • General management and nonpharmacological and pharmacological interventions as for active treatment above
• End of Life
  • Education and counseling about known fatigue patterns and as an expected end of life symptom
  • General strategies as per active treatment and post treatment
  • Nonpharmacologic interventions to include activity enhancement, psychosocial interventions, and nutrition consultation
  • Pharmacologic interventions as per active and post treatment

Within activity enhancement information, the guideline cites several synthesized reviews regarding the use of exercise and concludes that

• Improvement in fatigue was not noted with all diagnoses.
• It is reasonable to encourage all patients to engage in a moderate level of physical activity during and after cancer treatment.
• Referral to exercise specialists or physical therapy should be triggered by
  • Patients with comorbid conditions, such as chronic obstructive pulmonary disease or cardiac disease
  • Recent major surgery
  • Specific functional or anatomical deficits
  • Substantial deconditioning.
• Exercise should be used with caution in patients with
  • Bone metastases
  • Immunosuppression or neutropenia
  • Thrombocytopenia
  • Anemia
  • Fever or active infection
  • Limitations due to other illnesses.

Because fatigue is a subjective experience, it was recommended that assessment should use patient self-reports and other sources of data.

Several barriers were identified related to effective treatment for fatigue.  Due to barriers, it was stated that screening for fatigue needs to be emphasized.  Rescreening was emphasized because fatigue may exist beyond the period of active treatment.

Factors identified as potential causative agents that should be specifically assessed were outlined.  These factors were pain, emotional distress, sleep disturbance, anemia, nutrition, activity level, medication side effects, and other comorbidities.

It was noted that fatigue often occurs as part of a symptom cluster, often with sleep disturbance, emotional distress, or pain, so that assessment of these problems and institution of effective treatment is essential.

The importance of comprehensive assessment, including review of all current medications and noncancer comorbidities, was identified.  For example, it was noted that there can be thyroid dysfunction after radiation therapy for various cancers or use of biological and that hypogonadism can be associated with fatigue.

• The majority of studies regarding the impact of exercise on fatigue were performed in patients with limited types of cancer, and findings may not be applicable to all types of patients.  In addition, the timing and amount of exercise for various groups are not clear.  There are also few longitudinal studies examining fatigue in long-term disease-free survivors, although fatigue can be a long-term or late effect.
• Although the guideline was structured according to phase of treatment, recommended interventions did not vary according to phase of treatment.  There were minimal differences in recommended content of education and counseling.
• There was little evidence regarding effective management of fatigue in end of life care.
• There was no discussion of prevention related to fatigue.

PHASE OF CARE: Late effects and survivorship

All recommendations were based on lower level evidence and consensus.

Physical activity and memory aids were recommended for cognitive impairment. SSRIs and SNRIs were recommended for depression as first-line treatment, and benzodiazepines were recommended as first-line treatment for anxiety. Physical activity, cognitive behavioral therapy, psychoeducation, and the consideration of psychostimulants were recommended for fatigue.

• Mainly consensus for most recommendations
• Limited database use  
• Full results of search not provided

This guideline gave numerous recommendations and suggestions for various aspects of patient needs. Most recommendations were consensus-based.