Psychoeducation/Psychoeducational Interventions

STUDY PURPOSE: To determine the effects of nonpharmacologic interventions on sleep quality in patients with lung cancer

TYPE OF STUDY: Meta-analysis and systematic review

DATABASES USED: Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, WHO International Clinical Trials Registry Platform Search Portal and Clinical Trials.gov

YEARS INCLUDED: Open start date through December 2016

INCLUSION CRITERIA: Nonpharmacologic intervention studies of any design for patients with lung cancer at any stage or illness and at any point in treatment, compromising at least 25% of participants who used sleep disturbance or quality as primary or secondary outcome by subjective or objective measure

EXCLUSION CRITERIA: None noted

TOTAL REFERENCES RETRIEVED: N = 1,259 

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two authors reviewed all studies for eligibility, and disagreements were resolved through discussion and third author as needed.

FINAL NUMBER STUDIES INCLUDED: N = 22

TOTAL PATIENTS INCLUDED IN REVIEW: 1,272

SAMPLE RANGE ACROSS STUDIES: ≤ 10 = 3 studies, > 10 < 100 = 16 studies , ≥ 100 = 3 studies 

KEY SAMPLE CHARACTERISTICS: 82.4% of participants had lung cancer, > 66% had stage III or IV illness and were undergoing treatment.

PHASE OF CARE: Multiple phases of care

Interventions were grouped into 3 categories. Standard exercise and rehabilitation programs showed statistically significant improvements in sleep outcome measures in the short-term follow-up period (SMD -0.43, 95% CI; -0.68, -0.19, p = 0.0005). No differences were seen at the medium- and longer-term follow-up periods. Information, psychoeducation, and symptom screening interventions showed significant differences when compared to control at short-term follow up but was not measured at a later interval (SMD: -0.87, 95% CI, -1.21, -0.54, p, 0.00001). Mind-body interventions (2 studies with n < 100) showed large effect in treating sleep disturbances in patients with lung cancer in the short-term follow-up period (SMD: -0.88, 95% CI, -1.59, -0.16, p = 0.02), which were not observed at the medium follow-up period.

Although the three groups of interventions, exercise, information, psychoeducation, and mind-body interventions appear to improve sleep disturbances in the short term following the interventions, the data quality is low. The series of 22 studies looks at multiple interventions per category, some with small sample sizes, and uses a variety of delivery methods. Based on individual assessments and results of studies in other cancer populations, nurses may want to recommend the interventions to patients with lung cancer, at least to try. However, the call for ongoing research in the area continues, with specific focus on larger sample sizes, specific disease states, and single interventions.

• Mostly low quality/high risk of bias studies
• High heterogeneity
• Low sample sizes

The data for recommending use of nonpharmacologic interventions for sleep disturbances in patients with lung cancer are not sufficient. It is clear that they are feasible and may be effective in some instances. It does appear that they may improve sleep disturbance in the short term, but further work is needed to conduct larger studies and examine individual interventions and their components, as well as the treatment phase for the patient in which the intervention in applied. Based on assessment of patient condition and desire, nurses can use their judgment to make recommendations for patients with lung cancer to try nonpharmacologic interventions to improve sleep.

To test the effectiveness of a six-week, web-based, multiple health behavior change program called Surviving and Thriving With Cancer (STC) for adult cancer survivors

STC was a six-week online patient education course with modules on nutrition, changes in body, sleep, and other side effects associated with cancer treatment recovery. Nine online cohorts consisted of 20–25 survivors. Sessions had 30–35 webpages of material geared toward skills building with specific content to build self-efficacy. Each week, users identified a health behavior to change and were guided to set realistic, achievable goals. Action plans were posted in a discussion center where two trained cancer survivor facilitators provided feedback and help. Participants were prompted at the middle and end of the week via an automated message to update progress and give feedback to other participants. The website contained components called \"Discussion Center,\" \"My Tools,\" \"Post Office,\" and \"Help.\" The discussion center facilitated social networking through four threaded bulletin boards: action planning, problem solving, difficult emotions, and celebrations. Randomization occurred by groups of 40–50 participants after the completion of baseline a questionnaire. Half were assigned to treatment and half to a wait-list control group. Data collection occurred at baseline and after six months during follow-up.

• N = 352  
• MEAN AGE = 49.3 years (control); 52.4 years (intervention)
• MALES: 16% (control); 20% (intervention), FEMALES: 84% (control); 80% (intervention)
• KEY DISEASE CHARACTERISTICS: Adult cancer survivors recruited online, though referrals, or by mailings; 18 years of age or older; after completion of primary cancer treatment at least four weeks prior but not more than five years before joining the study; diagnosis with only one cancer and no recurrence; access to the Internet; ability to read English
• OTHER KEY SAMPLE CHARACTERISTICS: 85%–89% Caucasian; 83%–84% breast cancer (early stage); majority were healthy; highly educated and well-adjusted

• SITE: Multi-site
• SETTING TYPE: Other
• LOCATION: Recruited from oncology clinics, a tumor registry, and online mechanisms such as Facebook and the Association of Cancer Online Resources

• PHASE OF CARE: Late effects and survivorship

Randomized, controlled, delayed-treatment design

• Demographic and clinical information
• Brief Fatigue Inventory (BFI)
• Women’s Health Initiative Insomnia Rating Scale (WHIIRS)
• Godin Exercise Questionnaire
• The Block Food Frequency Questionnaire (number of servings of fruits and vegetables per week)
• Patient Health Questionnaire (PHQ-8)

In total, 303 survivors completed the follow-up survey (six months after completion of the baseline survey), and participants in the intervention arm reported significantly greater reductions in insomnia and greater increases in minutes per week of vigorous exercise and stretching compared to patients in the control arm. Compared to the control group, the intervention group experienced an improvement in insomnia from baseline to six months 9.6–9.2 versus 9.6–10.1 (p = 0.03). There were no significant changes in fruit and vegetable consumption or other outcomes.

The intervention affected insomnia and exercise; however, the majority of the sample met or exceeded national recommendations for health behaviors and were not suffering from depression or fatigue at baseline. Participants’ ability to make substantial health behavior changes may have been limited.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (sample characteristics)
• Measurement validity/reliability questionable
• Findings not generalizable
• Subject withdrawals ≥ 10%
• Other limitations/explanation: Roughly 14% of participants who were randomized did not provide any data at six months (but groups did not differ). Sixty percent of the interested participants were highly educated and were recruited from online social networking sites, suggesting that participants were active on the Internet. Therefore, the sample characteristics may bias the results. Overall, the participants were healthy and well-adjusted with little to no need for significant changes in their health behaviors. The majority of participants were Caucasian (87.2%) and female (82.1%), limiting generalizability. A significant difference in age was found among the treatment and wait-list groups. The mean number of sessions logged on at least once was 5.3 (SD = 1.28, range = 0–6), and 67% of participants attended all six sessions, which may have affected the outcomes. Health behaviors were self-reported, and there may have been over- and underestimation of exercise and fruit and vegetable intake because of social desirability or recall bias. The significance level was not adjusted for the multiple comparisons of numerous outcomes.

Web-based interventions are relevant for people who are not near facilities that could offer face-to-face interventions. Health behavior change interventions are relevant for cancer survivors, so continuing to test and refine interventions is imperative in the area of cancer survivorship.

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 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.

This was an educational intervention on the side effects of radiation therapy (RT) for prostate cancer; a four-minute followed by an eight-minute tape-recorded message (informational intervention versus standard of care information) was used at treatment 1, and a different message was used at treatment 5. The outcome was the severity of the side effects from RT.

• The sample was comprised of 152 patients receiving RT for curative, localized, prostate cancer.
• Mean age was 70.8 years.
• Of the patients, 96% were Caucasian.
• Of the patients, 13% were in stage A, 66% were in stage B, and 21% were in stage C.

• Eight cancer centers
• Eastern United States

Patients were undergoing the active treatment phase of care.

The study was a randomized, controlled trial.

A single-item measure of sleep was obtained at week 2 and the end of treatment.

A brief educational intervention is helpful in reducing sleep problems resulting from RT and cancer.

• Baseline symptom severity was not measured.
• Cost is incurred when developing the tape-recorded messages.

No training is required.

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 evaluate the feasibility of a patient-controlled, cognitive-behavioral intervention for pain, fatigue, and sleep disturbance during treatment for advanced cancer and to assess the initial efficacy of the intervention.

Patients provided baseline measures, such as measures relating to demographics and a symptom inventory, received education, and underwent training to use an mp3 player loaded with 12 cognitive-behavioral strategies (relaxation exercises, guided imagery, nature sounds). Patients used the strategies as needed for symptom management for two weeks and kept a log of symptom ratings with each use. Following the two-week intervention, patients completed a second symptom inventory and an evaluation of the intervention. Clinic staff identified patients who met the eligibility criteria based on diagnosis and treatment and then were briefly introduced to the study and asked if a research nurse could visit to provide additional information. The research nurse met with interested patients, assessed symptoms, and completed eligibility screening. Study purpose and procedures were explained, and written informed consent was obtained.

• The sample was comprised of 30 patients (20% male, 80% female).
• Mean age was 56.27 years (range 36–79).
• All patients had advanced (recurrent or metastatic) cancer and were receiving chemotherapy or radiotherapy. Half of the patients had a diagnosis of gynecologic cancer. Patients had been diagnosed with lung cancer (n = 8), colorectal cancer (n = 6), and prostate cancer (n = 1).
• Most patients were Caucasian, women, and had earned a bachelor’s degree or higher.
• Almost all patients (n = 27) were taking two or more prescribed supportive medications to treat symptoms.
• Studies were included if they included at least two of the following three symptoms:  pain rated 3 or higher on a 0-to-10 scale in the previous 48 hours, fatigue in the previous week, and sleep disturbance in the previous week. 
• Studies were excluded if they involved postoperative or neuropathic pain.

• Multisite
• Outpatient
• Midwestern United States
   

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

The study used a one-group, pre- and postintervention design.

• Demographic questionnaire and chart review form to record age, gender, education, race, ethnicity, cancer diagnosis, current treatments, and supportive medications prescribed, such as analgesics, steroids, psychostimulants, hypnotics, or sedatives
• Symptom inventory, to measure
  • Pain severity, by means of four, 0-to-10 numeric rating scales for pain now, worst pain, least pain, and average pain in the last 24 hours
  • Fatigue severity, by means of four, 0-to-10 scales for fatigue now, worst fatigue, least fatigue, and average fatigue in the last 24 hours
  • Sleep disturbance, by means of a 0-to-10 scale rating sleep disturbance in the last 24 hours and, from the Pittsburgh Sleep Quality Index (PSQI), a verbal rating of sleep quality
• Additional symptoms and their effects on daily functioning, as assessed by the MD Anderson Symptom Inventory (MDASI), which includes items measuring 13 common cancer-related symptoms and their effect on general activity, mood, work, relations with others, walking, and enjoyment of life
• Treatment log book, in which patients tracked each time they used a cognitive-behavioral strategy. Data tracked were time of day; strategy used; and immediate pre- and posttreatment scores, on a 0-to-10 scale, regarding severity of pain, fatigue, and sleep disturbance
• Poststudy evaluation, a 12-item survey created, for the current study, to assess patients’ perceptions of the acceptability of the study procedures. Among the items evaluated were time commitment; equipment; and questionnaires and factors relating to the patient-controlled, cognitive-behavioral intervention, such as length, variety, and usefulness.
   

• Symptom scores at two weeks did not differ significantly from baseline scores; however, significant reductions in pain, fatigue, and sleep disturbance severity were found in ratings made immediately before and after the use of a cognitive-behavioral strategy.
• Mean pain scores decreased from 4.54 pretreatment to 2.77 posttreatment.
• Mean fatigue scores decreased from 4.9 pretreatment to 3.44 posttreatment.
• Average sleep disturbance scores decreased from 5.05 pretreatment to 2.81 posttreatment.

The patient-controlled, cognitive-behavioral intervention is feasible and may reduce the day-to-day severity of co-occurring pain, fatigue, and sleep disturbance.

• The study had a small sample size, with less than 100 patients.
• The study had a risk of bias due to no control group.
• The study used a convenience sample comprised of well-educated, primarily female patients—a sample that may not be representative of all populations.
• Uncontrolled extraneous variables, such as supportive medication use, could have influenced symptom outcomes.

The findings support nurse education and the recommendation of the specified patient-controlled, cognitive-behavioral interventions for the management of pain, fatigue, and sleep disturbance. In regard to patient care and symptom management at all stages of cancer, nurses are the front-line educators of patients. This intervention supports the principle of autonomy for patients able to participate actively in care. Further study—a randomized, controlled trial to test the efficacy of the intervention for co-occurring pain, fatigue, and sleep disturbance—was under way at the time this study was published.

To examine the effect of a planned educational program on symptom control

Patients were randomly assigned to the education or waitlist control/usual care group. The educational intervention consisted of face-to-face educational sessions prior to each chemotherapy cycle provided to patients, caregivers, and family members. Symptom management education, support, and opportunity for discussion were provided.

• N = 140   
• MEAN AGE = 58.9 years
• MALES: 45%, FEMALES: 55%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: All had hematologic cancers and were beginning initial chemotherapy.
• OTHER KEY SAMPLE CHARACTERISTICS: Sixty-four percent were married, and 22% had no more than primary education.

• SITE: Single-site   
• SETTING TYPE: Outpatient    
• LOCATION: Turkey

PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial

Not specified

The prevalence of chemotherapy-induced nausea and vomiting and difficulty sleeping were significantly lower after the intervention in the education group (p < 0.001), whereas the prevalence of these symptoms increased in the control group.

The findings suggest that an educational intervention can be beneficial in managing symptoms related to cancer treatment.

• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Method of randomization not described
• How symptom data were measured/obtained is unclear.

Patient education may be helpful in managing symptoms during cancer treatment. Education is necessary but may not be sufficient for symptom control.

The purpose was to evaluate the effects of psychological counseling and sleep adjuvant measures on postoperative qualify of life and sleep in patients undergoing an esophagectomy.

Four groups were included: (a) psychological counseling plus sleep measures during the intensive care unit (ICU) stay, (b) psychological counseling alone, (c) sleep adjuvant measures alone during the ICU stay, or (d) standard care. Psychological interventions were performed by a psychologist in four or more sessions during the hospital stay according to a cognitive-interactive model. Sleep adjuvant measures included being in a quiet corner of the ICU provided earplugs and eye masks. Patients were instructed on the use of each but were free to use them as needed. Nurses concentrated their routine assessment when possible.

• N = 74; 16, 19, 19, and 20 in each group   
• AGE: 61–67 years (average). Range was 51–75.
• MALES/FEMALES: Given in ratios 15:1, 17:2, 15:4, and 16:4  (male:female)  
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Patients undergoing esophagectomy for resectable esophageal cancer

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Site: ICU, Setting: Hospital, Location: Italy

PHASE OF CARE: Active antitumor treatment

Randomized four-group trial

EORTC C30, PSQI

Psychological counseling reduced the decline in quality of life (odds ratio [OR] 0.23) and sleep quality (OR 0.27). The study was stopped early because of changes in the ICU setting.

Psychological counseling was beneficial in reducing the decline in quality of life and sleep impairment following esophagectomy. This is a labor-intense intervention, and consideration of the nursing factors in the sleep adjuvant measures is important.

• Small sample (< 100)
• Other limitations/explanation: The study was stopped early. It is not known how closely patients followed the sleep adjuvant measures.

Following esophagectomy, patients are at high risk of quality-of-life impairments and sleep problems. This study identified benefits to psychological counseling as well as adjuvant sleep measures. The sleep measures could be incorporated into clinical care for any surgical patient and show promise to impact sleep problems. Additional research is warranted.

This multimodal psychological sleep management program combined relaxation techniques (progressive muscle relaxation [PMR] or autogenic training [AT]; sleep hygiene; cognitive techniques; and advice) in stimulus control techniques. Outcomes were sleep and quality of life (QOL).

• Of the patients, 80 were in the PMR group, 71 were in the AT group, and 78 were in the control group.
• The study included a mixed sample of adults, with a mean age of 58 years, who predominantly had breast, kidney, or prostate cancer.

• Three to four weeks’ length of stay in an oncology rehabilitation clinic
• Germany

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

The study used a quasiexperimental design, with sequential recruitment of groups and patient choice for PMR or AT.

Pittsburgh Sleep Quality Index (PSQI), German Translation

No statistically significant difference was found between the PMR and AT groups. Improvement was noted in the intervention groups regarding sleep latency, sleep duration, sleep efficiency, sleep medication (decreased), and daytime dysfunction.

• Use of a validated tool validity of German translation was not addressed.
• The study was not randomized.
• Staff must be trained in AT, PMR, and other intervention techniques.

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 Nucare program was a short-term psychoeducational coping strategies intervention. Three delivery formats were offered:  (1) small group, (2) one-to-one, and (3) a home format with didactic material. The didactic material comprised a workbook, cassette or CD containing spoken instruction to guide the individual through the workbook, and music to accompany the relaxation training component. Outcomes were quality of life (QOL) and depressive symptoms.

• The sample was comprised of 101 patients.
• Patients were included if they had head and neck primary cancer, were up to 36 months following diagnosis, had finished their cancer treatment, and were able to understand and complete the study questionnaires.

Outpatient oncology clinic at the Jewish General Hospital Montreal, Canada

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

This was a feasibility study with a prospective, nonrandomized design, two groups, and repeated measures at baseline and three and four months.

• European Organisation for Research and Treatment of Cancer Core QOL Questionnaire (EORTC QLQ-C30) to measure health-related QOL
• Hospital Anxiety and Depression Scale (HADS) to measure depression and anxiety

Compared with their baseline scores, the intervention group had improved physical and social functioning, global QOL, fatigue, sleep disturbance, and depressive symptoms. The control group showed no changes in QOL or depressive symptoms.

• The sample was a convenience one, and a significant number of people refused to participate, thereby reducing generalizibility.
• Sample size was not based on any calculation or hypothesis; rather, it was determined by logistical and financial constraints, so some differences may have been missed owing to insufficient power.
• Loss to follow-up was greater in the test group than in the control group.

A 20-minute audiotape was used that included education about the self-care behaviors of exercise and relaxation to manage anxiety, fatigue, and sleep problems. A self-care diary mirrored the audiotape. The control group received education about side effects. Outcomes were fatigue, anxiety, and sleep.

• The sample was comprised of 71 patients.
• Mean age was 50.4 years (range 30–74).
• Of the patients, 85% had stage I or II breast cancer and were receiving chemotherapy regimens with cyclophosphamide.

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

Patients were undergoing the active treatment phase of care.

The study was a randomized, controlled trial.

A modified self-care diary measured the number of side effects, severity of each side effect, number of self-care behaviors performed for each side effect, and the effectiveness of each self-care behavior.

More women in the control group reported difficulty sleeping at baseline; both groups experienced increased severity of sleep disturbance between the first and second self-care diary.

• Control was lacking regarding how much and what kind of information was given to women at the time of treatment. The use of the self-care audiotapes may have been insufficient.
• The trial had a small sample size.

• PHASE OF CARE: Multiple phases of care

The AGREE II and Cochrane Risk of Bias tool were used for evaluation of articles. Three practice guidelines and 12 RCTs were evaluated, and 27 supplemental supportive documents were reviewed (e.g., reviews, information summaries, consensus statements, best practice advice), which were not always cancer-focused. Results are summarized briefly with modest overall quality found in the practice guidelines and RCTs. Considerations were made for small samples, short follow-up in effectiveness trials, and lack of details on methods. Formal assessments were not conducted on supplemental articles to fill in missing gaps of knowledge.

The guideline recommends, at minimum, a brief and focused assessment for sleep disturbances in patients with cancer and cancer survivors and provides options for screening tools and self-report assessments. Strategies, algorithms for screening, assessment, and management are provided based on literature, but they also are consensus-driven. The screening should include a short two-step process using standardized tools. The focused assessment then should identify chronicity and severity of the sleep problems (parameters of symptoms of poor sleep included). This includes key questions and a sleep diary for full evaluation. Referrals for noninsomnia-related disorders (e.g., apnea, restless legs syndrome) are prompted within the algorithm. Based on the initial evaluation, nonpharmacologic and pharmacologic interventions are recommended in a step process with care pathways that match the severity of the sleep disturbance (i.e., mild, transient, insomnia syndrome) with three corresponding care pathways. Preventative and supportive educational information is provided for all patients with cancer and cancer survivors that focuses on sleep hygiene and other sleep-promoting strategies. Rationale is provided for each strategy of treatment within this algorithm.

• The guideline addresses sleep disturbances within the context of an insomnia syndrome.
• All other disorders requiring referral are not within the scope of the proposed guidelines.
• Menopause-related sleep disturbances are not addressed.
• The use of the guideline would necessitate training of healthcare providers to fully incorporate into practice. 

A basic and focused screening for sleep problems in patients with cancer is needed, with corresponding treatment and education as pertained to the scope of practice.