Multicomponent Rehabilitative Intervention

Multicomponent Rehabilitative Intervention

PEP Topic 
Fatigue
Description 

Multicomponent rehabilitative intervention may be understood as an interdisciplinary service aimed at ameliorating physical impairments, preventing the development of physical impairments and restrictions in activity and role performance that develop in association with cancer pathology (e.g., muscle weakness, self-care limitations, vocational limitations, disfigurement, speech and swallowing abnormalities, social integration), and preserving and restoring functional capability needed for purposeful activity. Multicomponent rehabilitative intervention encompasses an array of intervention approaches and may include intensive exercise, physical training, sports, psychoeducation, and physical modalities such as massage and manual lymph drainage. Multicomponent rehabilitative intervention has been evaluated in patients with cancer for management of anorexia, anxiety, cognitive impairment, depression, fatigue, lymphedema, and sleep-wake disturbances.

Effectiveness Not Established

Research Evidence Summaries

Cheville, A. L., Girardi, J., Clark, M. M., Rummans, T. A., Pittelkow, T., Brown, P., . . . Gamble, G. (2010). Therapeutic exercise during outpatient radiation therapy for advanced cancer: feasibility and impact on physical well-being. American Journal of Physical Medicine & Rehabilitation, 89, 611–619.

doi: 10.1097/PHM.0b013e3181d3e782
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Study Purpose:

To describe the feasibility of delivering a structured physical therapy (PT) program as part of a multidisciplinary intervention to patients undergoing outpatient radiotherapy for advanced cancer.

Intervention Characteristics/Basic Study Process:

Patients were randomly assigned to receive the structured intervention or standard care using a stratified approach based on Eastern Cooperative Oncology Group (ECOG) performance status, age, sex, and tumor type. The structured multidisciplinary intervention consisted of eight sessions delivered by a PT and a psychiatrist or a psychologist with facilitation provided by an advanced practice nurse, licensed social worker, or certified hospital chaplain depending on the theme. Cognitive, emotional, social, and spiritual dimensions of the intervention centered on specific topics and coping strategies related to patients' goal setting, challenging negative thoughts, communication, and hope. PT sessions incorporated education and provision of printed material, truncal and upper-limb strengthening exercises, and lower-limb strengthening alternating between standing and seated exercises. These were performed with resistance provided by elastic bands. Aerobic conditioning was not included, although patients were encouraged to engage in regular physical activity. Standard care consisted of regular assessment of treatment toxicities. Patients were not counseled regarding the potential benefits of exercise.

This report focused on the PT and interdisciplinary structured intervention aspects of a previously reported study (Rummans et al. 2006).

Sample Characteristics:

  • The study was comprised of 103 patients (59%–69% male) receiving radiotherapy for two weeks or longer who received no more than one treatment at the time of study entry.
  • Age was 59.4–59.7 years. 
  • The highest percentage of patients had gastrointestinal cancer; the sample also included head and neck, lung, brain, and other cancers
  • Of the patients, 59%–63% were also receiving chemotherapy, 78%–89% were married, 32% were fully active performance status, and 55% were currently employed.
  • Patients were included if they had an ECOG performance status of three or greater and had recurrent disease following a six-month disease-free survival.
  • Radiation doses ranged from 3000 to 7200 cGy.

Setting:

  • Single site
  • Mayo Clinic

Study Design:

The study was a single-blind, randomized, controlled trial.

Measurement Instruments/Methods:

  • Spitzer Uniscale used for quality of life (QOL) measurement
  • Linear analog scales (0–10) for self-assessment of physical well-being and fatigue. These scores were subsequently converted to a 100-point scale.
  • Profile of Mood States (POMS) Short Form Vigor and Fatigue subscales
  • 30-minute walk

Results:

  • Six patients were not eligible for analysis due to missing more than four PT sessions.
  • Attendance rates for the entire cohort were 89.3%.
  • Mean scores after approximately one week of the intervention differed significantly between the intervention and control groups only in overall physical well-being (p = 0.02).
  • Changes from baseline were not different between the two groups in any measure at weeks 8 and 27.
  • Approximately half of the intervention group declined functionally despite participation in the structured program.

Conclusions:

The structured intervention appeared to provide short-term improvement in overall perception of well-being; however, this effect was not sustained over the duration of the trial.

Limitations:

  • No commonly used fatigue measures were reported.
  • The authors reported improvement in fatigue; however, the measure was actually patient perception of overall well-being.
  • There was no attentional control group for comparison.
  • The 50% decline in function for patients in the intervention group points to the need to determine which patients might benefit the most from such an intervention and what type of exercise or combined intervention is most effective.
  • The study assessed subjective physical well-being rather than objective performance or the specific phenomenon of fatigue.

Culos-Reed, S. N., Robinson, J. W., Lau, H., Stephenson, L., Keats, M., Norris, S., . . . Faris, P. (2010). Physical activity for men receiving androgen deprivation therapy for prostate cancer: benefits from a 16-week intervention. Supportive Care in Cancer, 18, 591–599.

doi: 10.1007/s00520-009-0694-3
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Study Purpose:

To investigate the effects of a physical activity intervention for men receiving androgen deprivation therapy (ADT) on physical activity behavior, quality of life (QOL), and fitness.

Intervention Characteristics/Basic Study Process:

Patients were randomly assigned to either the intervention or a wait-list control group. Assessments were performed in both groups at baseline, after completion of the 16-week activity intervention, and two and six months postintervention. The exercise program included a home-based portion and weekly group sessions of an individualized program provided by a certified fitness professional. Exercises were tailored to ability but consisted mostly of walking, stretching, and resistance exercises with a Thera-Band. A physioball and Thera-Band were provided to each patient for use in the home-based activity. Home exercise was suggested three to five times per week. Group sessions were conducted weekly for 16 weeks and monthly thereafter until completion of all follow-up measures. These included a group-based workout with individualized feedback, education, and group discussion. Discussion focused on common concerns, goal setting, monitoring behavior, overcoming barriers, role of a positive attitude, social support, relapse prevention, and nutrition.

Sample Characteristics:

  • One hundred patients were randomized, and 66 completed the study.
  • Mean age was 67.6 years (standard deviation = 8.6 years). 
  • Patients had any stage of prostate cancer and were expected to receive ADT for at least six months.
  • Patients with a high risk of osteoporosis were excluded (long-term steroid use or a T-score less than –2.5 on bone mineral densitometry).
  • Of the patients, 88% were married and 61% were retired.
  • Patients were recruited between 2004 and 2006 and had physician clearance to participate in the exercise program.

Setting:

  • Single site
  • Calgary, Canada

Study Design:

The study used a randomized, controlled, repeated measures design.

Measurement Instruments/Methods:

  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
  • Expanded Prostate Cancer Index Composite (EPIC):  This instrument assesses function and bother in three organ systems:  sexual, urinary, and bowel, and has recently expanded to include possible effects of ADT. The test retest reliability and internal consistency is reported to be high for the urinary, bowel, sexual, and hormonal domain summary scores (r ≥ 0.80; α ≥ 0.82).
  • Fatigue Severity Scale (FSS)
  • Center for Epidemiologic Studies Depression scale (CESD)
  • Godins’ leasure score index (LSI) of Godin’s leisure time exercise questionnaire:  a three-item measure assessment of frequency of exercise
  • Fitness assessment, including resting heart rate, blood pressure, six-minute walk, grip dynamometer, and flexibility by testing modified sit and reach
  • Body mass index (BMI)
  • Baseline bone densitometry
  • Variety of bloodwork

Results:

  • Of the patients, 34% dropped out.
  • LSI scores pre- to postintervention showed a significant interaction effect (p = 0.004) with the intervention group reporting increased physical activity and the controls reporting decreased levels.
  • No significant changes were seen in QOL measurements.
  • Of the patients who dropped out, 67% were in the wait-list control group. In the intervention group, 10 patients withdrew; five of these withdrew for medical reasons.
  • Attendance for group sessions was 77.8%, with attendance on average at 12 of 16 sessions.
  • At baseline, both groups had similar BMI measures and were considered in the overweight category. After the program, the intervention group had a very slight decrease in average BMI (change of –0.23), whereas the controls showed an average increase to 29.04 (change of 0.75), just below the level that differentiates overweight from obesity.
  • In the intervention group, there were nonsignificant improvements seen in depression over time; however, the intervention group had a higher level of depression at baseline than the control group.
  • There were no significant changes in fatigue scores over time or between groups.

Conclusions:

The physical activity intervention was associated with an overall increase in reported physical activity. There were no significant effects seen in QOL or fatigue.

Limitations:

  • The high drop-out rate reduced the statistical power of the study, which may have resulted in an inability to detect significant differences between groups.
  • No mechanism was used to evaluate patient adherence to the home-based part of the program.
  • The study lacked an attentional control.
  • There may have been sample selection bias because individuals interested in or already having a more active lifestyle may be more likely to participate in this type of program, so any results seen cannot be attributed to solely to the program.
  • The duration of the intervention may not have been sufficient to see significant changes in the outcome measures.
  • The study demonstrated that maintaining involvement and adherence to exercise in this patient population is challenging.
  • The findings showed that additional studies of the use of exercise in various patient types should continue because effects and issues seen in this study differ somewhat from those in other patient groups.

Dodd, M. J., Cho, M. H., Miaskowski, C., Painter, P. L., Paul, S. M., Cooper, B. A., . . . Bank, K. A. (2010). A randomized controlled trial of home-based exercise for cancer-related fatigue in women during and after chemotherapy with or without radiation therapy. Cancer Nursing, 33, 245–257.

doi: 10.1097/NCC.0b013e3181ddc58c
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Study Purpose:

The primary aim was to evaluate the effectiveness of a home-based exercise training intervention called the Pro-self:  Fatigue Control Program on the management of cancer-related fatigue (CRF). The secondary aim was to study the effects of the intervention on sleep disturbance, depression, and pain.

Intervention Characteristics/Basic Study Process:

Patients were randomized to one of three groups. Two groups received a home-based prescription for exercise called the Pro-self:  Fatigue Control Program (during and after cancer treatment). One of these groups had follow-up. The third group received usual care. All patients completed four valid and reliable tools at baseline, the week before the second chemotherapy treatment, at the end of cancer treatment, and at the end of the study (about one year after the start of the study). The tools measured fatigue, sleep disturbance, depression, and pain and were analyzed to compare how fatigue and other study variables had changed over time and by groups. It was a randomized, single-blind, three-arm, controlled trial design.

Sample Characteristics:

  • The sample was comprised of 119 women.
  • Patients had to be 18 years or older to enroll.
  • Mean age was 50.5 years.
  • Patients had colon (n = 1), ovarian (n = 6), and breast (n = 112) cancer.
  • Patients had a mean education of 16.1 years. 
  • Mean Karnofsky Performance Status (KPS) was 87.63. 
  • A mean of 94 patients were employed.

Setting:

  • Setting Type1:  Multisite
  • Setting Type2:  Outpatient setting
  • San Francisco Bay Area

Study Design:

The study was a randomized, controlled trial (RCT).

Measurement Instruments/Methods:

  • Piper Fatigue Scale (PFS) (α range .96–.97)
  • General Sleep Disturbance Scale (GSDS) (α range .83–.86)
  • Center for Epidemiologic Studies Depression Inventory (CESD) (α range .80–.89)
  • Worst of Pain Intensity Scale
  • KPS
  • Intervention Framework:  Pro-self:  Fatigue Control Program based on self-care and adult learning theory
  • Data Analysis used SPSS version 15, two-tailed tests and multilevel regression analysis. 

Results:

Change in fatigue did not change over time. No significant change in fatigue occurred among groups.

Conclusions:

The home-based exercise intervention had no effect on fatigue or related symptoms associated with cancer treatment. The optimal timing of exercise remains to be determined.

Limitations:

When the study was conducted, the benefits of exercise were being reported in the literature and patients could not be asked to stop their regular exercise. The PFS was administered only three times a year, which might not be frequent enough to capture the true effect of exercise on CRF. The self-report of exercise behaviors was obtained with no objective measures.

Nursing Implications:

CRF is a common problem. Some physical activity is better than none, and there is no harm in exercise as tolerated during cancer treatment. More frequent assessments of fatigue, sleep disturbance, depression, and pain may capture the effect of exercise.

Gagnon, B., Murphy, J., Eades, M., Lemoignan, J., Jelowicki, M., Carney, S., . . . Macdonald, N. (2013). A prospective evaluation of an interdisciplinary nutrition-rehabilitation program for patients with advanced cancer. Current Oncology, 20, 310-318.  

doi: 10.3747/co.20.1612
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Study Purpose:

To evaluate the degree to which a multi-component rehabilitation program improves symptom control and quality of life in patients with advanced cancer

Intervention Characteristics/Basic Study Process:

The intervention was a 10-12 week program offered by a multidisciplinary team, consisting of nutritional counseling, a collaborative care plan based on patient goals, a palliative care physician specialist focused on symptom-related medical interventions, a pivot nurse for care coordination and case management, and an exercise component with semi-weekly exercise sessions with a physical therapist and a home exercise plan. Occupational therapy was provided and focused on self care, leisure, and productivity. Patients were assessed at baseline and during their final clinic visit at the end of the study.

Sample Characteristics:

  • N = 131  
  • MEAN AGE = 59.9 years (SD = 13.0 years)
  • MALES: 50.4%, FEMALES: 49.6%
  • KEY DISEASE CHARACTERISTICS: All had stage III and IV disease with a variety of primary tumor types including both hematologic and sold tumors.
  • OTHER KEY SAMPLE CHARACTERISTICS: 38% were on current chemotherapy; most had ECOG performance status of 1 or 2.

Setting:

SITE: Single site  

SETTING TYPE: Outpatient  

LOCATION: McGill University Cancer Center, Montreal, Canada

Phase of Care and Clinical Applications:

PHASE OF CARE: Late effects and survivorship
 
APPLICATIONS: Palliative care 

Study Design:

Quasi-experimental

Measurement Instruments/Methods:

Edmonton Symptom Assessment Scale (ESAS)
Multidimensional Fatigue Inventory
Distress Thermometer
Coping Thermometer
Six Minute Walk Test

Results:

Change in symptom severity was analyzed and Cohen’s d was used to calculate effect size. Severity of depression from ESAS declined (p <. 0001, d = 0.7); anorexia declined (p < .0001, d = .4);  pain declined (p < .0001, d = .4); physical and general fatigue declined (p < .0001, d = .7); mental fatigue declined (p < .0005, d = .4); and level of distress and difficulty coping declined (p < .0001).

Conclusions:

The multi-component rehabilitation program provided here resulted in a significant improvement in multiple symptoms and a reduction in distress and difficulty coping.

Limitations:

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment) 
  • Risk of bias (no appropriate attentional control condition)  
  • Unintended interventions or applicable interventions not described that would influence results
  • Subject withdrawals ≥ 10%
  • Other limitations/explanation: 30% of patients withdrew from the study–the majority of these were due to death or disease progression. No information is provided about medication changes over the course of the study that might affect outcomes measured. The report states some different results in the body of the article versus tables provided.

Nursing Implications:

A multi-component, multi-disciplinary rehabilitation and palliative care program can provide effective improvement of multiple symptoms in patients with advanced disease.

Gjerset, G. M., Fosså, S. D., Dahl, A. A., Loge, J. H., Ensby, T., & Thorsen, L. (2011). Effects of a 1-week inpatient course including information, physical activity, and group sessions for prostate cancer patients. Journal of Cancer Education, 26, 754–760.

doi: 10.1007/s13187-011-0245-8
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Study Purpose:

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

Intervention Characteristics/Basic Study Process:

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.

Sample Characteristics:

  • 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.

Setting:

  • Single site
  • Inpatient
  • Norway

Phase of Care and Clinical Applications:

Patients were undergoing the active treatment phase of care.

Study Design:

This was a prospective, observational study.

Measurement Instruments/Methods:

  • 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

Results:

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.

Conclusions:

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.

Limitations:

  • 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.

Nursing Implications:

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

Hanna, L. R., Avila, P. F., Meteer, J. D., Nicholas, D. R., & Kaminsky, L. A. (2008). The effects of a comprehensive exercise program on physical function, fatigue, and mood in patients with various types of cancer. Oncology Nursing Forum, 35, 461–469.

doi: 10.1188/08.ONF.461-469
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Study Purpose:

To evaluate the effectiveness of a comprehensive exercise program consisting of low-to-moderate intensity aerobic and resistance exercise twice a week for 16 sessions to assess improvements in physical function, fatigue, and mood.

Intervention Characteristics/Basic Study Process:

Patients received low-to-moderate aerobic and resistance exercise, education, and support twice weekly. At the start of each session, a specialist obtained blood pressure, oxygen saturation, and heart rate for each patient. Patients performed aerobic exercise on a seated machine or treadmill. Progression was obtained through increased exercise duration by adding small increments of three to five minutes per session as tolerated. All patients were able to progress to 40 minutes of aerobic exercise before the end of 16 sessions. Education included various topics focused on symptom management, coping, and wellness, including support groups, survivorship, resources, spirituality, stress management, chemotherapy, radiation, nutrition, energy conservation, relaxation and imagery, drugs and herbs, fatigue and pain, humor therapy, exercise safety and benefits, diagnostic testing, communication issues, financial issues, complementary therapy, and infection control. Average attendance per month was 12 sessions. Support included peer support, exercise environment conducive to discussion within the group, and facilitation of relationships of sharing and encouragement. The specialist inquired about how patients were coping with their disease, side effects, and treatments.

Sample Characteristics:

  • The sample was comprised of 39 patients (77% female) in active treatment and cancer survivors beyond treatment.
  • Patients were older than 18 years. Mean age was 63 years (range 42–87 years; standard deviation = 10.61 years).
  • Patients had 13 different cancer types, with the majority being breast cancer (39%). The most common diagnosed stage was stage III (26%); patients also had stage I (23%), stage II (21%), and stage IV (14%) cancer. One patient had ductal carcinoma in situ (DCIS) of the breast. 
  • Of the patients, 24% stated that exercise was new to them and 30% indicated that exercise was not at all new to them.

Setting:

  • Single site
  • Cancer Center in a 350-bed teaching hospital in east central Indiana

Study Design:

The study was a retrospective analysis of archived data. Patients were eligible if they had a diagnosis of cancer; type and age of diagnosis were not factors.

Measurement Instruments/Methods:

  • Six-minute walk test
  • Profile of Mood States (POMS) Questionnaire to evaluate personal and social integrity
  • Piper Fatigue Scale (PFS) Questionnaire to measure conservation of energy pre- and postprogram
  • The main variables were physical function, fatigue, and mood.

Results:

  • Pre- and postprogram outcome measures had significant differences (p < 0.05). Patients had significant improvements in physical function, fatigue, and mood.
  • Change in fatigue:  On average, patients reported less fatigue on the PFS compared to before the program. Of the sample, 75% improved and 25% stayed the same.
  • The study had a small sample size.
  • No control comparison was used.

Conclusions:

A comprehensive exercise program consisting of low-to-moderate intensity aerobic and resistance exercise, education, and support twice a week for eight weeks resulted in significant improvements in physical function, fatigue, and mood in patients in active treatment and in cancer survivors beyond treatment.

Limitations:

  • The study lacked a control group and uniformity. However, the heterogenicity of the group demonstrated that, regardless of diagnosis and stage, improvements can be achieved.
  • Of the patients, 69% had a break in exercise consistency.
  • Educational sessions were optional, and not all patients attended educational sessions regularly; therefore, the direct role of education on outcome is unknown.

Nursing Implications:

Further studies may need to be conducted comparing the degree of benefit achieved by patients in a comprehensive program versus a single-component exercise or support group program. The study encouraged the use of low-to-moderate intensity exercise to benefit people with all types of cancer. Further studies need to be completed to determine the best mode, duration, and intensity of exercise for survivors. The authors can say with some certainty that low-to moderate intensity exercise produces significant benefits for people with cancer without causing participant overload or drop-out.

Hanssens, S., Luyten, R., Watthy, C., Fontaine, C., Decoster, L., Baillon, C., . . . De Grève, J. (2011). Evaluation of a comprehensive rehabilitation program for post-treatment patients with cancer. Oncology Nursing Forum, 38, E418–E424.

doi: 10.1188/11.ONF.E418-E424
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Study Purpose:

To evaluate the effects of a rehabilitation program on quality of life (QOL), fatigue, fear of movement (kinesiophobia), distress, anxiety, depression, and physical condition.

Intervention Characteristics/Basic Study Process:

The intervention consisted of a 12-week comprehensive rehabilitation program based on Herstel and Balans’s 12-week program. The program combined physical exercise, psychoeducation, and individual counseling. Each component consisted of 

  • Physical training to enhance cardiorespiratory and muscular capacity. Physical training occurred three times a week for 60 minutes and was led by an expert physiotherapist.
  • Psychoeducation to enhance self-confidence, autonomy, and coping skills. Psychoeducation occurred eight times. Each session lasted 90 minutes.
  • Individual counseling to improve patients' follow-up and provide an individualized program. Individual counseling consisted of a 10-minute session at the start of the program, at the beginning of every exercise session, and at the end of the program.

The intervention was provided at no cost to patients.

Sample Characteristics:

  • The sample was comprised of 36 patients (83% female, 17% male).  
  • Mean age was 50 years (standard deviation [SD] = 12 years; range 28–75 years).
  • The majority of patients (n = 27) had breast cancer.
  • Patients had completed all cancer treatments, except long-term hormone treatment. Patients had received diverse treatments (i.e., chemotherapy, radiotherapy, surgery, and biotherapy) before the intervention.
  • Time lapse since the last treatment varied, with a mean of nine months (SD = 14 months; range 0–60 months).
  • Twenty patients were on hormone treatment during the intervention.

 

Setting:

  • Single site
  • Outpatient
  • University hospital in Belgium

Phase of Care and Clinical Applications:

  • Patients were undergoing the transition after initial treatment phase of care.
  • The study has clinical applicability for late effects and survivorship.

Study Design:

The study used a prospective, one-group pre-/posttest design.

Measurement Instruments/Methods:

  • European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30), to measure global QOL and physical functioning and condition
  • Functional Assessment of Cancer Therapy–Fatigue (FACT-F), to measure fatigue
  • Hospital Anxiety and Depression Scale (HADS), to measure depression and anxiety
  • RAND 36-Item Health Survey (RAND-36), to measure general health-related QOL
  • Tampa Scale of Kinesiophobia, to measure fear of movement or injury
  • Distress Barometer, to measure distress
  • Tecumseh Step Test, to measure cardiorespiratory fitness

Results:

  • The authors noted significant improvements in QOL (p < 0.001), physical condition (p = 0.007), fatigue (p = 0.01), and depression (p = 0.012).
  • Kinesiophobia (p = 0.229), distress (p = 0.344), and anxiety (p = 0.101) did not change significantly.
  • In regard to depression, HADS scores changed from 5.71 (SD = 4.7) to 4.13 (SD = 4.36). This change was statistically significant.

Conclusions:

The rehabilitation program was associated with a positive effect on depression, fatigue, and QOL; however, weaknesses in study design may preclude making a definitive conclusion based on the study. Prospective randomized studies must determine the long-term impact and the relative contribution of the program versus spontaneous recovery. Future research should also consider the cost-effectiveness of the rehabilitation program.

Limitations:

  • The small sample size and nature of the sample (i.e., patients with early stage breast cancer) threaten the external validity of the study.
  • The study did not include an appropriate control group. The lack of control group threatens the internal validity of the study. Thus, statistically significant effects may be placebo effects or time effects.
  • The study did not include information regarding the scale and range of scores and method of score computation; therefore, the credibility of analysis based on the scores is unknown.
  • The authors did not report whether patients were clinically depressed and if the improvement in the depression score indicates a clinically significant change.
  • For various reasons, more than half (51%) of the patients who had an intake interview did not participate in the study. This may generate problems associated with the applicability of the program to patients with cancer.

Nursing Implications:

Multidisciplinary rehabilitation can be one way to manage depression and fatigue in patients with cancer.

Heim, M.E., v d Malsburg, M.L., & Niklas, A. (2007). Randomized controlled trial of a structured training program in breast cancer patients with tumor-related chronic fatigue. Onkologie, 30, 429–434.

doi: 10.1159/000104097
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Intervention Characteristics/Basic Study Process:

Intervention consisted of physiotherapy, group exercises, and psycho-oncologic interventions. Patients received a brochure with instructions for nine muscle strength and nine stretching exercises for large muscle groups. Outcomes were assessed at baseline, start of intervention (T1), end of intervention (T2), and at a three-month follow-up (T3).

Sample Characteristics:

  • N = 63
  • AGE: In the intervention group, 56% were aged 51–70 years
  • KEY DISEASE CHARACTERISTICS: Patients with breast cancer with cancer-related chronic fatigue
  • OTHER KEY SAMPLE CHARACTERISTICS: Control group patients were slightly younger, but otherwise both groups were well balanced. Intervention group: 56% married, 59% working, most patients had received chemotherapy (66%) and radiation therapy (81%), and 78% received hormonal therapy
  • EXCLUSION CRITERIA: Evidence of psychiatric disease or patients who were less than six weeks to preceding surgery or chemotherapy

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Active treatment, inpatient rehabilitation

Study Design:

  • Randomized controlled trial
    • Structured physical training intervention (N = 32)
    • Control (N = 31)

Measurement Instruments/Methods:

  • Linear analogue scale (LASA)
  • Multidimensional Fatigue Inventory (MFI)
  • Functional Assessment of Cancer Treatment (FACT)

Results:

Trial outcome index for fatigue in the FACT-F questionnaire showed improvement in fatigue from T1–T3. The interaction of time and group were statistically significant (p = 0.003). For MFI measures, interaction between group and time effects was significant for physical fatigue between T2–T3 (p = 0.028). The mean MFI total score was higher for both the control and intervention group in comparison to the mean MFI total score for healthy women in the age group of 40–50 years at the three-month follow-up.

Limitations:

  • Small sample size

Nursing Implications:

Future research should incorporate better measures for the intensity of the exercise.

Korstjens, I., Mesters, I., van der Peet, E., Gijsen, B., & van den Borne, B. (2006). Quality of life of cancer survivors after physical and psychosocial rehabilitation. European Journal of Cancer Prevention, 15, 541–547.

doi: 10.1097/01.cej.0000220625.77857.95
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Intervention Characteristics/Basic Study Process:

This was a twelve-week outpatient rehabilitation program combining physical exercise and psycho-education and delivered in a group setting (12–16 participants per group). Physical training was led by two physiotherapists for two hours twice a week. Sessions aims included improving movement skills, improving strength and endurance, coping with fatigue, enhancing feelings of control, and reducing stress. Each session consisted of individual strength and endurance training (one hour) or a group sports activity (one hour), paired with 30 minutes of aqua aerobics. Each session of the group sports activity had a central theme (i.e., capability and cooperation, coordination, throwing and catching, social contact, winning and losing, relaxation). Psychoeducation sessions were led by oncology health professionals and aimed at providing support in coping with cancer and enhancing self-confidence and autonomy. Participants were provided with information on cancer-related subjects and encouraged to share their experiences as cancer survivors. Patient outcomes were assessed at baseline, week 6, and week 12.

Sample Characteristics:

  • N = 658
  • MEAN AGE =50.6 years
  • AGE RANGE = 18–75 years
  • FEMALES: 77.8%
  • KEY DISEASE CHARACTERISTICS: Participants with mixed solid tumors and hematologic malignancies. Approximately 50% of the sample had the diagnosis of breast cancer.
  • OTHER KEY SAMPLE CHARACTERISTICS: The majority was married or lived together (77.7%), most had children (76.9%), about half were employed at the time of diagnosis (48.3%). At the start of rehabilitation, only one-fifth (15.8%) was actually at work. The sample was a mean of 1.3 years from the conclusion of treatment, with a range of 0–14 years following treatment.
  • EXCLUSION CRITERIA: Physically at risk owing to cancer or serious comorbidity, serious cognitive disturbances, restricting side effects of medication, or if needing more complex rehabilitation

Study Design:

  • Longitudinal single-arm cohort design
    • No comparison group

Measurement Instruments/Methods:

  • EORTC QLQ-C30

Results:

After six weeks, participants in the intervention group experienced a significant decline in fatigue (p < 0.001) in comparison to baseline measurements. After 12 weeks, participants experienced an even greater decline in fatigue (p < 0.0001) in comparison to baseline measurements.

Limitations:

  • Unable to determine the benefits of exercise and psychoeducation components of intervention separately
  • Lack of a neutral comparison group; therefore, unable to determine whether improvements in quality of life were a direct result of the rehabilitative program
  • Long-term effects were not assessed in the study

Nursing Implications:

Future research should incorporate objective physical strength and endurance tests and validated measurement instruments for more specific psychosocial parameters.

Kroz, M., Fink, M., Reif, M., Grobbecker, S., Zerm, R., Quetz, M., . . . Gutenbrunner, C. (2013). Multimodal therapy concept and aerobic training in breast cancer patients with chronic cancer-related fatigue. Integrative Cancer Therapies, 12, 301–311.

doi:10.1177/1534735412464552
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Study Purpose:

To investigate the feasibility and effects of a multimodal intervention for fatigue compared to home-based aerobic exercise

Intervention Characteristics/Basic Study Process:

Individuals selected which intervention they wanted—home exercise or the multimodal intervention. The multimodal intervention included psychoeducation, including mindfulness-based techniques, sleep education regarding sleep hygiene, restriction and stimulus control, eurythmy therapy involving mind-body exercises, and medicine-oriented painting therapy. Those in the exercise group were asked to carry out 30-minute sessions three to five times weekly. Those in the multimodal group had 225 minutes of activity once weekly over 10 weeks, led by specialists in that therapy. Baseline and follow-up study measures were obtained within three weeks prior to starting the study and within three weeks after completion.

Sample Characteristics:

  • N = 28 
  • MEAN AGE = 57 years
  • MALES: 0.5%, FEMALES: 99.5%
  • KEY DISEASE CHARACTERISTICS: All had breast cancer. On average, patients were three years out from initial diagnosis and treatment.
  • OTHER KEY SAMPLE CHARACTERISTICS: Approximately half were employed. All had a fatigue score of at least four and had fatigue for at least six months.

Setting:

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

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Late effects and survivorship

Study Design:

  • Observational two-group pilot study

Measurement Instruments/Methods:

  • Cancer Fatigue Scale (CFS-D) (scale of affective, physical, and cognitive fatigue)
  • Pittsburgh Sleep Quality Index (PSQI)
  • Satisfaction with intervention on five-point Likert scale

Results:

Those in the multimodal group showed a significant reduction in physical fatigue (p = .0342, mean change = -2.1). Those in the multimodal group had a significant improvement in global sleep quality (p = .041, mean change = -2.0).

Conclusions:

A multicomponent intervention was seen to be feasible and had a positive impact on rating of physical fatigue and global sleep quality.

Limitations:

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Risk of bias (no appropriate attentional control condition)
  • Other limitations/explanation: Adherence to home-based exercise is not known.

Nursing Implications:

A holistic multicomponent approach to manage patient fatigue and sleep disruption may have greater benefit than interventions that only incorporate exercise. Further research is needed to determine what type and intervention components are most effective.

Lindemalm, C., Strang, P., & Lekander, M. (2005). Support group for cancer patients. Does it improve their physical and psychological wellbeing? A pilot study. Supportive Care in Cancer, 13, 652–657.

doi: 10.1007/s00520-005-0785-8
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Intervention Characteristics/Basic Study Process:

A 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 of Grahn (1993). During the intervention period, patients 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.

Sample Characteristics:

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

Setting:

The intervention venue was a residential rehabilitation setting selected specifically to deliver the intervention.

Phase of Care and Clinical Applications:

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

Study Design:

The study was uncontrolled—fatigue was evaluated immediately after the first six-day intervention, with follow-up at 3, 6, and 12 months postintervention.

Measurement Instruments/Methods:

Norwegian fatigue questionnaire—an 11-item measure with two factors:  physical fatigue and mental fatigue. The total score is created by totaling the 11 items.

Results:

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 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 noted at the 6- and 12-month postintervention time points.

Limitations:

  • The study lacked a control group.
  • The sample size was not justified by power analysis; it is 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 and recruitment was offered.
  • Generalization of the study results is limited by the primarily female sample and the overrepresentation among patients of breast and gynecologic malignancies.
  • Costs of residential group treatment were unexplored.

Nursing Implications:

The program requires the involvement of several skilled professionals.

Pinto, B. M., Papandonatos, G. D., Goldstein, M. G., Marcus, B. H., & Farrell, N. (2013). Home-based physical activity intervention for colorectal cancer survivors. Psycho-Oncology, 22, 54–64.

doi: 10.1002/pon.2047
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Study Purpose:

To test the hypothesis that a home-based exercise intervention would improve fitness and physical activity and to determine the intervention effects on fatigue, self-reported physical functioning, and quality of life (QOL).

Intervention Characteristics/Basic Study Process:

Those randomized to the exercise program received in-person instructions on how to exercise at a moderate intensity level, monitoring heart rate and how to warm-up and cool-down with exercise. Patients in the exercise group were asked to keep activity logs and were encouraged to exercise at least 10 minutes two days per week, increasing to 30 minutes per day, at least five days per week. Each received a weekly telephone call for the 12-week study to identify problems and reinforce participation, using cognitive-behavioral processes of change tailored to each patient. Patients in the control condition received weekly calls for 12 weeks for the administration of a symptom questionnaire and problem monitoring. Patients then received monthly telephone calls for three months. Telephone calls were audiotaped, and 25% of the tapes were reviewed for content to ensure fidelity to the study protocol. Study measures were obtained at baseline and at 3, 6, and 12 months.

Sample Characteristics:

  • The sample was comprised of 46 patients (56.5% female, 43.5% male). 
  • Mean age was 55.6 years (standard deviation [SD] = 8.24 years) in the control group and 59.5 years (SD = 11.2 years) in the exercise group. 
  • All patients had colorectal cancer, with an average of three years since diagnosis.
  • All patients had undergone surgery, and most did not receive radiation or chemotherapy treatment. 
  • A majority of the patients had attended college and had a median income of greater than $60,000.

Setting:

  • Single site
  • Home
  • Rhode Island

Phase of Care and Clinical Applications:

Patients were undergoing multiple phases of care.

Study Design:

The study was a randomized, controlled trial.

Measurement Instruments/Methods:

  • Seven-day Physical Activity Recall (7-day PAR)
  • Treadwalk maximal fitness test
  • Community Health Activities Model Program for Seniors (CHAMPS) questionnaire
  • Functional Assessment of Cancer Therapy–Fatigue and Colorectal subscales (FACT-F and FACT-C)
  • Short Form 36 (SF-36) physical functioning subscale

Results:

Both groups showed improvement in fitness and physical functioning over time, as well as increased physical activity. The exercise group showed a greater increase in physical activity at three months, but there was no difference from the control group at 6 or 12 months. During the first three months, the exercise group also showed significant improvement from baseline in CHAMPS energy expenditure and motivational readiness; however, these effects declined after three months. The intervention group demonstrated better submaximal aerobic fitness than the control group at all time points (p < 0.02). There were no significant intervention effects on fatigue, physical functioning, or QOL. These outcomes improved in all patients, and these improvements were sustained throughout the 12 months of follow-up. The authors speculated that the lack of apparent impact on fatigue may be associated with the fact that patients were highly functioning, although their baseline fatigue levels were lower than those seen in other studies in which exercise was effective.

Conclusions:

The home-based exercise program improved patients’ physical activity, motivation, and fitness; however, it did not demonstrate an impact on fatigue or QOL. Activity and motivation were most improved during the first three months, when they received weekly telephone calls, suggesting that frequent contact may have been important in these results.

Limitations:

  • The study had a small sample size, wth less than 100 patients.
  • No information was provided regarding patient adherence to the recommended exercise program from patient logs.
  • The lack of differences in CHAMPS between groups suggests that their actual activity levels were not substantially different.
  • The majority of patients were highly educated and in a higher socioeconomic status and almost 100% were white, suggesting that these findings may not be applicable to other types of patients.

Nursing Implications:

The findings suggest that a home-based exercise program can improve physical activity and aerobic fitness, but it did not appear that these improvements translated into reduced fatigue. Further research in the area of exercise and fatigue are needed to determine if exercise may be most effective in patients with greater fatigue at baseline.

Rabin, C., Pinto, B., Dunsiger, S., Nash, J., & Trask, P. (2009). Exercise and relaxation intervention for breast cancer survivors: feasibility, acceptability and effects. Psycho-Oncology, 18, 258–266.

doi: 10.1002/pon.1341
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Study Purpose:

To assess the feasibility, acceptability, and preliminary effects of a 12-week combined physical activity and relaxation intervention for breast cancer survivors.

Intervention Characteristics/Basic Study Process:

Participants met with an intervention coordinator to complete baseline questionnaires and an activity assessment. They were then provided with exercise education about types of exercise and stretches, using a pedometer, setting activity goals, progressive muscle relaxation, and how to record these activities. Participants were then called weekly for 12 weeks during the intervention to provide further counseling.

Sample Characteristics:

  • The sample was comprised of 19 women.
  • Mean age was 52.5 years.
  • Participants had breast cancer stage 0 to II.
  • Participants had completed cancer therapy and were considered sedentary (moderate activity less than twice weekly or vigorous activity less than once weekly).
  • Of the participants, 95.7% were white.

Setting:

  • Multisite
  • Oncology clinics

Phase of Care and Clinical Applications:

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

Study Design:

The study used a pre-/post design.

Measurement Instruments/Methods:

  • Intervention feasibility was assessed using single-item, 1-to-5 scale, not a standard instrument.
  • Seven-day Physical Activity Recall (7-day PAR)
  • The Stage of Motivational Readiness for Physical Activity
  • IM Systems–three accelerometers (objective measure of physical activity) 
  • Profile of Mood States (POMS)
  • Pittsburgh Sleep Quality Index (PSQI)

Results:

Fatigue was statistically reduced from baseline to weeks 12 (p < 0.05) and 24 (p < 0.01). Sleep quality was also improved from baseline to weeks 12 (p < 0.01) and 24 (p < 0.05).

Conclusions:

Participants found the intervention feasible without interrupting their levels of physical activity. Fatigue and sleep quality were improved significantly from baseline, suggesting a benefit from physical activity and relaxation as a combined practice. Further research is needed with control groups.

Limitations:

  • The study lacked an appropriate control group.
  • The study had a small sample size, with less than 30 participants.

Nursing Implications:

Behavioral interventions for breast cancer survivors are a feasible and safe practice and may improve quality of life in participants. These interventions can be taught by nurses to patients.

Spahn, G., Choi, K.E., Kennemann, C., Ludtke, R., Franken, U., Langhorst, J., . . . Dobos, G.J. (2013). Can a multimodal mind-body program enhance the treatment effects of physical activity in breast cancer survivors with chronic tumor-associated fatigue? A randomized controlled trial. Integrative Cancer Therapies, 12, 291–300. 

doi: 10.1177/1534735413492727
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Study Purpose:

To evaluate a multimodal mind-body program (MMMT) compared to walking effect on fatigue in women with stage I–IIIA breast cancer

Intervention Characteristics/Basic Study Process:

Participants in the intervention group underwent six hours of training in meditation, whole-food cooking, naturopathic strategies, and mindfulness by a multidisciplinary team. A sports therapist supervised a walking program in weeks 1, 3, and 10. Participants were encouraged to walk at home three times per week for 30 minutes. Participants in the control group also underwent a sports therapist-supervised walking program in weeks 1, 3, and 10. They also were encouraged to walk at home three times per week for 30 minutes.

Sample Characteristics:

  • N = 55   
  • AGE: Control mean: 55.3 years; MMMT mean: 58.1 years
  • MALES: 0%, FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Average time first diagnosis: 39.7 months control, 61.9 months MMMT; stage I disease: 48% control, 30% MMMT; stage II disease: 44% control, 56.7% MMMT; stage IIIA disease: 0% control, 6.7% MMMT
  • OTHER KEY SAMPLE CHARACTERISTICS: 20% smokers in MMMT group, 0 in control; mean fatigue in last month: MMMT 6.5, control 6.7

Setting:

  • SITE: Single site 
  • SETTING TYPE: Outpatient 
  • LOCATION: University of Duisburg-Essen, Germany

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Late effects and survivorship

Study Design:

  • RCT

Measurement Instruments/Methods:

  • German Fatigue Assessment Questionnaire with visual analog scale
  • European Organization for Research and Treatment of Cancer EORTC QLQ-30
  • Multidimensional Fatigue Inventory (MFI)
  • Hospital Anxiety and Depression Scale (HADS)
  • Menopausal Rating Scale

Results:

Unusual fatigue in the last week and last month was improved in both groups with no group differences. Anxiety in the MMMT group was improved compared to the control group (p = .043) during treatment but was not maintained in follow-up (p = .422). Both groups showed overall anxiety improvement. Reported pain between groups was improved in MMMT at follow-up compared to control (p = .031).  Menopausal symptoms decreased in both groups. No significant side effects were seen.

Conclusions:

A home-based exercise program showed improvement in reported fatigue. The addition of a mind-body component showed no additional benefit.

Limitations:

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Unintended interventions or applicable interventions not described that would influence results
  • Key sample group differences that could influence results
  • Questionable protocol fidelity
  • Subject withdrawals ≥ 10%

Nursing Implications:

Home-based exercise is a reasonable and safe option for patients experiencing cancer-related fatigue.

Strauss-Blasche, G., Gnad, E., Ekmekcioglu, C., Hladschik, B., & Marktl, W. (2005). Combined inpatient rehabilitation and spa therapy for breast cancer patients: effects on quality of life and CA 15-3. Cancer Nursing, 28, 390–398.

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Intervention Characteristics/Basic Study Process:

The three-week inpatient rehabilitation included exercise, manual lymph drainage, and massage; some patients also received group counseling, progressive muscle relaxation, and balneotherapy (carbon dioxide bath and mud therapy). The aim of carbon dioxide baths is to increase peripheral blood flow while mud packs increase tissue temperature. Measures were obtained two weeks preadmission, at the end of treatment, and six months later.

Sample Characteristics:

  • The sample was comprised of 149 women with breast cancer who were 3 to 72 months postsurgery.
  • Mean age was 57 years (standard deviation = 10.5 years; range 32–82 years).
  • Of the patients, 70% had lymphedema.

Setting:

Rehabilitation center and spa in Austria

Study Design:

The study used a pre-/posttest design.

Measurement Instruments/Methods:

  • European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) 
  • Hospital Anxiety and Depression Scale (HADS)
  • CA15-3 tumor markers
  • German Illness-Coping Questionnaire

Results:

Patients received a median of 61 treatments. Of the patients, 22% dropped out at follow-up. There was a significant decrease in fatigue (p < 0.001) from pre- to posttest (effect size [ES] = .38) and pretest to six-month follow-up (ES = .38).

Conclusions:

Fatigue improvement was greater for those with greater lymphedema.

Limitations:

  • The study lacked a control group.
  • The measure of fatigue was limited.
  • The study was very heterogeneous in terms of type of treatment and time since treatment.
  • No data were provided regarding cost or whether service was free.

van Weert, E., Hoekstra-Weebers, J., Otter, R., Postema, K., Sanderman, R., & van der Schans, C. (2006). Cancer-related fatigue: predictors and effects of rehabilitation. Oncologist, 11, 184–196.

doi: 10.1634/theoncologist.11-2-184
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Intervention Characteristics/Basic Study Process:

The 15-week, multidimensional rehabilitation program included aerobic bicycle training plus general muscle force training, supervised sports sessions, psychoeducational sessions, and informational classes.

Sample Characteristics:

  • The sample was comprised of 72 patients (85% female) who were posttreatment.
  • Mean age was 51.4 years (standard deviation = 9.6 years).
  • Of the patients, 61% were women with breast cancer.
  • Patients were included if they
    • Were 18 years or older
    • Had their last cancer treatment greater than three months previously
    • Had an estimated life expectancy of one year or greater 
    • Had an indication for rehabilitation.

Setting:

  • Outpatient
  • Center for Rehabilitation in The Netherlands

Study Design:

The study used a pre-/posttest design with measures before and after completion of the program. No control group was used.

Measurement Instruments/Methods:

  • Multidimensional Fatigue Inventory (MFI)
  • Rotterdam Symptom Checklist (RSCL)
  • Exercise capacity and muscle force
  • Short Form 36 Health Survey (SF-36)

Results:

  • Of the patients, 77.8% completed the program and were posttest drop-outs.
  • Drop-outs had more recurrences.
  • There was significant improvement in every dimension of the MFI.
  • The greatest effect was on physical fatigue.
  • Effect sizes ranged from –0.35 to –0.78.
  • There were no differences based on time since treatment.

Limitations:

  • The intervention was delivered by an interdisciplinary team, including physical therapists and a psychosocial specialist.
  • The role of nursing is unclear and atheoretical.
  • Consequences were used as predictors.
  • There was no control for overlap in the tools.
  • It is not possible to determine which aspects of the intervention were effective.

van Weert, E., May, A. M., Korstjens, I., Post, W. J., van der Schans, C. P., van den Borne, B., Mesters, I., . . . Hoekstra-Weebers, J. E. (2010). Cancer-related fatigue and rehabilitation: a randomized controlled multicenter trial comparing physical training combined with cognitive-behavioral therapy with physical training only and with no intervention. Physical Therapy, 90, 1413–1425.

doi: 10.2522/ptj.20090212
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Study Purpose:

To determine the effect of a combined rehabilitation program (physical training [PT] and cognitive-behavioral training [CBT]) and PT alone on cancer-related fatigue (CRF) compared with a control group receiving no intervention.

Intervention Characteristics/Basic Study Process:

Two groups of cancer survivors were randomly assigned to 12 weeks of PT or to 12 weeks of PT plus CBT. The control group was not randomized. PT included aerobic training combined with progressive resistance exercise (twice weekly for two hours). CBT included self-management skills based on problem-solving (once weekly for two hours). In the analysis, fatigue scores were also compared to a general Dutch population of similar age.

Sample Characteristics:

  • The sample was comprised of 147 patients (44% male, 56% female).   
  • Mean age was 46 years.
  • Breast cancer was predominant in all three groups.
  • Patients were cancer survivors one to two years posttreatment.

Setting:

  • Multisite  
  • Four rehabilitation centers in The Netherlands

Study Design:

The study was a randomized, controlled trial.

Measurement Instruments/Methods:

Multidimensional Fatigue Inventory (MFI) was used preintervention (Cronbach α range 0.73–0.83) and postintervention (Cronbach α range 0.84–0.88) to measure five domains:  general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue.

Results:

Levels of fatigue significantly decreased in all domains in all groups (p < 0.05; effect size across domains range –0.38 to –1.36), except in mental fatigue in the control group. No significant differences were found in decline of fatigue between the intervention groups. Patients completed 82.4% of PT and CBT sessions and 83.5% of PT sessions. In the post hoc analysis, patients with lower educational levels reported less decline in physical fatigue, reduced motivation, and reduced activation.

Conclusions:

PT combined with CBT was equally effective in reducing fatigue, suggesting that CBT had no benefit beyond PT. Patients in the control group also showed a significant decline in fatigue, suggesting that time alone is also effective related to fatigue reduction.

Limitations:

  • The study lacked an appropriate control group.
  • There was an overrepresentation of patients with breast cancer.
  • The study lacked a group receiving CBT only.
  • The study duration was limited (12 weeks). 

Nursing Implications:

The study supported the effectiveness of PT in the treatment of CRF.

Wangnum, K., Thanarojanawanich, T., Chinwatanachai, K., Jamprasert, L., Maleehuan, O., & Janthakun, V. (2013). Impact of the multidisciplinary education program in self-care on fatigue in lung cancer patients receiving chemotherapy. Journal of the Medical Association of Thailand = Chotmaihet Thangphaet, 96, 1601–1608.

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Study Purpose:

To examine the effects of a multidisciplinary intervention on fatigue

Intervention Characteristics/Basic Study Process:

The intervention group received training in individual sessions at week one, three, and six. A physical therapist provided education in deep breathing and designed a program of physical exercises to do at home. A nutritionist assessed needs and educated patients in nutrition during therapy. A nurse met with the patient, providing general psychoeducational intervention. All specialists had sessions with the patient at all study time points.

Sample Characteristics:

  • N = 60   
  • MEAN AGE = 56.1 years
  • AGE RANGE: 45–65 years
  • MALES: 68.3%, FEMALES: 31.7%
  • KEY DISEASE CHARACTERISTICS: Lung cancer, undergoing chemotherapy
  • OTHER KEY SAMPLE CHARACTERISTICS: Fatigue, pain, and peripheral neuropathy were the most frequent symptoms at baseline.

Setting:

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

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Active antitumor treatment

Study Design:

  • RCT

Measurement Instruments/Methods:

  • Piper Fatigue Scale

Results:

At the end of the study, the trial group had a lower fatigue score than controls (p = .036).

Conclusions:

A multidisciplinary intervention to promote self-care may reduce symptoms of fatigue.

Limitations:

  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Other limitations/explanation: No information about patients' actual practice of exercise and other recommendations is provided. No baseline fatigue levels are provided.

Nursing Implications:

Education provided by a multidisciplinary group may be beneficial and positively impact fatigue during cancer therapy.

Windsor, P. M., Potter, J., McAdam, K., & McCowan, C. (2009). Evaluation of a fatigue initiative: information on exercise for patients receiving cancer treatment. Clinical Oncology, 21, 473–482.

doi: 10.1016/j.clon.2009.01.009
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Study Purpose:

For patients to evaluate the usefulness of the information provided.

Intervention Characteristics/Basic Study Process:

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 together with advice on starting aerobic walking exercise during treatment. Patients were also encouraged to attend workshops on fatigue management as listed on flyers included in the folder. Materials included home exercise information, walking information, and a guide for good sleep.

Sample Characteristics:

  • The sample was comprised of 146 patients (90 women and 115 men). 
  • Mean age was 63.4 years.
  • Patients had genitourinary (n = 119), gynecologic (n = 37), breast (n = 46), and other (n = 3) cancers.
  • The study included four treatment groups:  radical radiotherapy, postoperative radiotherapy, palliative radiotherapy, and chemotherapy.

Setting:

  • Single site
  • United Kingdom

Study Design:

This was an observational cohort study.

Measurement Instruments/Methods:

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

Results:

Overall, patients reported an increase in fatigue from baseline to the end of cancer treatment and from baseline to the first follow-up visit. 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 cancers other than breast (p = 0.018), and were not receiving chemotherapy (p < 0.05) reported lower fatigue scores on the BFI. Ten patients participated in a fatigue workshop.

Conclusions:

The 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 are associated with the level of fatigue experienced. The findings suggest that the provision of written educational/informational materials can be helpful in encouraging patients to exercise.

Limitations:

  • The study lacked an appropriate control group.
  • Time intervals varied between baseline and end of treatment for those receiving palliative radiotherapy (one to two weeks), radical or postoperative radiotherapy (four weeks), and chemotherapy (four months). Workshops were held in palliative care centers.

Nursing Implications:

Fatigue did not decrease in any group. The study demonstrated the importance of providing information on fatigue and 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.

Systematic Review/Meta-Analysis

de Nijs, E. J., Ros, W., & Grijpdonck, M. H. (2008). Nursing intervention for fatigue during the treatment for cancer. Cancer Nursing, 31, 191–208.

doi: 10.1097/01.NCC.0000305721.98518.7c
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Purpose:

To conduct a systematic review to identify which nursing interventions are used to reduce fatigue caused by cancer treatment and to identify the level of evidence for those interventions.

Search Strategy:

Databases searched were PubMed and CINAHL (1995–February 2005).

Search keywords were cancer, cancer treatment, chemotherapy, distraction, education, exercise, fatigue, nursing intervention, radiotherapy, and sleep promotion.

Studies were included in the review if 

  • The intervention was performed by nurses
  • The study was conducted by nurses
  • The intervention was performed with adults
  • The intervention was performed during cancer treatment.

Literature Evaluated:

An initial search was performed to find systematic reviews. No reviews of studies meeting the inclusion criteria were found. A second search to locate intervention studies yielded 192 studies in CINAHL and 78 in PubMed. Screening for inclusion criteria resulted in the identification of 18 studies that were then included in the review. Ten studies reported the effects of exercise, five reported education and counseling, two reported distraction and relaxation, and one reported sleep promotion.

Sample Characteristics:

The sample was comprised of 904 patients across 18 studies.

Results:

Exercise Studies

  • Sample sizes varied from 22 to 119 patients.
  • Kind of exercise varied from a seated video exercise program to an aerobic program at home or in a supervised clinic.
  • Intensity of exercise varied.
  • Patient adherence to exercise programs was a problem, and not all studies accounted for this factor.
  • Only five studies divided patients into exercisers and nonexercisers based on usual activity. 
  • Five studies demonstrated significant effects in the intervention group.
  • One qualitative study was found in which fatigue changed from a negative to a positive experience with exercise, and patients experienced increased physical activity and increased level of energy.

Education and Counseling

  • Three studies were randomized, controlled trials (RCTs), one used a pre-/posttest design, and one was longitudinal.
  • Information was provided on tape, by telephone, or in person.
  • Information was given in 3 to 10 sessions and included information about other symptoms in addition to fatigue in four out of the five studies.
  • In two studies, fatigue increased with the intervention, and in three studies, a decrease was found in the experimental group.
  • Talking to someone was an important aspect, a trend associated with group interaction was found, and one study found a significant effect over time.

Distraction and Relaxation

  • One RCT used relaxation breathing every day for six weeks in patients who received stem cell transplantation. The intervention group experienced significantly less fatigue.
  • One crossover design study used virtual reality during intravenous chemotherapy treatment. There was a significant effect, but the posttest was performed immediately after treatment.

Sleep Promotion

  • One study used a pre-/posttest design using an individualized sleep promotion plan. No significant effects were found.

Conclusions:

Sleep promotion was identified as a promising intervention despite the single study results because other studies have shown a relationship between fatigue and sleep disorders. More research is warranted in this area. Lack of effect seen with education and counseling studies may be due to small sample sizes, lack of equivalent control groups, and lack of sensitivity in fatigue measurement. It is also possible that education alone is not enough to change patient behavior. Exercise is shown to be effective, but nothing is known about the long-term effects of exercise after treatment and whether exercise can prevent the beginning of fatigue. Adherence to exercise programs is an area that requires attention. No data were available regarding the level of activity prior to cancer treatment, which might influence the findings in this area.

Limitations:

  • None of the studies used a theoretical framework, likely explained by the fact that no satisfactory theory has been formulated to explain fatigue in this population. Some studies did not even use a definition of fatigue.
  • Fatigue was measured differently, and three different measures were used.
  • In two-thirds of the studies, the sample was breast cancer patients receiving chemotherapy, limiting the external validity of the findings.
  • Half of the studies had very small sample sizes of less than 30 patients.
  • Study of distraction and relaxation was limited by the timing of fatigue measurement.
  • No long-term effects or ongoing intervention was studied.

Nursing Implications:

There are several promising interventions that can be provided by nurses. It is likely that a combination of interventions may be most helpful for patients. More research is specifically needed on the effects of interventions that enhance the quality of sleep, education, and counseling related to fatigue management and prevention.

Egan, M.Y., McEwen, S., Sikora, L., Chasen, M., Fitch, M., & Eldred, S. (2013). Rehabilitation following cancer treatment. Disability and Rehabilitation, 35, 2245–2258.

doi: 10.3109/09638288.2013.774441
Print

Purpose:

STUDY PURPOSE: To summarize evidence regarding rehabilitation interventions to address problems of cancer survivors

TYPE OF STUDY: Systematic review

Search Strategy:

DATABASES USED: PubMed, EMBASE, CINAHL, Scopus, Google Scholar

INCLUSION CRITERIA: Effectiveness of treatment that could be provided by rehab professionals, subjects 18 years or older, cancer survivors (defined as having completed primary treatment). Reports on only systematic reviews and RCTs, though these were not identified as criteria.  

EXCLUSION CRITERIA: Pharmaceutical, surgical, or radiological interventions

Literature Evaluated:

TOTAL REFERENCES RETRIEVED: Not stated

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: No quality rating applied. Appears to have very few studies in multiple areas.

Sample Characteristics:

  • FINAL NUMBER STUDIES INCLUDED =  56
  • SAMPLE RANGE ACROSS STUDIES, TOTAL PATIENTS INCLUDED IN REVIEW: Not provided
  • KEY SAMPLE CHARACTERISTICS: Not provided

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Transition phase after active treatment

Results:

  • Reviews seven systematic reviews and six RCTs regarding impact of exercise on fatigue
  • States that results confirm a positive effect on fatigue for rehab therapies
  • Some of these studies included acupuncture, counseling, and mindfulness-based stress reduction therapy

Conclusions:

Evidence supports the effectiveness of exercise-based interventions in managing fatigue among cancer survivors.

Limitations:

  • No quality rating of studies
  • Limited studies included, and it is not clear how these were selected
  • Study findings are grouped by problem, rather than synthesizing evidence related to specific interventions (for example, combining effects of exercise and acupuncture interventions)

Nursing Implications:

The review provides limited information to assess efficacy of specific interventions. Studies reviewed here do not add further to the body of knowledge overall, and the report is aimed at identifying interventions that can be provided by rehabilitation professionals rather than synthesis of intervention evidence.

Scott, D.A., Mills, M., Black, A., Cantwell, M., Campbell, A., Cardwell, C.R., . . . Donnelly, M. (2013). Multidimensional rehabilitation programmes for adult cancer survivors. The Cochrane Database of Systematic Reviews, 3, CD007730. 

doi: 10.1002/14651858.CD007730.pub2
Print

Purpose:

STUDY PURPOSE: To conduct a systematic review of studies examining the impact of multidimensional rehab programs

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy:

DATABASES USED: MEDLINE, EMBASE, CINAHL through February 2012, Cochrane Register of Controlled Trials (CENTRAL)

KEYWORDS: Extensive listing of search terms per database is provided.

INCLUSION CRITERIA: RCT or quasi RCT, interventions included a physical and psychological component, sample is adults who have completed cancer treatment, at least two treatments of the intervention were provided

EXCLUSION CRITERIA: Not specified

Literature Evaluated:

TOTAL REFERENCES RETRIEVED: 25,824

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Used a checklist of study characteristics for risk of bias. Nine studies had insufficient information to evaluate risk of bias.

Sample Characteristics:

  • FINAL NUMBER STUDIES INCLUDED = 12 (6 studies that used the SF36 for outcome measures were included in meta-analysis)
  • SAMPLE RANGE ACROSS STUDIES: 24–543
  • TOTAL PATIENTS INCLUDED IN REVIEW = 1,669
  • KEY SAMPLE CHARACTERISTICS: Prostate and breast cancer were most prevalent patient types. One study involved head and neck, and four studies included multiple cancer types.

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Late effects and survivorship

Results:

Two studies showed no benefit of the intervention, seven showed benefit in one domain, and three reported significant improvement in physical and psychosocial domains. Three studies specifically reported fatigue outcomes with combinations of CBT or psychoeducational and exercise interventions. All of these had moderate-to-high risk of bias. Duration of interventions that was longer than 12 weeks showed no additional improvement over interventions delivered up to 12 weeks. Interventions delivered face-to-face appeared to be more effective, and additional telephone follow-up “boosters" improved results. Meta-analysis of physical and mental components of SF36 measures showed no statistically significant overall effect of the intervention. The nature, timing, and duration of interventions varied substantially across studies.

Conclusions:

There is insufficient evidence to assess the efficacy of multidimensional rehab programs to improve fatigue in individuals with cancer. Programs with a single focus may be more successful in improving outcomes that are the focus of the intervention. Face-to-face delivery with follow-up boosters appear to be most effective.  Beneficial effects seen appear to plateau after about six months.

Limitations:

Meta-analysis was possible on only a few studies. Few studies used objective measures of physical component outcomes. Program adherence by patients was not often reported in studies.

Nursing Implications:

Findings here do not show sufficient evidence to fully evaluate the effectiveness of multidimensional rehab programs to improve fatigue or physical and psychological outcomes for cancer survivors. Such programs may have short-term benefit for some patients, and it appears that interventions delivered face-to-face with follow-up may be more effective.


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