Likely to Be Effective

Exercise

for Sleep-Wake Disturbances

Exercise is physical activity that involves repetitive bodily movement done to improve or maintain one or more of the components of physical fitness: cardiorespiratory endurance (aerobic fitness), muscular strength, muscular endurance, flexibility, and body composition. Exercise interventions in patients with cancer have been provided as home-based, patient self-managed programs as well as supervised and unsupervised individual or group exercise sessions of varying duration and frequency. They can include combinations of aerobic and resistance activities. Exercise has been studied in patients with cancer for anxiety, chemotherapy-induced nausea and vomiting, depression, dyspnea, hot flashes, lymphedema, sleep/wake disturbance, pain, and fatigue. It has also been studied for caregiver strain and burden. Users of this information are encouraged to review intervention details in study summaries, as the exercise interventions studied and their timings in the trajectory of cancer care vary and these differences can influence effectiveness.

Systematic Review/Meta-Analysis

Chiu, H.Y., Huang, H.C., Chen, P.Y., Hou, W.H., & Tsai, P.S. (2015). Walking improves sleep in individuals with cancer: A meta-analysis of randomized, controlled trials. Oncology Nursing Forum, 42, E54–E62.

Purpose

STUDY PURPOSE: To evaluate the effectiveness of walking exercise on sleep-wake disturbances in patients with cancer
 
TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: EMBASE, PubMed, Web of Science, PsycINFO, CINAHL, and Cochrane Database of Systematic Reviews
 
KEYWORDS: Sleep or sleep disturbance, insomnia, cancer, home-based walking exercise, or walking exercise
 
INCLUSION CRITERIA: Studies with self-reported sleep outcomes using validated scales; exercise used was walking; adult patients; designs included control or alternative treatment group 
 
EXCLUSION CRITERIA: Not specified

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 132
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: The investigator developed a method to evaluate randomization, allocation concealment, incomplete outcome reporting and selective reporting.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 9
  • TOTAL PATIENTS INCLUDED IN REVIEW = 599
  • SAMPLE RANGE ACROSS STUDIES: Not provided

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Results

Overall, the effect size for walking on sleep disturbance was -0.52 (Hedges' g: 95%; CI -0.79, -0.25). There was significant overall heterogeneity among the studies. Multiple subgroup analyses were conducted to explore factors that may contribute to the heterogeneity. The effect size was not associated with age, gender, the duration of the intervention, or adherence rate. An analysis demonstrated no evidence of publication bias. Studies were done before, during, or after treatment for cancer, and the overall effect sizes did not differ according to the timing of the intervention. All studies used walking of moderate intensity, and most studies were done in women with breast cancer. Some studies included additional exercise interventions such as strength training, and some also included psychoeducational interventions.

Conclusions

Walking exercise appears to improve sleep in patients with cancer.

Limitations

There was a relatively small number of studies included with high heterogeneity. Twelve studies were excluded because they did not report sufficient data to compute an effect size or they did not use a self-reported sleep outcome. These excluded studies, which have been summarized in other PEP® summaries, did not demonstrate the effectiveness of exercise. This suggests that effectiveness may be overestimated in this analysis.

Nursing Implications

This analysis provides some support for moderate intensity walking exercise to improve sleep. The findings need to be viewed with caution because of the high heterogeneity of the studies and the contrary findings that were excluded from this analysis. However, walking is a safe activity for patients, and it can be suggested to patients as an approach that may improve sleep. It also could be incorporated into multicomponent approaches to address sleep-wake disturbances.

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Langford, D. J., Lee, K., & Miaskowski, C. (2012). Sleep disturbance interventions in oncology patients and family caregivers: a comprehensive review and meta-analysis. Sleep Medicine Reviews, 16, 397–414.

Purpose

To synthesize findings from intervention studies for sleep disturbance in patients with cancer and their caregivers.

Search Strategy

Databases searched were PubMed, CINAHL, and PsycINFO.

Search keywords were sleep, sleep disturbance, insomnia, intervention, cancer, oncology, and caregivers.

Studies dated through 2010 that evaluated sleep disturbance/sleep quality as the primary or secondary outcome were included.

Literature Evaluated

  • The total number of references retrieved was not stated.
  • The method of study evaluation was described for the type of intervention, mode of delivery, dose, and duration but not for study quality.
  • There were only two studies that affected caregivers.

Sample Characteristics

  • The final number of studies included was 49 (47 targeting patients and 2 targeting caregivers). 
  • Thirteen studies were included in the meta-analysis (total of 1,202 patients with cancer). 
  • The total sample across all studies was 3,205 patients.
  • The sample range across studies was 9 to 276 patients (including patients with cancer).
  • Patients had various cancer types, phases of treatment, and stages of disease. 
  • Women with breast cancer were studied most commonly.

Results

Intervention groupings analyzed via meta-analysis included cognitive-behavioral therapy (CBT), education, exercise, and complementary and alternative therapies. Effect sizes appeared to be slightly over 1.0 for CBT, close to 0 for education, slightly over 1.0 for exercise, and slightly over 0 for complementary and alternative therapies. Specific effect sizes were only shown graphically, and actual data were not presented. No separate analysis of caregiver effects could be determined. Modes of delivery of interventions varied widely across studies.

Conclusions

Findings suggest at least moderate effects of CBT and exercise for improvement in sleep disturbances for patients with cancer. No substantial effects of exercise and education were demonstrated.

Limitations

The review was limited by the lack of any data regarding heterogeneity in the meta-analysis, variability of interventions, and modes of delivery to enable any firm conclusions.

Nursing Implications

Insufficient evidence was provided to draw any conclusions regarding intervention effects for caregivers.

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Mercier, J., Savard, J., & Bernard, P. (2016). Exercise interventions to improve sleep in cancer patients: A systematic review and meta-analysis. Sleep Medicine Reviews. Advance online publication. 

Purpose

STUDY PURPOSE: To summarize the available evidence regarding the extent to which exercise improves sleep in patients with cancer

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: PbuMed, EMBASE, PsycINFO, SportDiscus, Cochrane Library
 
INCLUSION CRITERIA: Randomized, controlled trial or nonrandomized trial; adult patients with nonmetastatic disease; comparing exercise to usual care or an alternative intervention; English or French language
 
EXCLUSION CRITERIA: Yoga interventions

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 243
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Risk of bias was evaluated. Most studies had low risk of bias, although a few had small sample sizes and less than half reported exercise program adherence.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 21
  • TOTAL PATIENTS INCLUDED IN REVIEW = 2,077
  • SAMPLE RANGE ACROSS STUDIES: 23-301
  • KEY SAMPLE CHARACTERISTICS: Sample mean ages ranged from 47-64 years. Varied tumor types were included. Breast cancer was most prevalent. Four studies had a quasiexperimental design.

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Results

Sleep outcomes improved in 10 studies (47.6%). Interventions included home-based programs, supervised exercise, or a combination of these two approaches. Aerobic and resistance exercise were employed individually or in combination. Meta-analysis of 12 randomized, controlled trials showed no significant effect of interventions compared to control groups.

Conclusions

Analysis showed no clear significant effects of exercise interventions on sleep outcomes among patients with cancer.

Nursing Implications

Evidence from this analysis does not show an effect of exercise interventions on sleep quality. However, a large body of evidence regarding numerous other benefits of exercise for people with cancer exists. The analysis and most research have included patients who do not necessarily have clinical insomnia, so it would not be expected that interventions would improve sleep. Future research needs to be conducted among patients with clinically relevant insomnia.

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Mishra, S.I., Scherer, R.W., Geigle, P.M., Berlanstein, D.R., Topaloglu, O., Gotay, C.C., & Snyder, C. (2012). Exercise interventions on health-related quality of life for cancer survivors. Cochrane Database of Systematic Reviews, 8, CD007566.

Purpose

To conduct a meta-analysis of the effectiveness of exercise interventions on health-related quality of life (HRQoL) and domains (e.g., physical, psychological, economic, social, and spiritual well-being) of HRQoL among adult cancer survivors posttreatment.

Search Strategy

Databases searched were Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, MEDLINE, EMBASE, CINAHL, PsycINFO, PEDro, LILACS, SIGLE, SPORTDiscus, OTSeeker, Sociological Abstracts, Web of Science, and Scopus.

Search keywords (selected from appendices) were exercise, quality of life, health-related quality of life, pain, and cancer.

Studies were included in the review if they

  • Were randomized, controlled trials (RCTs) and controlled clinical trials that compared exercise interventions with either usual care or no exercise
  • Evaluated the impact on overall HRQoL or at least one domain of HRQoL in cancer survivors posttreatment
  • Reported cancer survivors diagnosed as adults (18 years and older).

Studies were excluded if they reported patients with terminal cancer or in hospice care who were receiving active treatment for primary or recurrent cancer.

Literature Evaluated

A total of 1,795 relevant references were retrieved.  A total of 1,636 articles were excluded based on the title and abstract.  After further review of the abstract, 82 were excluded because they did not meet the inclusion criteria. An additional 13 were excluded from qualitative synthesis because they were ongoing studies.

Sample Characteristics

  • The review included a final number of 40 trials in qualitative synthesis and 33 in quantitative (meta-analysis of findings).
  • A total of 3,694 participants were randomized to an exercise (n = 1,927) or control (n = 1,764) group.
  • Of the 40 studies, 38 were RCTs, three used variation of an RCT, and two used a quasiexperimental design. All but four trials were randomized to an exercise group or a control group.
  • Studies included various cancer types, including breast, colorectal, head and neck, and others. Twenty-two trials were focused on breast cancer only.
  • The time frame included 30 studies completed with treatment and 10 completed during and after cancer treatment. Only posttreatment data were included. The range of treatment time was immediate completion of treatment to up to 15 years after completion.
  • The majority of trials reported females only; 15 used mixed gender samples.
  • Participant age ranged from 39 to 68 years.
  • Of those reporting socioeconomic status, the majority of participants had at least a high school education.
  • Fifteen trials reported past exercise use, with types of exercise including strength and resistance training, walking, cycling, yoga, qigong, and tai chi.

Phase of Care and Clinical Applications

The review has clinical applicability for late effects and survivorship.

Results

Exercise had a positive effect on change in HRQoL scores at 12 weeks and six months of evaluation, and it improved cancer-specific HRQoL in breast cancer concerns. The effect on HRQoL remained after exclusion of patients who were receiving active treatment. For cancer-specific HRQoL, there was significant improvement in exercise groups compared with controls for breast cancer concerns at baseline to 12 weeks and six months. There was a significant decrease in anxiety in the exercise group compared to controls at 12 weeks only (standardized mean difference [SMD] = -0.26; 95% confidence interval [CI] [-0.44, -0.07]) but not in breast cancer-only analysis. There was a high risk of bias in most of these studies, and when these were removed, the results were not significant. Significant differences were noted in body image at follow-up (12 weeks to six months and beyond) using the Rosenberg Self-Esteem Scale. Significant change scores were noted for cancers other than breast for improving depression scores (SMD = -0.46; 95% CI [-0.72, -0.19]). Significant improvements were noted in emotional well being (12 weeks) and fatigue (12 weeks and 6 months) (SMD = -0.42; 95% CI [-0.83, -0.02]). No effects after six months were seen for fatigue, and effects were not significant when studies involving patients during treatment were excluded. Improvement in pain using follow-up scores (12 weeks) was seen (SMD = -0.29; 95% CI [-0.55, -0.04]), but this was from a single trial. Positive effects were noted in sexuality scores at six months and sleep disturbance at 12 weeks (sleep SMD = -0.46; 95% CI [-0.72, -0.20]). Significant improvements were noted in change scores for social functioning (12 weeks and six months). No significant changes were noted in cognitive function, general health perspective, role function, and spirituality in exercise trials.

Conclusions

Exercise interventions showed beneficial effects on HRQoL and some HRQoL domains, including breast cancer concerns, body image, emotional well being, sexuality, sleep disturbances, social functioning, anxiety, fatigue, and pain at various follow-up time points.

Limitations

  • Studies included used exercise programs of various types, intensity levels, and lengths.
  • Significant effects found tended to be in subgroups of patients or at only one time point, limiting the confidence in observed effects.
  • Measures of HRQoL varied, creating heterogeneity among the studies in how HRQoL was quantified.
  • There was a high risk of bias in the trials reviewed. In many cases, no significant effects were seen when analyzing changes in symptoms from baseline to follow-up time points, and significant findings were seen in comparing only follow-up scores between various comparison groups. Results should be used with caution for these reasons.

Nursing Implications

Findings supported the general benefit of exercise for patients with cancer; however, there is further need for research to verify the positive effects of exercise on symptoms of cancer in various patient groups and at various phases of cancer care. These future research studies should determine how to produce larger effect sizes over time and delineate predictors of that effect, such as type of exercise, intensity of the program, timing, and type of cancer and treatment in order to maximize the effect on QoL. It will be important to note that certain questionnaires can affect the outcomes, and consistency would improve this body of research.

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Papadopoulos, D., Papadoudis, A., Kiagia, M., & Syrigos, K. (2018). Nonpharmacologic interventions for improving sleep disturbances in patients with lung cancer: A systematic review and meta-analysis. Journal of Pain and Symptom Management, 55, 1364–1381.

Purpose

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

Search Strategy

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

Literature Evaluated

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.

Sample Characteristics

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 and Clinical Applications

PHASE OF CARE: Multiple phases of care

Results

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.

Conclusions

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.

Limitations

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

Nursing Implications

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.

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Research Evidence Summaries

Armbruster, S.D., Song, J., Gatus, L., Lu, K.H., & Basen-Engquist, K.M. (2018). Endometrial cancer survivors' sleep patterns before and after a physical activity intervention: A retrospective cohort analysis. Gynecologic Oncology, 149, 133–139.

Study Purpose

To determine baseline sleep characteristics of endometrial cancer survivors, the impact of demographic and treatment characteristics on sleep quality, the association of sleep quality with quality of life and stress levels, and the impact of physical activities on sleep.

Intervention Characteristics/Basic Study Process

Individualized exercise prescriptions based on baseline function. Adherence to the American College of Sports Medicine Guidelines requiring 30 minutes of moderate exercise five or more days per week or at least 20 minutes of rigorous exercise three or more days per week with telephone-based counseling sessions, printed materials, and pedometers. Decreasing frequency of counseling telephone calls from weekly to twice monthly to monthly over six months.

Sample Characteristics

  • N = 95   
  • AGE: 57.1 years (range = 25-76)
  • FEMALES: 100%
  • CURRENT TREATMENT: Radiation, other
  • KEY DISEASE CHARACTERISTICS: 76% stage I

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Houston, TX

Phase of Care and Clinical Applications

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

Study Design

Secondary analysis of Steps to Health, a single-arm cohort study.

Measurement Instruments/Methods

Sleep quality measured with the Pittsburgh Sleep Quality Index (PSQI). Physical activity measured with the Community Health Activities Model Program for Seniors (CHAMPS). Quality of life (QOL) measured with the SF-36.

Results

At baseline, 61% of the sample had poor sleep quality (PSQI > 5). Obese survivors were more likely to have sleep disturbances than were their normal-weight counterparts (p = 0.029). At baseline, poor sleepers had higher stress levels than good sleepers (p = 0.002). Poor sleep quality was associated with lower health-related QOL: vitality (p = 0.001), bodily pain (p = 0.004), general health (p = 0.002), social functioning (p = 0.005), role limitations caused by emotional problems (p = 0.005), mental health (p = 0.002), and the mental component score (p = 0.003). Sleep quality improved in cancer survivors who increased their weekly total physical activity or moderate-vigorous intensity physical activities (MPVA) throughout the intervention (p = 0.004 and 0.05, respectively). Adjusting for covariates (e.g., age, time since diagnosis, obesity status, disease stage, treatment), improvement in sleep quality was associated with increased hours of total activity (p = 0.026).

Conclusions

Poor sleep quality was common in endometrial cancer survivors and an increase in physical activity was associated with improved sleep quality.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)

Nursing Implications

Sleep problems are common in women following treatment for endometrial cancer and are associated with stress and poor QOL. Increasing physical activity may improve sleep quality for these women.

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Brown, J.C., Damjanov, N., Courneya, K.S., Troxel, A.B., Zemel, B.S., Rickels, M.R., . . . Schmitz, K.H. (2018). A randomized dose-response trial of aerobic exercise and health-related quality of life in colon cancer survivors. Psycho-Oncology, 27, 1221–1228.

Study Purpose

To determine the dose-response effect of aerobic exercise on health-related quality of life outcomes among colon cancer survivors after treatment completion, including functional status, sleep, fatigue, fear of recurrence, and bowel function.

Intervention Characteristics/Basic Study Process

The intervention was a prescription for home-based aerobic exercise over six months–either low-dose aerobic exercise (150 minutes per week) or high-dose aerobic exercise (300 minutes per week). Each participant received a treadmill and a heart rate monitor. An exercise physiologist provided ongoing in-person, telephone, and email support, individualized to each participant, and monitored adherence to the exercise protocol.   Exercise intensity was prescribed at 50%-70% of age-predicted maximum heart rate and gradually increased for each participant to meet their goal.

Sample Characteristics

  • N = 39  
  • AGE: Younger than 60, n = 25 (64%); older than 60, n = 14 (36%)
  • MALES: 38%  
  • FEMALES: 62%

Setting

  • SITE: Single site   
  • SETTING TYPE: Home    
  • LOCATION: Philadelphia, PA

Phase of Care and Clinical Applications

PHASE OF CARE: Transition phase after active treatment

Study Design

Randomized controlled trial with three groups: usual care (usual recommendations for activity), low-dose aerobic exercise (150 minutes per week), and high-dose aerobic exercise (300 minutes per week).

Measurement Instruments/Methods

Medical Outcomes Survey Short Form (SF-36), Functional Assessment of Cancer Therapy–Colorectal (FACT-C), Pittsburgh Sleep Quality Index (PSQI), Fear of Cancer Recurrence Inventory (FCRI), Fatigue Symptom Inventory (FSI), North Central Cancer Treatment Group questionnaire (bowel function)

Results

Physical health score in SF-36 improved by 1.2 (d = 0.08) in the low-dose group and 13.1 (d = 0.58) in the high-dose group. FACT-C scores increased by 7.6 (d = 0.49) in the low-dose group and 6.8 (d = 0.58) in the high-dose group. PSQI scores decreased by 0.3 in the low-dose group (d = -0.11) and by 1.1 (d = -0.3) in the high-dose group. PSQI subscales of sleep quality and sleep latency showed improvement. FSI scores increased by 0.8 (d = 0.08) in the low-dose group and decreased by 6 (d = -0.75) in the high-dose group. There were no changes observed in mental health scores of SF-36, FCRI scores, or bowel function scores.

Conclusions

The six-month home-based aerobic exercise intervention for survivors of colon cancer improved health-related outcomes, including physical function, quality of life, sleep quality, and fatigue. Improvements were dose-related, such that a higher dose of aerobic exercise resulted in greater improvement in outcomes.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Findings not generalizable
  • Other limitations/explanation: The home-based intervention included giving each participant a treadmill and individualized support from an exercise physiologist for six months, which may not be feasible for the larger population.

Nursing Implications

Moderate intensity aerobic exercise in excess of the recommended 150 minutes per week showed clinically meaningful improvements in health-related outcomes, including physical function, quality of life, sleep quality, and fatigue in survivors of colon cancer who have completed treatment.

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Chen, H.M., Tsai, C.M., Wu, Y.C., Lin, K.C., & Lin, C.C. (2016). Effect of walking on circadian rhythms and sleep quality of patients with lung cancer: A randomised controlled trial. British Journal of Cancer, 115, 1304–1312.

Study Purpose

To assess the effects of a 12-week walking program on improving subjective and objective sleep quality and rest-activity rhythms in patients with lung cancer

Intervention Characteristics/Basic Study Process

Home-based walking exercise at moderate intensity and weekly exercise counseling were provided. Participants were given detailed instruction according to a manual for the exercise program, including determination of intensity, pulse monitoring, rating perceived exertion, prevention of injury, and conditions requiring termination of the exercise program. Weekly exercise-related phone counseling was provided to reinforce teaching and encourage continued participation. The usual care control group was given typical services and asked to maintain normal activity and not perform additional exercise. Exercise counseling was offered to the usual care group at the end of the study. An actigraph was worn by patients to collect data continuously for 72 hours.

Sample Characteristics

  • N = 111, 89 assessed at six months
  • MEAN AGE = 63.6 years
  • AGE RANGE = 37–83 years
  • MALES: 44.1%, FEMALES: 55.9%
  • CURRENT TREATMENT: Combination radiation and chemotherapy, other
  • KEY DISEASE CHARACTERISTICS: All had surgery for lung cancer, and most were receiving radiation and chemotherapy. Most had stage I disease.
  • OTHER KEY SAMPLE CHARACTERISTICS: Eighty-two percent were married. Patients were an average of 454 days since diagnosis.

Setting

  • SITE: Single-site   
  • SETTING TYPE: Home    
  • LOCATION: Taiwan

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Pittsburgh Sleep Quality Index (PSQI)
  • Actigraphy for evaluation of rest activity parameters, sleep parameters, and physical activity

Results

Overall participants completed 58.2% of all planned exercise sessions. The usual care group showed a higher mean amount of moderate physical activity at all time points when measured (37–46 minutes per day compared to 38–10 minutes per day at three and six months). No significant difference over time was reported between groups. The walking exercise group had improved PSQI scores over time compared to the usual care group (p = 0.001). No differences between groups in objective measures of sleep quality existed, except that total sleep time at six months was higher in the exercise group (p = 0.023).

Conclusions

Sleep quality measures showed improvement in the study group compared to the controls; however, given that the average amount of moderate intensity exercise was higher in the control group, the impact of walking exercise versus counseling is unclear.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Key sample group differences that could influence results
  • Measurement/methods not well described
  • Subject withdrawals ≥ 10%
  • It was stated that baseline minutes of moderate activity differed significantly between study groups; however, data were not provided, and the direction of difference is unknown.
 

 

Nursing Implications

The effect of exercise on sleep quality in patients with insomnia remains unclear from this study. Although measures showed improvement in the walking exercise group compared to the controls, the amount of moderate intensity exercise was actually higher in the control group. This does not point to the impact of exercise on differences seen in this study.

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Cheville, A.L., Kollasch, J., Vandenberg, J., Shen, T., Grothey, A., Gamble, G., & Basford, J.R. (2013). A home-based exercise program to improve function, fatigue, and sleep quality in patients with stage IV lung and colorectal cancer: A randomized controlled trial. Journal of Pain and Symptom Management, 45, 811–821.

Study Purpose

To report the effects of a strength training and walking program in patients with stage IV lung and colorectal cancer.

Intervention Characteristics/Basic Study Process

Patients were given usual care or 1.5 hours of training by a physical therapist on rapid, easy, strength training exercises (REST) and pedometer-based walking using an instruction manual, resistance bands, an exertion rating scale, and a study log. They were then followed bimonthly by telephone for eight weeks.

Sample Characteristics

  • The study reported on a final sample of 56 patients.
  • Mean patient age was 63.8 years in the intervention group and 65.5 years in the control group.
  • The intervention group was 48.5% male and 51.5% female. The control group was 57.6% male and 42.4% female.
  • Patients had stage IV lung or colorectal cancer.

Setting

  • Single site 
  • Outpatient setting
  • Mayo Clinic

Phase of Care and Clinical Applications

Patients were undergoing the end of life phase of care.

Study Design

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

Measurement Instruments/Methods

  • Activity Measure for Post-Acute Care Computerized Adaptive Testing (AM-PAC CAT)
  • AM-PAC Mobility
  • Functional Assessment of Cancer Therapy-General (FACT-G)
  • FACT-Fatigue (FACT-F) subscale
  • Numerical rating scale for pain and sleep quality
  • Pedometer step-count logs
  • REST logs
  • Vital sign collection

Results

Mobility, fatigue, and sleep measures were statistically significant between the intervention and control groups from baseline to week 8 (p = 0.002, p = 0.03, and p = 0.002, respectively), in favor of exercise. Other measures did not show significance. The number of REST sessions and weeks logged with step counts were associated with changes in the mobility score. Survival and withdrawals did not differ significantly between the groups.

Conclusions

A home-based intervention using walking and strength exercises may improve mobility, fatigue, and sleep quality in patients with stage IV colorectal or lung cancer.

Limitations

  • The study had a small sample size, with less than 100 participants.
  • The study had risks of bias due to no blinding and no appropriate attentional control condition.

Nursing Implications

The teaching of walking exercises and strength routines may improve functioning in this patient population in terms of mobility, sleep quality, and fatigue. The one-time education session may be appealing to nurses looking for a timely intervention to help improve these symptoms.

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Coleman, E. A., Coon, S., Hall-Barrow, J., Richards, K., Gaylor, D., & Stewart, B. (2003). Feasibility of exercise during treatment for multiple myeloma. Cancer Nursing, 26, 410–419.

Intervention Characteristics/Basic Study Process

A home-based exercise program was used that included aerobic and resistance training. The exercise group received an individualized exercise prescription, with strength levels and aerobic capacity at first testing. The control group received usual care. Outcomes were exercise, fatigue, mood, and sleep.

Sample Characteristics

  • The sample was comprised of 24 Caucasian patients (10 women, 14 men).
  • Mean age was 55 years.
  • Patients were on high-dose chemotherapy and were receiving peripheral blood stem cell transplant for multiple myeloma (with bone involvement).

Setting

  • Outpatient
  • Cancer research center
  • Midwestern United States

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

The study was a pilot feasibility, randomized, controlled trial.

Measurement Instruments/Methods

  • A wrist actigraph was used to measure latency, minutes of sleep at night, percent of time asleep at night, number of nighttime awakenings, frequency of daytime naps, minutes of sleep during the daytime, and total minutes of sleep during each 24-hour period.
  • The Epworth Sleepiness Scale (ESS) also was used.

Results

The feasibility of an individualized exercise program for patients receiving aggressive treatment for multiple myeloma was determined.

Limitations

  • The study had a small sample size.
  • The study had a 42% attrition rate; equal attrition was noted in both groups.
  • Valid and reliable sleep latency is difficult to determine from actigraphy.
  • The test is time consuming and a burden to patients.
  • An exercise testing facility is needed.
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Coleman, E. A., Goodwin, J. A., Kennedy, R., Coon, S. K., Richards, K., Enderlin, C., . . . Anaissie, E. J. (2012). Effects of exercise on fatigue, sleep, and performance: a randomized trial. Oncology Nursing Forum, 39, 468–477.

Study Purpose

To compare usual care with a home-based individualized exercise program (HBIEP) in patients receiving intensive treatment for multiple myeloma (MM) and epoetin alfa therapy.

Intervention Characteristics/Basic Study Process

This was a randomized trial with repeated measures of two groups (one experimental and one control) and an approximate 15-week experimental period for the HBIEP. The control group received a recommendation to walk 20 minutes three times per week. In the HBIEP, patients were given color-coded stretch bands and materials to illustrate exercises to be used, and they were to perform aerobic walking to reach 65% to 80% of the maximal heart rate. Patients mailed in weekly activity summaries. Assessments were performed at baseline, 10 to 12 weeks later prior to the second chemotherapy cycle, and three to four weeks later when finishing stem cell collection.

Sample Characteristics

  • The study was comprised of 187 patients (92 in usual care and 95 in the intervention).
  • Age ranged from 35 to 76 years in the usual care group and 25 to 76 years in the intervention group.
  • In the usual care group, 60% of patients were male and 40% were female.  In the intervention group, 57% of patients were male and 43% were female.
  • Patients were newly diagnosed with MM and were eligible for treatment with an aggressive protocol that included stem cell transplant. 
  • The majority of patients were well educated and had great motivation to exercise. The intent of the intervention was to determine whether specific exercises were more effective in improving sleep and decreasing fatigue.

Setting

  • Single site
  • Multiple settings
  • Southern United States international referral center

Phase of Care and Clinical Applications

  • Patients were undergoing the active antitumor treatment phase of care.
  • The study has clinical applicability for elder care. 

Study Design

This was a randomized, controlled trial with repeated measures of two groups and a 15-week experimental period.

Measurement Instruments/Methods

  • Profile of Mood States (POMS) Fatigue Scale
  • Functional Assessment of Cancer Therapy-Fatigue (FACT-F)
  • Actigraph recordings
  • Six-minute walk test
  • Hemoglobin levels at baseline and before and after stem cell collection
  • Descriptive statistics used to compare demographics
  • Treatment effects and repeated measures ANOVA used to determine effects of HBIEP

Results

No statistically significant differences existed among the experimental and control groups for fatigue, sleep, or performance (aerobic capacity). Statistically significant differences (p < 0.05) were found in each of the study outcomes for all patients as treatment progressed, and patients experienced more fatigue and poorer nighttime sleep and performance.

Conclusions

The effect of exercise seemed to be minimal on decreasing fatigue, improving sleep, and improving performance. Exercise is safe and has physiologic benefits for patients undergoing MM treatment and, when combined with epoetin alfa, helped to alleviate anemia.

Limitations

  • The study had a risk of bias (sample characteristics) because it consisted of mostly well-educated patients.
  • A key sample group difference that could influence the results included the inclusion of mostly well-educated patients.
  • Patients self-reported compliance with HBIEP. This was a home-based program, so no observation was performed. 
  • Patients in the control group were not discouraged from exercising.
  • No patient could perform the strength tests.
  • Anemia was present at baseline in the majority of patients, and all participants would become anemic with treatment; therefore, all patients received treatment for anemia, which potentially limited the results.

Nursing Implications

Although the results might indicate no derived benefit, patients became more fatigued, slept less, and experienced a decline in performance with more treatment. The HBIEP group required fewer red blood cell transfusions to maintain a similar hemoglobin level, less platelet transfusions, and fewer days to collect stem cells. When combined with epoetin alfa therapy, exercise had an effect in decreasing cancer-related anemia and improving cell count recovery after high-dose chemotherapy. These are benefits to patients and the healthcare economy. Cancer rehabilitation exercises may result in improved performance. Having fatigue prior to treatment might predict having fatigue after treatment. Energy conservation measures should be considered with endurance and resistance exercises. Rehabiltation therapy might be needed for deconditioned patients. Exercise should be tailored individually based on the patient's disease stage, presence of bone lesions, and values. The HBIEP may have helped to alleviate anemia, but there is no evidence that HBIEP combining muscle strengthening and aerobic walking exercises decreases fatigue.

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Courneya, K.S., Segal, R.J., Mackey, J.R., Gelmon, K., Friedenreich, C.M., Yasui, Y., . . . McKenzie, D.C. (2014). Effects of exercise dose and type on sleep quality in breast cancer patients receiving chemotherapy: A multicenter randomized trial. Breast Cancer Research and Treatment, 144, 361–369.

Study Purpose

To compare the effects and doses of a three-arm exercise trial to improve sleep quality in patients with breast cancer receiving active chemotherapy

Intervention Characteristics/Basic Study Process

The three-group design of the CARE trial compared the standard dose of 25–30 minutes of aerobic exercise (STAN) to higher doses of activity that included 50–60 minutes of aerobic exercise (HIGH) and 50–60 minutes of combined-dose of aerobic and resistance exercise (aerobic and strength training three times per week) (COMB). COMB strength training was part of the 50–60 minute session and included two sets of 10–12 repetitions of nine different strength exercises at 60%–75% of the estimated one-repetition max (RM). All groups received three weekly treatments with outcomes measures to determine primary and secondary outcomes. Interventions continued for the duration of chemotherapy. Data were collected at baseline, midpoint 1, midpoint 2, and postintervention.

Sample Characteristics

  • N = 296
  • MEAN AGE = > 18 years M = 50 (SD = 8.7 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Patients with breast cancer receiving active chemotherapy
  • OTHER KEY SAMPLE CHARACTERISTICS: English or French speaking; not pregnant; stages I–IIIc

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Multiple settings    
  • LOCATION: Canada

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Blinded, randomized, controlled trial

Measurement Instruments/Methods

  • Primary outcomes were measured using the Pittsburgh Sleep Quality Index (PSQI).
  • Secondary outcomes for moderators for plausibility included clinical utility, support for previous research used, age, aerobic exercise guidelines, strength exercise guidelines, comorbidities, body mass index, aerobic fitness (treadmill and gas exchange), and medical moderators from records (stage, surgery, and chemotherapy).

Results

296 patients completed the study with complete data. Baseline global sleep scores were M = 6.2 (SD = 4.1) with 52% of participants reporting poor sleep at baseline (PSQI > 5). The main effects of the study showed that the HIGH group had statistically better outcomes compared to the STAN group for primary sleep global scores (d = 0.22; p = 0.039), sleep quality (d = 0.26; p = 0.028), and sleep latency (d = 0.18; p = 0.049). The COMB group barely scored significantly higher than the STAN group for global sleep quality, sleep duration, and sleep efficiency (d = 0.24; p = 0.04)  and percent of poor sleepers (d = 0.20; p = 0.045). The HIGH group was statistically better than COMB for sleep latency only (d = 0.20; p = 0.04) . Significant moderators included surgery, baseline aerobic fitness, baseline aerobic exercise guidelines, baseline strength guidelines, and number of comorbid conditions. The effect size for the HIGH group compared to the STAN group was larger for global sleep quality for lumpectomy patients with no comorbid conditions, those meeting aerobic exercise guidelines, and those who were fitter at baseline. Scores in the COMB group were higher than those of the STAN group for lumpectomy patients meeting strength exercise guidelines. The overall effect for each arm was small.

Conclusions

Higher doses of exercise and the combination of exercise and strength training were associated with better overall sleep quality compared to the standard dose of 50–60 minutes of aerobic exercise. Different sleep components appeared to be most affected by the type of exercise intervention, and no single intervention impacted all the sleep components measured.

Limitations

  • Measurement validity/reliability questionable
  • Findings not generalizable
  • Intervention expensive, impractical, or training needs
  • Other limitations/explanation: There were no noted statistics to compare the three intervention groups as reported in the manuscript, so it is unclear whether group differences were present. The findings of this study only are generalizable to breast cancer and cannot be generalized to other active patients with cancer. The intervention assumes that patients have access to exercise support and gyms with the COMB part of the intervention. This might not be realistic for some areas with rural populations. The PSQI was validated using all 19 items, but this study eliminated nine (sleep disturbance) questions without a validation of the questionnaire, thus reducing the overall validity and reliability of the findings that were based on the global sleep quality index.

Nursing Implications

Nurses often suggest maintaining activity during treatment, but there is little information about the effectiveness of this recommendation on sleep-wake disturbances. This study provided a large sample of patients with breast cancer that narrowed down the doses needed to affect sleep. The overall results of this study suggest that exercise can improve sleep during chemotherapy treatment. However, the limitations of this study need to be taken into consideration before recommending the actual interventions used.

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Courneya, K.S., Sellar, C.M., Trinh, L., Forbes, C.C., Stevinson, C., McNeely, M.L., . . . Reiman, T. (2012). A randomized trial of aerobic exercise and sleep quality in lymphoma patients receiving chemotherapy or no treatments. Cancer Epidemiology Biomarkers & Prevention, 21, 887–894.

Study Purpose

To test the hypothesis that aerobic exercise would be better than usual care for improving sleep quality, and to examine potential moderators of intervention effects

Intervention Characteristics/Basic Study Process

Patients were stratified by lymphoma type and whether the patient was receiving chemotherapy and then randomized to receive the exercise intervention or usual care. The intervention consisted of supervised aerobic sessions three days per week for 12 weeks. Prescriptions for unsupervised exercise were provided for patients who were unable or unwilling to attend supervised sessions, and these sessions were not counted in adherence evaluation. Usual care patients were asked to not change baseline exercise habits and were offered supervised exercise after final study assessments.

Sample Characteristics

  • N = 117
  • AGE: 32.5% were younger than 50 years, and the rest were older than 50 years. No other age information is provided.
  • MALES: 59%, FEMALES: 41%
  • KEY DISEASE CHARACTERISTICS: All had non-Hodgkin lymphoma, 54.7% were off treatment, and 45.3% were in active treatment.  
  • OTHER KEY SAMPLE CHARACTERISTICS: At baseline, 71.8% were not meeting recommended activity guidelines. At baseline, overall, 47% were poor sleepers. The prevalence of poor sleepers was higher in the intervention group (57.9% compared to 36.7%, p = .021).

Setting

  • SITE: Not stated/unknown  
  • SETTING TYPE: Outpatient  
  • LOCATION: Canada

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care

Study Design

  • RCT

Measurement Instruments/Methods

  • Pittsburgh Sleep Quality Index

Results

Aerobic exercise resulted in a small (d = -0.19) but not significant improvement in global sleep quality. In the intervention group, the exercise program improved global sleep quality in patients receiving chemotherapy (p = .013), but not for those who were off therapy. Exercise improved global sleep quality in those who were poor sleepers at baseline (p = .007), but not in those who were good sleepers at baseline.  Analysis further showed that positive effects of exercise were seen in patients with shorter time since diagnosis, patients who were obese, and patients who had less aggressive disease.

Conclusions

Aerobic exercise did not significantly improve sleep quality in this study of patients with lymphoma. Exercise appeared to have some benefits for sleep quality in individuals who were in active treatment.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Key sample group differences that could influence results
  • Other limitations/explanation: Findings showed that those with poor sleep quality had a greater effect with aerobic exercise, and, at baseline, more poor sleepers were in the intervention group. This suggests that actual effects may be even lower for exercise than shown here. No statement is provided of how many patients did not participate in the supervised exercise sessions and how this was handled in overall analysis of group differences.

 

Nursing Implications

Findings show that overall, participation in aerobic exercise does not improve overall sleep quality in patients with lymphoma. Some benefit may exist for patients during chemotherapy treatment and for individuals who have baseline poor sleep quality. For these types of patients, nurses should consider suggesting aerobic exercise or providing exercise prescriptions.

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Kwiatkowski, F., Mouret-Reynier, M.A., Duclos, M., Leger-Enreille, A., Bridon, F., Hahn, T., . . . Bignon, Y.J. (2013). Long term improved quality of life by a 2-week group physical and educational intervention shortly after breast cancer chemotherapy completion. Results of the 'Programme of Accompanying women after breast Cancer treatment completion in Thermal resorts' (PACThe) randomised clinical trial of 251 patients. European Journal of Cancer, 49(7), 1530–1538.

Study Purpose

Determine the effectiveness of an intensive intervention (i.e., two weeks at a SPA centre involving exercise, physiotherapy, and dietary education) on overall quality of life, weight, nutrition, and physical activity in women who recently had completed treatment for non-metastatic breast cancer

Intervention Characteristics/Basic Study Process

The intervention included a two-week stay at a SPA centre with a daily routine of physical training (i.e., two hours daily under the supervision of a physiotherapist, which included walking, strength training, and aquaexercise), dietary education with cooking lessons and provision of healthy meals, and aesthetic care, massage, etc. Dietary consultations every six months for three years also were incorporated into standard follow-up care.

Sample Characteristics

  • N = 222
  • MEAN AGE: Intervention group: 51.8 years (SD = 8.7 years), control group: 52.3 years (SD = 10.1 years)
  • MALES: 0%, FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: The stage of cancer is not reported; it's described only as invasive and non-metastatic. A description of disease characteristics is not reported. Subjects had completed treatment (chemo and/or radiation) for breast cancer less than nine months prior to study enrollment. The majority of patients received chemotherapy and radiation therapy, and more than two-thirds of the sample were on hormonal therapy; a minority (less than 15%) were on trastuzumab as well.
  • OTHER KEY SAMPLE CHARACTERISTICS: No significant differences were seen between the treatment and control group, except for a statistically significant difference in smoking history, in that a greater percentage of the treatment group reported a history of smoking.

Setting

  • SITE: Not stated/unknown 
  • SETTING TYPE: Other 
  • LOCATION: This is a French study. The intervention occurred at three different SPA centres, also mentioned as “thermal centres.” From where the sample was recruited is not reported.

Phase of Care and Clinical Applications

PHASE OF CARE: Transition phase after active treatment

Study Design

Prospective, randomized, repeated measures (baseline, 6, 12, 18, and 24 months after intervention) two-group clinical trial

Measurement Instruments/Methods

  • Short Form 36 Health Survey (SF-36) as quality-of-life measure
  • Hospital Anxiety and Depression Scale (HADS)
  • Adapted Leeds Sleep Evaluation Questionnaire
  • Ricci & Gagnon questionnaire for physical activity
  • Questionnaire for sitting time and impedancemetry for body composition

Results

Statistically significant differences were seen between groups on the SF-36 measure at six months, but these differences did not persist in any dimension at year one except for a difference in vitality at one year between groups. Although data were collected on weight/body mass index, diet, and sleep, results for these variables are not reported (except to note no significant differences in sleep between the groups). The plots/trends in quality of life over time (at 6, 12, 18, and 24 months) look very similar for both groups, except for a significant upward trend at six months for the intervention group. The correlation was stronger between HADS depression and SF-36 quality of life. In the SPA group, an overall decrease was seen in anxiety compared to baseline scores (p = 0.0005). No significant difference was seen in the anxiety scores between the SPA and control groups at six months. Depression decreased in both groups but to a greater degree in the SPA group. A significant difference was seen between the SPA group and control group in terms of depression scores. What the “control” or comparison group was or what care was given to them is not clear.

Conclusions

As reported, patients with non-metastatic breast cancer did not appear to derive significant benefit (improved quality of life as measured by the SF-36) from a two-week SPA intervention in terms of improving quality of life and reducing anxiety and depression.

Limitations

This unrealistic intervention (two-week SPA stay) does not seem sustainable. Furthermore, if this “intensive” intervention did not demonstrate significant impact on quality of life or anxiety, except for depression, then the “cost” of such an intensive intervention is not worth the benefit. When exactly the intervention occurred is not reported relative to timing of completion of breast cancer treatment except to say “within nine months,” but this is an important variable/covariate because time since treatment completion (and intervention) might impact study results. Importantly, unclear is how subjects were screened or that only a “distressed” group was enrolled. The report that global SF-36 scores at study inclusion were 56 and 54 respectively (treatment and control groups) indicates that this is not a very “stressed” group, as evidenced by SF-36. The higher the scores on the SF-36, the better the quality of life. These scores at study inclusion are right at the midpoint range of 0%–100%; thus, a possible floor effect is at play. Overall, this is not a very well developed or reported study.

Nursing Implications

No real meaningful nursing implications are drawn from this study. The intervention seems unrealistic and unsustainable and did not impact outcome measures as predicted, except for depression.

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Mock, V., Dow, K. H., Meares, C. J., Grimm, P. M., Dienemann, J. A., Haisfield-Wolfe, M. E., . . . Gage, I. (1997). Effects of exercise on fatigue, physical functioning, and emotional distress during radiation therapy for breast cancer. Oncology Nursing Forum, 24, 991–1000.

Intervention Characteristics/Basic Study Process

A self-paced, progressive, home-based exercise program (walking exercise versus usual care) was used. Individualized walking was based on age, level of fitness, and history of exercise. The program was a brisk, incremental, 20- to 30-minute walk, followed by a 5-minute slow walking cool-down, four to five times per week for six weeks. Outcomes were exercise, fatigue, physical functioning, emotional distress, and sleep.

Sample Characteristics

  • The sample was comprised of 46 females.
  • Mean age was 49 years.
  • Of the patients, 87% were Caucasian and 72% had stage I breast cancer and were undergoing radiotherapy.

Setting

  • Two university teaching hospitals
  • Instructions were given at the institution, but the intervention was performed at home.
  • Southeastern United States

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

The study used a two-group, controlled, pre-/posttest experimental design.

Measurement Instruments/Methods

  • Symptom Assessment Scale (SAS)
  • Piper Fatigue Scale (PFS)
  • 12-minute walk test
  • Sociodemographic information

Results

Women who exercised regularly reported less difficulty sleeping than the control group.

Limitations

  • Only the first patient received random assignment. Subsequent patients were alternately assigned to the usual care or exercise groups.
  • A diffusion effect was possible for exercisers in the usual care group.
  • The study had a small sample size.
  • The study lacked control over the intervention in the home.
  • Patients had to adhere to a five-day-a-week regimen.
  • Exercise physiologist consultation is needed.
  • RNs must be trained in delivering the intervention.
  • The study should be supervised by a principal investigator.

Nursing Implications

Caution:  maintain safety while exercising.

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Naraphong, W., Lane, A., Schafer, J., Whitmer, K., & Wilson, B.R. (2015). Exercise intervention for fatigue‐related symptoms in Thai women with breast cancer: A pilot study. Nursing and Health Sciences, 17, 33–41.

Study Purpose

To test the feasibility and provide a preliminary evaluation of the effects of an exercise program for fatigue, sleep disturbance, mood, and symptoms in patients with cancer

Intervention Characteristics/Basic Study Process

Participants randomly were assigned to the treatment or control group. Patients in the control group received usual care, an educational booklet and DVD, and weekly telephone calls. Patients in the experimental group received initial one-on-one training sessions and were given exercise program kits containing written instructions, a pedometer, and an exercise log. Patients were to choose activities that provided low to moderate intensity exercise and perform these daily for at least 20 minutes. Participants also were asked to walk three to five days per week. Weekly phone calls to the experimental group were made to monitor participation and make adjustments to the walking prescription as needed. The program was planned for 12 weeks.

Sample Characteristics

  • N = 23
  • MEAN AGE = 46.78 years (range = 31–59 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All patients had breast cancer (mostly stage II). Patients were recruited during chemotherapy given postoperatively.

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Piper Fatigue Scale (PFS)
  • General Sleep Disturbance Scale (GSDS)
  • Profile of Mood States–Short Form (POMS-SF)
  • Memorial Symptom Assessment Scale (MSAS)

Results

Patients in the experimental group demonstrated a nonsignificant improvement in fatigue (d = -0.48). There were no significant group by time effects for other measures. Data were not collected after week 10 because of loss of subject follow-up.

Conclusions

The findings of this study support the known effect of exercise on cancer-related fatigue; however, the small sample in this study limits the strength of these findings.

Limitations

  • Small sample (< 30)
  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Subject withdrawals ≥ 10%
  • Other limitations/explanation: Patients in the control group reported higher fatigue levels at baseline.

Nursing Implications

This study provides minimal additional support for the benefits of exercise among women with breast cancer during active treatment. Exercise has been shown to be effective in reducing multiple symptoms, and nurses should encourage patients to be active.

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Payne, J. K., Held, J., Thorpe, J., & Shaw, H. (2008). Effect of exercise on biomarkers, fatigue, sleep disturbances, and depressive symptoms in older women with breast cancer receiving hormonal therapy. Oncology Nursing Forum, 35, 635–642.

Study Purpose

To determine if a home-based walking program is more effective than usual care in reducing fatigue, sleep disturbances, and symptoms of depression in older women receiving hormone treatment for breast cancer.

Intervention Characteristics/Basic Study Process

Patients were recruited from breast cancer clinics and randomized to usual care or a prescribed exercise program that focused on walking. Researchers followed patients' progress over a 14-week period. Patients completed study instruments at baseline, two weeks later via mail, 12 weeks after baseline at a clinic visit, and 14 weeks after baseline via mail. Cortisol, serotonin, interleukin-6 (IL-6), and bilirubin were collected at the initial clinic visit and again at three months. At visit 1 and at 12 weeks, patients were asked to wear a sleep-watch actigraph for 72 continuous hours. The walking exercise intervention was a moderate walking activity for 20 minutes, four times a week. Patients were to log the duration and frequency of walking activity.

Sample Characteristics

  • The sample was comprised of 18 women.
  • Mean age was 65 years (range 56–78).
  • All patients had breast cancer and were being treated, by means of hormone therapy, with tamoxifen, anastrozole, or letrozole.
  • Of the patients, 65% were married, 55% were retired, 90% were Caucasian, and 40% had education at the college level or higher.
  • Inclusion criteria were postmenopausal status and fatigue.

Setting

  • Single site
  • Outpatient
  • Comprehensive cancer center in the southeastern United States

Study Design

The study was a longitudinal, repeated-measures, randomized, clinical trial.

Measurement Instruments/Methods

  • Revised Piper Fatigue Scale (PFS-R)
  • Pittsburgh Sleep Quality Index (PSQI)
  • Center for Epidemiologic Studies Depression Scale (CESD)
  • Sleep measurements collected by means of actigraphy

Results

Levels of fatigue over time and between groups were not significantly different. PSQI scores decreased significantly over time in the exercise group (p = 0.007) and did not change in the usual care control. Actigraphy analysis after 12 weeks showed a shorter wake time (p = 0.02), sleep time (p = 0.05), and less movement during sleep (p = 0.002) in the exercise group. There was no difference between groups in regard to sleep efficiency, which is the ratio of total sleep time to time in bed. There were no differences in cortisol levels over time or between groups. ANOVA showed a significant difference between groups and across time in serotonin levels, with an intervention effect of exercise (p = 0.009). There were no differences between groups or over time in regard to symptoms of depression.

Conclusions

A home-based walking intervention appears to be acceptable to older women receiving hormone therapy for breast cancer and an intervention that is feasible for use in that population. Decline in PSQI scores in the exercise group suggest that this type of intervention may help improve sleep quality in this population. Effects of the exercise intervention on biomarkers are unclear.

Limitations

  • The study had a small sample size, with less than 30 patients.
  • There was no intention-to-treat analysis.
  • The study had a risk of bias due to no appropriate attentional control group.
  • Although significance values were reported, the authors provided no other statistical results regarding significant findings. Such results would enable evaluation of the strength of the relationships.
  • The authors did not report actual adherence to the exercise program, so the use of exercise as prescribed cannot be determined. It is also unknown whether members of the control group exercised on their own.
  • The use of patient self-reporting—in this case, of exercise—is a limitation in itself. Furthermore, the authors did not provide or discuss the patient self-reports or their analysis.

Nursing Implications

An exercise program involving walking may be helpful to patients receiving hormone treatment for breast cancer, but the actual effects of such a program on fatigue, sleep, and symptoms of depression are unclear.

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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.

Study Purpose

To assess the feasibility, acceptability, and preliminary effects of a 12-week combined physical activity and relaxation intervention for sedentary, early stage breast cancer survivors after completing all primary treatment.

Intervention Characteristics/Basic Study Process

Early stage breast cancer survivors participated in a 12-week combined physical activity (PA) and relaxation intervention, with baseline and 12- and 24-week assessments. Participants received a theoretically grounded intervention modeled after on the “Moving Forward” intervention based on the principles of the transtheoretical model (TTM) and the social cognitive theory (SCT). Participants were instructed to do moderate-intensity level exercise with pre-/post stretching. The goal was to walk 30 minutes five times a week by the twelfth week of the intervention. The relaxation component included instruction on progressive muscle relaxation (PMR); a CD with PMR instructions was included. Participants were telephoned weekly to provide counseling, a review of their practice activities, reinforcement, identification of barriers, and negation of the next week's goals.

Sample Characteristics

  • The sample was comprised of 23 women.
  • Mean age was 52.5 years (standard deviation = 8.4 years).
  • Most participants were diagnosed with stage I or II, nearly two years prior.
  • The majority were partnered, white, and non-Hispanic.
  • The sample was relatively well-educated, with most participants receiving at least some college education.

Setting

  • Multisite
  • Outpatient oncology clinics
  • East coast, United States

Phase of Care and Clinical Applications

  • Patients 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 prospective, single-arm, repeated measures design.

Measurement Instruments/Methods

  • Medical and demographic information obtained from self-report and medical record abstraction
  • Seven-Day Physical Activity Recall (7-Day PAR)    
  • Pittsburgh Sleep Quality Index (PSQI)
  • Stage of Motivational Readiness for PA
  • IM Systems-3 dimensional accelerometers (Biotrainer-Pro)
  • Profile of Mood States (POMS)
  • Intervention feasibility and acceptability assessed via a single item, 1–5 Likert score of satisfaction with the exercise portion of the program; or relaxation component

Results

Participant evaluations of the intervention indicated that it was feasible and acceptable (e.g., 100% would recommend it to others); objective data further supported its feasibility (e.g., 83% completed the trial, and 91% of the intervention calls were received). In addition, when comparing 12- and 24-week follow-up data to baseline data, participants demonstrated significantly increased PA, improved mood and sleep quality, and reduced fatigue (p < 0.05).

Conclusions

The pilot study suggested that the intervention is feasible, acceptable, and produces promising effects on mood, sleep, and fatigue.

Limitations

  • The study had a small sample size, with less than 30 participants.
  • The study lacked a control group.
  • The sample was racially and socioeconomically homogenous.
  • The eligibility criteria were conservative.  

Nursing Implications

Multibehavior interventions, such as exercise and relaxation, hold promise for cancer survivors and may improve quality of life (i.e., fatigue, sleep, mood, and disturbance).

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Rajotte, E. J., Yi, J. C., Baker, K. S., Gregerson, L., Leiserowitz, A., & Syrjala, K. L. (2012). Community-based exercise program effectiveness and safety for cancer survivors. Journal of Cancer Survivorship, 6, 219–228.

Study Purpose

To determine the effectiveness and safety of a disseminated community-based exercise program for cancer survivors who completed cancer treatment.

Intervention Characteristics/Basic Study Process

Twice weekly over a period of 12 weeks, YMCA personal trainers supervised groups of seven to 14 study participants during 90-minute exercise sessions at 13 YMCA sites. Study measures were administered at baseline and after the 12-week exercise program. The standardized protocol included aerobic warm-up (10 minutes), resistance training (50 minutes), and community building time (e.g., sharing personal experiences, didactic and experiential training in breathing, relaxation, stress management, and nutrition). Precautions or contraindicated movements were noted for each participant, and resistance training was individualized. YMCA personal trainers had at least one year of personal training experience and received a specialized 16-hour group training by a cancer rehabilitation physical therapist. Additional training to address emotional issues for participants and trainers was provided by a licensed clinical psychologist with expertise in cancer survivorship. Participants and immediate family received access to YMCA facility branches and were encouraged to exercise outside of the sessions.

Sample Characteristics

  • In total, 187 patients (17.6% male, 82.4% female) with both pre- and postintervention data were included. 
  • Mean age was 57.7 years (standard deviation [SD] = 10.3)
  • Patients had mixed cancers (55.5% breast cancer, 7.5% lymphoma, and 5% leukemia and prostate cancers).
  • Mean time since diagnosis was 5.6 months (SD = 6.9 months).
  • Eligibility included being off cancer treatment for longer than 90 days, with no evidence of active disease. Medical clearance was required to participate in the exercise program.  
  • Of the patients, 97.3% were Caucasian and non-Hispanic/non-Latino, 63.6% had completed four-year college or graduate school education, and 49.7% reported working full- or part-time for pay.

Setting

  • Multisite (13 YMCA sites as part of LIVESTRONG Exercise and Thrive [E & T] Program)
  • Community
  • Western Washington State

Phase of Care and Clinical Applications

Patients were undergoing long-term follow-up postcancer treatment.

Study Design

This was a prospective pre/post (nonrandomized) study design.

Measurement Instruments/Methods

Validated patient-reported outcomes measures included

  • Health-related quality of life: Short Form 36 Health Survey (SF-36), version 2
  • Fatigue: Fatigue Symptom Inventory (FSI)
  • Insomnia: Three items were developed for this study, rated from rarely or never (0) to nearly every day (4) for: “Does it take you more than half an hour to fall asleep at night?” “Do you wake during sleep and have difficulty falling back to sleep?” and “Do you wake earlier than you want in the morning and are you unable to get back to sleep?”
  • Physical activity level: SF-36, version 2, physical component summary
  • Physiologic measures:  six-minute walk test, resting heart rate, blood pressure, one repetition maximum test (upper and lower body strength), and sit and reach test (flexibility)
  • Muscle and joint problems: Muscle and Joint Measure with subscales assessed (1) muscle aches or stiffness (myalgias); (2) joint pain; (3) stiffness or swelling (arthralgias) and muscle cramps; and (4) muscle weakness
  • Social support:  brief seven-item measure used in the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) study (study testing a psychosocial intervention on patients with postacute myocardial infarction)
  • Injuries and/or lymphedema during classes:  Assessment was developed for the study using yes/no response items, including: “During your participation in E & T did you have any injuries?” and “As far as you know did you have any swelling or lymphedema that developed during E & T?” For those participants responding positive to the lymphedema question, subsequent questions were asked to determine if the lymphedema symptoms developed before or during the E & T program and (if lymphedema developed during the program) if the symptoms were a flare-up of existing lymphedema or a new site of lymphedema.
  • Program evaluation: Five items were developed for the study, including: “How satisfied are you with your participation in the program overall?,” “Were the staff leading the program competent and knowledgeable?,” and “How easy or difficult was it for you to participate in the program?.”

Results

The study indicated that the community-based exercise program has important beneficial effects on physiologic, symptom, and quality of life health outcomes for cancer survivors and is safe to implement. Findings suggested that the program is helpful for improving fatigue, insomnia, physical function, overall musculoskeletal symptoms, mental health, social support, and physical activity in cancer survivors. Average baseline insomnia ratings of 1.63 (SD = 0.93) differed significantly from postintervention ratings of 1.43 (SD = 0.85) (p < 0.001).  Additionally, the exercise program indicated notable improvements in physiologic measures (blood pressure, upper and lower body strength, walking endurance, and flexibility).

Conclusions

Community-based exercise groups for cancer survivors of mixed diagnoses and ages, who have completed active treatment, have physiologic and psychosocial benefits and appear to be safe. Because the participants self-selected to be part of the study and were screened for their ability to participate, findings cannot be generalized to the larger cancer survivor population.

Limitations

  • The study had a risk of bias due to no control group, no blinding, no random assignment, no appropriate attentional control condition, and the sample characteristics*.
  • Participant withdrawals were 10% or greater.
  • * Measurement validity/reliability was questionable. Findings were not generalizable. The intervention was expensive, impractical, and/or training needs. Participants were 82.4% female and non-Hispanic (Caucasian); the ethnic and racial homogeneity of the sample limited the generalizability of the findings. More than half of the participants had a breast cancer diagnosis. Self-referral and convenience sampling provided a population of participants who were motivated to self-initiate participation in an exercise program. Several measures were developed for the study, including the measure of insomnia; thus, there was a lack of previous established reliability and validity. Although access to the YMCA was provided to participants, the intervention was expensive in terms of participant time and effort, and personal trainers required special cancer-related training and one year of personal training experience. Having the intervention delivered to groups offsets the cost to a certain degree. Thirty-four of of 221 participants were excluded from the analysis because data were only available at one time point; there was a 15% withdrawal rate.

Nursing Implications

Survivors may benefit from participating in a community-based exercise program tailored to meet their individual needs as a survivor; however, exercise programs should be preceded by consultation with health care providers. Additional nursing research is needed to determine the effect of resistance training and other exercise protocols in more diverse cancer survivor populations.

Print

Rogers, L.Q., Vicari, S., Trammell, R., Hopkins-Price, P., Fogleman, A., Spenner, A., . . . Verhulst, S. (2013). Biobehavioral factors mediate exercise effects on fatigue in breast cancer survivors. Medicine and Science in Sports and Exercise, 46, 1077-1088.

Study Purpose

To examine mediators of fatigue effects of an exercise intervention

Intervention Characteristics/Basic Study Process

Patients were randomized to an exercise intervention or control group. The intervention combined walking and strength training with resistance bands. Walking was gradually increased by week 9 to 40 minute sessions of moderate intensity, four times per week, and participants attended 26 individual exercise sessions supervised by an exercise specialist. Resistance training was two times per week in the last 10 weeks of the study with the supervised aerobic walking sessions. Resistance was advanced as tolerated. Six group meetings with a psychologist also were provided every other week to provide support and improve exercise adherence. The control group was instructed to maintain usual exercise behavior.

Sample Characteristics

  • N = 42  
  • MEAN AGE = 56.2 years (SD = 7.7)
  • KEY DISEASE CHARACTERISTICS: All patients had breast cancer, were at least four weeks post-completion of primary treatment, had an average fatigue score of at least 3 in the past week, or had sleep dysfunction
  • OTHER KEY SAMPLE CHARACTERISTICS: Multiple chronic concurrent conditions were excluded

Study Design

  • RCT

Measurement Instruments/Methods

  • MTI actigraph
  • Fatigue Symptom Inventory
  • PROMIS general fatigue scale
  • PROMIS scales for depression, anxiety, and sleep/wake disturbance
  • Serum samples for interleukins (IL-6, -8, -10) and tumor necrosis factor alpha

Results

Adherence to supervised exercise sessions was 91%–93%. Exercise goals for at home were met in 65% of the weeks during the study. General fatigue declined significantly in the intervention group compared to controls (d = –0.49, p < .01). Fatigue interference (d = –0.38, NS) declined in the intervention group. Fatigue intensity increased in the intervention group and declined in controls (d = 0.3, NS). There were no significant differences in depression. Anxiety declined in the intervention group (d = –0.54, p < .05). Sleep/wake dysfunction declined in both groups over time, but more in the intervention group (d = –0.054, p < .01). Positive effects in fatigue intensity were significantly mediated by IL-6, IL-10, IL-6:IL-10, and TNF alpha:IL-10.

Conclusions

The exercise program used here showed a small to medium non-significant effect on fatigue intensity and interference, as measured in this study. Effects of exercise on fatigue were mediated by some cytokine system responses.

Limitations

  • Small sample (< 30)
  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Other limitations/explanation: Fatigue and sleep disruption measures at baseline were lower in the intervention group, although the difference was not statistically significant, these could have influenced the general trends shown in the study.

Nursing Implications

Although this study has limitations, findings do provide additional support for positive effects of exercise on cancer-related fatigue among cancer survivors. Findings here show evidence of potential effects through the cytokine system. Adherence to the exercise program in this study was very good, using a support group interaction and the combination of supervised exercise sessions and home-based exercise recommendations. This type of additional support may help many patients adhere to an exercise program.

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Rogers, L.Q., Courneya, K.S., Oster, R.A., Anton, P.M., Robbs, R.S., Forero, A., & McAuley, E. (2017). Physical activity and sleep quality in breast cancer survivors: A randomized trial. Medicine and Science in Sports and Exercise, 49, 2009–2015.

Study Purpose

The purpose was to determine the effects of a physical activity behavior change intervention compared to usual care on sleep quality in post-primary treatment breast cancer (BC) survivors.

Intervention Characteristics/Basic Study Process

Participants were randomized to a three-month, social cognitive theory-based Better Exercise Adherence after Treatment for Cancer (BEAT Cancer) behavior change intervention or usual care. BEAT Cancer included 12 supervised exercise sessions with exercise specialists during the first six weeks, followed by unsupervised home-based exercise supported by counseling sessions with exercise specialists every two weeks. Participants also completed 6 group discussion sessions with topics about exercise barriers and benefits, goal setting, behavioral modification, safety, relapse prevention, and exercise role models. The goal of BEAT Cancer was to complete ≥ 150 minutes of moderate-to-vigorous physical activity each week. Study measures were completed at three time points: baseline, immediately postintervention (month 3), and 3 months postintervention (month 6).

Sample Characteristics

  • N: 222 women with BC
  • AGE: Patients with BC M = 55.6 (SD = 9.0); healthy women M = 53.1 (SD 10.0)
  • FEMALES: 100%
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: History of ductal carcinoma in situ (DCIS) or stage I-IIIA BC, ≥ 8 weeks postsurgery and postprimary treatment (could be on longer-term treatments such as antiestrogen therapy) 
  • OTHER KEY SAMPLE CHARACTERISTICS: Reported average of ≤ 30 minutes of vigorous physical activity or ≤ 60 minutes of moderate activity per week during the past six months

Setting

  • SITE: Multisite   
  • SETTING TYPE: 3 academic institutions    
  • LOCATION: United States

Phase of Care and Clinical Applications

PHASE OF CARE: Transition (postprimary treatment, could be on hormonal therapy)

Study Design

Randomized controlled intervention trial with usual care control

Measurement Instruments/Methods

  • Pittsburgh Sleep Quality Index (PSQI)
  • MTI/Actigraph accelerometer models GT1M and GT3X (7 nights)

Results

The BEAT Cancer intervention significantly improved PSQI global sleep quality when compared with usual care at postintervention (mean between-group difference [M] = -1.4; 95% CI = -2.1 to -0.7; p < 0.001) and 3 months postintervention (M = -1.0; 95% CI = -1.7 to -0.2; P = .01), after adjusting for covariates. BEAT Cancer improved several PSQI subscales at postintervention (sleep quality M = -0.3; 95% CI = -0.4 to -0.1; p = 0.002; sleep disturbances M = -0.2; 95% CI = -0.3 to -0.03; p = 0.016; daytime dysfunction M = -0.2; 95% CI = -0.4 to -0.02; p = 0.027) but not 3 months postintervention. A nonsignificant increase in the percentage of participants classified as good sleepers was reported. No significant between-group difference was noted for accelerometer sleep latency or efficiency.

Conclusions

A social cognitive theory-based physical activity intervention reduced perceived global sleep disturbance at postintervention and 3 months postintervention compared to usual care, primarily related to improvements in various aspects of sleep quality. However, improvements were not detected with accelerometer.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Risk of bias (sample characteristics)
  • Unintended interventions or applicable interventions not described that would influence results
  • Measurement and methods not well described
  • Measurement validity and reliability questionable
  • Subject withdrawals ≥ 10%
  • Other limitations/explanation: No blinding, no attentional control group, lack of sample diversity, potential risk of intervention diffusion between groups, no reported participant withdrawals or protocol fidelity data 

Nursing Implications

Exercise adherence intervention may reduce perceived global sleep disturbance at 3 and 6 months postintervention. Additional exercise research in oncology is needed to optimize the use of physical activity in improving the health and well-being of cancer survivors through improved sleep.

Print

Sprod, L.K., Palesh, O.G., Janelsins, M.C., Peppone, L.J., Heckler, C.E., Adams, M.J., . . . Mustian, K.M. (2010). Exercise, sleep quality, and mediators of sleep in breast and prostate cancer patients receiving radiation therapy. Community Oncology, 7, 463–471.

Study Purpose

To assess the effect of home-based exercise on sleep quality and proinflammatory cytokines in patients with breast and prostate cancer receiving radiation therapy

Intervention Characteristics/Basic Study Process

Patients randomly were assigned to the home-based exercise or control group. Patients in the control group received standard care and were encouraged to remain only as active as they were prior to study inclusion. Patients in the intervention group were given 45 minutes of instruction by an exercise physiologist and given an exercise kit that contained written instructions, a pedometer, and resistance bands. The exercise prescription followed the American College of Sports Medicine guidelines for progressive walking at moderate intensity. Resistance band use was designed for low to moderate intensity, focusing on upper extremities. Patients wore pedometers during the first week. All patients were followed weekly for four weeks. Study measures were obtained at baseline and after the intervention.

Sample Characteristics

  • N = 38
  • MEAN AGE = 60.1 years (SD = 12.1 years)
  • MALES: 29%, FEMALES: 71%
  • KEY DISEASE CHARACTERISTICS: All had breast or prostate cancer and were in treatment with radiation therapy; none had recurrent disease or distant metastases.
  • OTHER KEY SAMPLE CHARACTERISTICS: 61% were married, 90% were Caucasian, 50% had previous chemotherapy, and 74% had at least some college education. Inclusion criteria included a sedentary lifestyle.

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • RCT
    • This report is a secondary analysis of the initial RCT.

Measurement Instruments/Methods

  • Pittsburgh Sleep Quality Index
  • ELISA for IL-6, TNF–α, and s-TNF-R

Results

Fifteen of the 19 patients in the exercise group reported increased daily steps walked and at follow-up at three months walked significantly more than patients in the control group (p < .05). Twelve of the 19 patients in the intervention group reported doing resistance training for an average of 17 minutes three days per week. Overall sleep quality improved over time in both groups, and no significant difference was seen between groups. Post-intervention levels of IL-6 and TNF-α increased slightly in both groups. Both of these were lower in the exercise group, but the difference was not significant.

Conclusions

These findings do not demonstrate an impact of a home-based exercise program on sleep quality.

Limitations

  • Small sample (less than 30)
  • Risk of bias (no blinding)
  • Unintended interventions or applicable interventions not described that would influence results
  • Other limitations/explanation: Although use of sleep medications is mentioned in the report, no data are provided regarding this or differences in other interventions between groups.

Nursing Implications

Findings show that patients being provided with training and materials to do a home-based exercise program was associated with good adherence by patients. However, findings did not show an effect of this exercise on sleep quality. Exercise is beneficial and should be encouraged but does not appear to have a beneficial effect on sleep-wake disturbance.

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Steindorf, K., Wiskemann, J., Ulrich, C.M., & Schmidt, M.E. (2017). Effects of exercise on sleep problems in breast cancer patients receiving radiotherapy: A randomized clinical trial. Breast Cancer Research and Treatment, 162, 489–499.

Study Purpose

The study goals were to (a) identify determinants of sleep disturbances in patients with breast cancer (BC) before radiotherapy, (b) determine the trajectory of sleep disturbances during radiotherapy and at 12-month follow-up, and (c) assess whether an exercise intervention could affect sleep trajectories.

Intervention Characteristics/Basic Study Process

The exercise intervention consisted of eight progressive resistance exercises (3 sets, 8–12 repetitions at 60%–80% of one repetition maximum). The relaxation control group did progressive muscle relaxation according to the Jacobson method. Both interventions were supervised and performed over approximately one hour twice weekly for 12 weeks along with other patients with cancer.

Sample Characteristics

  • N = 160 patients with BC; 25 controls (healthy women) 
  • AGE: Patients with BC M = 55.6 (SD = 9.0); healthy women M = 53.1 (SD = 10.0)
  • FEMALES: 100%
  • CURRENT TREATMENT: Radiation, other
  • KEY DISEASE CHARACTERISTICS: Stage 0-III primary BC after lumpectomy or mastectomy and scheduled for radiotherapy; 51% diagnosed in stage 1; 67.8 mean days since surgery 
  • OTHER KEY SAMPLE CHARACTERISTICS: Average BMI = 26.9 kg/m2; 21.3% had BMI ≥ 30; majority reported little engagement in exercise before BC diagnosis.

Setting

  • SITE: Single site    
  • SETTING TYPE: Hospital outpatient clinic     
  • LOCATION: Germany

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Prospective randomized controlled intervention trial with attention control (relaxation) and healthy control

Measurement Instruments/Methods

  • Fatigue Assessment Questionnaire (FAQ), a self-report (in past week) of global sleep assessment using a single item indicating sleep disturbance with a 4-point Likert scale
  • EORTC-QLQ-C30 insomnia subscale
  • Sleep-related characteristics: sleep duration (hours per night), number of awakenings per night, daytime napping (minutes), frequency per week of sleep problems (> 30 minute sleep onset, trouble staying asleep, too early awakenings) using 5 categories (never, 1-2 days, 3-4 days, 5-6 days, all days)  
  • Sleep measures were completed at 6 time-points: before intervention/radiotherapy (t0), after 6 weeks (t1), after 12 weeks (t2), and at 2, 6, and 12 months postintervention (t3, t4, t5).

Results

Higher prevalence of sleep disturbances were observed among patients with BC who had previous chemotherapy, higher BMI and depressive symptoms, previous hysterectomy, degenerative diseases, thyroid disorders, and higher symptom burden (hot flashes, pain, breast or arm problems, dyspnea). Patients with BC experienced higher levels of sleep disturbance at all times, but the trajectory of sleep disturbances in exercising women was similar to healthy women. The exercise intervention significantly decreased sleep disturbances compared to the relaxation control group on a 0–100 scale (between-group mean differences of -10.2; p = 0.03) from baseline to the end of radiotherapy and -10.9 (p = 0.005) to the end of the intervention). Sleep disturbances decreased in the exercise group and increased in the control group. At 12 months, differences were observed but not statistically significant (mean difference = -5.9, p = 0.20) even after adjusting for potential confounders.

Conclusions

This exercise intervention trial supports the findings of smaller studies that radiotherapy worsens sleep disturbances in patients with BC compared to healthy women. Findings suggest that a 12-week resistance training during radiotherapy can have positive effects on sleep disturbances during the treatment phase and even months after treatment completion.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (sample characteristics)
  • Measurement or methods not well described
  • Measurement validity or reliability questionable
  • Other limitations/explanation: Measurement or methods not well described in this secondary analysis of the “BEST” study (unable to determine sample demographics, blinding, and protocol fidelity in this publication or other referenced earlier publications)

Nursing Implications

Sleep quality is associated with quality of life in patients with cancer. These findings about determinants of sleep disturbance, the course sleep disturbance during radiotherapy, and the effect of an exercise intervention are of significance to many patients with BC.

Print

Swenson, K.K., Nissen, M.J., Knippenberg, K., Sistermans, A., Spilde, P., Bell, E.M., . . . Tsai, M.L. (2014). Cancer rehabilitation: Outcome evaluation of a strengthening and conditioning program. Cancer Nursing, 37, 162–169.

Study Purpose

To evaluate the effects of a supervised outpatient physical therapy strengthening and conditioning program on symptoms and quality of life

Intervention Characteristics/Basic Study Process

The program included aerobic exercise and strength training. The first two sessions were individualized under the supervision of a physical therapist. Patients who needed additional assistance walking, transferring, or using equipment continued to attend one-hour individual sessions. Patients were placed into 90-minute group sessions. The program consisted of intensive work for eight weeks, then six months of maintenance training was offered for those who were interested. Study assessments were done at baseline and after eight weeks.

Sample Characteristics

  • N = 75
  • MEAN AGE = 62.6 years (SD = 11.9 years)
  • MALES: 34.7%, FEMALES: 65.3%
  • KEY DISEASE CHARACTERISTICS: Various tumor types (breast and lung were most prevalent)
  • OTHER KEY SAMPLE CHARACTERISTICS: 34.7% metastatic disease; 15.3% in active treatment; 26.7% working full- or part-time

Setting

  • SITE: Single-site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Minnesota, United States

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care

Study Design

Quasi-experimental

Measurement Instruments/Methods

  • Short Form 36 (SF-36)
  • Six-Minute Walk Test (6MWT)
  • MD Anderson Symptom Inventory (MDASI)

Results

The results of the 6MWt were better on average at the end of eight weeks (p < 0.0001). Physical component scores on the SF-36 improved (p < 0.001) as did mental component scores after eight weeks (p < 0.005). At the end of six months, only physical component scores remained higher than reported at baseline. Fatigue (p = 0.003) and dyspnea (p = 0.007) were improved at eight weeks. After six months, fatigue (p = 0.0077), shortness of breath (p = 0.0005), and disturbed sleep (p = 0.045) were improved from baseline. Patients still in active treatment showed significantly less improvement. Those who showed the worst performance at baseline showed the greatest improvement.

Conclusions

The eight-week strengthening and conditioning program improved physical function, fatigue, dyspnea, and sleep disturbance in this study. Improvement was greatest among those who had the worst symptoms and physical performance statuses at baseline and among those who were not in active treatment.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Subject withdrawals ≥ 10%  
  • Other limitations/explanation: Greater than 30% of participants withdrew from the study. There were significant differences for individuals still in treatment; however, the sample was too small to adequately analyze study sample subgroups. No information was provided about other relevant interventions that may have occurred during the six months of follow-up.

Nursing Implications

The findings of this study demonstrated the effectiveness of an exercise program on symptoms of fatigue, shortness of breath, and sleep disturbance among a variety of patients with cancer. These findings add to the large body of evidence about the efficacy of exercise.

Print

Tang, M. F., Liou, T. H., & Lin, C. C. (2010). Improving sleep quality for cancer patients: benefits of a home-based exercise intervention. Supportive Care in Cancer, 18, 1329–1339.

Study Purpose

To determine the effect of a home-based walking exercise program on the sleep quality and quality of life (QOL) of cancer patients and to determine if enhanced sleep quality was associated with improvement in QOL over time.

Intervention Characteristics/Basic Study Process

Patients were recruited from oncology outpatient clinics in two university-based medical centers and were allocated to either usual care (n = 35) or a home-based walking exercise intervention for eight weeks (n = 36). The exercise intervention involved brisk walking for 30 minutes three times per week in the evening before supper, with a five-minute warm-up and five-minute cool-down. Questionnaires were delivered in interview format.

Sample Characteristics

  • The sample was comprised of 71 patients (24% male, 76% female).
  • Mean age was 51.80 years (standard deviation = 12.13 years).
  • Cancer sites included breast (n = 39), gastrointestinal (n = 11), nasopharyngeal (n = 7), lung (n = 4), and other (n = 10).
  • Of the patients, 74% were married, 32% were working, and 30% were receiving cancer treatment.
  • Mean time since diagnosis was 3.84 years.

Setting

  • Multisite
  • Outpatient
  • Hospital in Taipei, Taiwan

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

The study was a randomized, controlled trial.

Measurement Instruments/Methods

  • Pittsburgh Sleep Quality Index (PSQI), Taiwanese version
  • Medical Outcomes Study Short Form-36 (MOS-SF), Taiwanese version
  • Borg rating of perceived exertion (RPE) scale     
  • Walking exercise log

Results

Patients in the exercise group reported significant improvements in sleep quality (p < 0.01) at one and two months, and the mental health dimension of QOL; no change was reported in the control group. Physical components of QOL were also improved in the exercise group (p < 0.0001). Among patients who exercised, enhanced sleep quality also corresponded with reduced bodily pain and improvements over time in the mental health dimension of QOL.

Conclusions

A home-based walking exercise program can be easily incorporated into care for cancer patients who are suffering from sleep disturbances and may benefit sleep quality and aspects of QOL.

Limitations

  • The study had a small sample size, with less than 100 patients.
  • Confounders of sleep (environment, light exposure, and social factors) were not controlled.
  • Only subjective sleep data were collected.
  • The objective measure of physical activity was not collected, and additional physical activity, apart from the walking intervention, was not measured.
  • The short follow-up did not provide information about whether patients continued adherence to the walking program, and the benefits.  

Nursing Implications

A home-based exercise program appears promising for improving sleep quality and QOL for cancer patients that can easily be incorporated into care, but further study is warranted with more objective measures and measurement of potential confounding variables.

Print

Wang, Y. J., Boehmke, M., Wu, Y. W., Dickerson, S. S., & Fisher, N. (2011). Effects of a 6-week walking program on Taiwanese women newly diagnosed with early-stage breast cancer. Cancer Nursing, 34, E1–E13.

Study Purpose

To examine the effectiveness of an exercise program on quality of life (QOL), fatigue, sleep disturbances, exercise self-efficacy, exercise behavior, and exercise capacity in women with breast cancer.

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to an exercise or usual care group. The exercise intervention was a six-week walking program based on modified exercise guidelines of the American Cancer Society and American College of Sports Medicine. This program included use of a heart rate ring monitor, pedometer, weekly telephone call, weekly meetings, and an exercise diary. Exercise was of low to moderate intensity (40%–60% maximum heart rate). In this program, patients did weekly goal setting and were given advice and information, and several specific strategies were described that were intended to boost self-efficacy. Patients were oriented to the exercise program prior to surgery, and exercise was begun within a few days after surgery. Data were collected 24 hours prior to surgery and at 24 hours prior to the first cycle of chemotherapy, 7 to 10 days after chemotherapy, and at the end of six weeks.

Sample Characteristics

  • The sample was comprised of 62 women. 
  • Mean age was 50.42 years (standard deviation = 9.64 years).
  • All patients had undergone mastectomy.
  • Of the patients, 36% had at least a college education, 80.6% were married, and 51.4% were working full-time.
  • All patients had stage I or II disease and were newly diagnosed.

Setting

  • Single site
  • Outpatient
  • Taiwan

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

The study was a randomized, controlled trial.

Measurement Instruments/Methods

  • Functional Assessment of Cancer Treatment–General and Fatigue scales (FACT-G, FACT-F)
  • Pittsburgh Sleep Quality Index (PSQI)
  • Exercise Self-Efficacy Scale (EXSE)
  • Godin Leisure-Time Exercise Questionnaire
  • 6-minute walk test (6MWT)

Results

The pattern of change in QOL over time showed significant consistent improvement among those in the exercise group compared to usual care controls (p < 0.001). Patterns of change in sleep and sleep disturbance also showed significant improvement over time compared to controls (p < 0.006). The pattern of fatigue showed higher fatigue levels in the exercise group at all study time points. Average fatigue scores changed from 40.5 to 45.8 at week 6 in the exercise group and from 40.1 to 40 with usual care. Patients in the exercise group had significantly better exercise self-efficacy (p ≤ 0.001) and higher levels of exercise behavior (p < 0.001) than those receiving usual care. Patients in the exercise group walked farther on the 6MWT than controls after the intervention (p ≤ 0.001).

Conclusions

Findings showed that a self-managed home exercise program, along with intervention strategies aimed at boosting self-efficacy, had a positive effect on QOL and exercise behavior among women newly diagnosed with breast cancer.

Limitations

  • The study had a small sample size, with less than 100 patients.
  • It is not clear what type of relevant patient information and education was provided in the usual care group.
  • The duration of the study was relatively short at six weeks.
  • The sample was very slightly underpowered.
  • Lack of any blinding suggests a potential for bias.
  • It is not clear if both groups received weekly telephone calls so that attentional control was provided.
  • There was a 30% contamination rate, with 30% of control group patients also exercising at least three times per week.

Nursing Implications

The findings did not show a positive impact of a home-based exercise self-efficacy intervention on fatigue in the first six weeks after surgery in newly diagnosed patients. However, over a longer period of time, patients in the exercise group did better. Nurses may need to educate patients that adherence to an exercise program may not show results in the short term and that effects may take some time to be felt. Nurses can educate and encourage patients to exercise at home, and support activities to boost patient sense of efficacy may improve patient adherence to an exercise prescription.

Print

Wenzel, J. A., Griffith, K. A., Shang, J., Thompson, C. B., Hedlin, H., Stewart, K. J., . . . Mock, V. (2013). Impact of a home-based walking intervention on outcomes of sleep quality, emotional distress, and fatigue in patients undergoing treatment for solid tumors. The Oncologist, 18, 476-484.

Study Purpose

To evaluate the impact of a home-based walking program on patient symptoms of fatigue, sleep disturbances, and mood.

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to the walking program or a usual care control group. The exercise intervention included a walking prescription based on the American College of Sports Medicine guidelines. The targeted exercise prescription included a brisk 20- to 30-minute walk with five-minute warm-ups and cool-downs five days per week. Exercise participants wore pedometers. Usual care patients wore pedometers during the first two weeks only. Throughout the study, patients in both groups received telephone contact on a biweekly basis to discuss physical activity and any concerns. For those in the exercise program, adjustments to the program were made, barriers to walking were discussed, and strategies for resolution were planned.

Sample Characteristics

  • One hundred twenty-six patients (61.1% male, 38.9% female) were included.  
  • Mean age was 60.2 years (range 28–80).
  • Patients had multiple solid tumor types; the most common were prostate, breast, and colorectal tumors.
  • All patients were scheduled to receive chemotherapy or radiation therapy.
  • Of the patients, 78.6% were Caucasian and 84.9% were married or partnered.

Setting

  • Single site 
  • Home 
  • New Jersey

Phase of Care and Clinical Applications

Patients were undergoing the active antitumor treatment phase of care.

Study Design

This was a randomized, controlled trial.

Measurement Instruments/Methods

  • Piper Fatigue Scale (PFS)
  • Profile of Mood States (POMS)
  • Cooper Aerobics Center Longitudinal Study
  • Physical Activity Questionnaire (PAQ) for exercise dose
  • Pedometer
  • Pittsburgh Sleep Quality Index (PSQI)
  • Daily exercise and symptom log

Results

Analysis of dropouts showed that significantly more ethnic minorities and those with lower educational levels withdrew (p < 0.03). There were no differences at the end of the study in sleep quality. There were no differences between groups in overall mean emotional distress scores; however, dose-response analysis showed that those who exercised more had less emotional distress (p = 0.03). There were no between-group differences in fatigue; however, analysis showed that those who exercised more had lower fatigue scores (p = 0.03). Subgroup analysis among patients with prostate cancer showed that exercise group members had better sleep quality (p < 0.001), less emotional distress (p = 0.048), and less fatigue (p = 0.009). PAQ findings were moderately correlated with pedometer results, suggesting that the PAQ may be a reasonable measure of exercise dose (Spearman = 0.37; p = 0.002).
 

Conclusions

Findings suggested that a home-based exercise program can be beneficial in patients receiving cancer treatment to reduce fatigue. Among patients with prostate cancer, the program resulted in improved sleep quality and less emotional distress and fatigue.

Limitations

  • The study had a risk of bias due to no blinding.
  • Patient withdrawals were 10% or greater.

Nursing Implications

A home-based walking program is a simple intervention that can be beneficial to patients, and study findings showed that patients who exercised more had less fatigue and improved mood. In patients other than patients with prostate cancer, it did not appear that exercise improved sleep quality. This study included biweekly telephone follow-ups. Other studies have not shown the same level of results with home-based walking, suggesting that the follow-up component is probably important to maintain patient exercise program use. Of interest, patients who were less educated and of ethnic minorities were more likely to drop out of the study. This suggests that these groups of patients need to be examined more in order to see what interventions will be most likely to appeal to them.

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Young-McCaughan, S., Mays, M. Z., Arzola, S. M., Yoder, L. H., Dramiga, S. A., Leclerc, K. M., . . . Nowlin, M. U. (2003). Research and commentary: change in exercise tolerance, activity and sleep patterns, and quality of life in patients with cancer participating in a structured exercise program. Oncology Nursing Forum, 30, 441–454; discussion 441–454.

Intervention Characteristics/Basic Study Process

Patients met twice a week for 12 weeks for exercise and education. Outcomes were exercise tolerance, activity, sleep, and quality of life (QOL).

Sample Characteristics

  • The sample was comprised of 62 patients (31 men, 31 women).
  • Mean age was 55 years.
  • Patients had mixed ethnicity and varying cancer diagnoses and stages.
  • Therapy included surgery, chemotherapy, radiotherapy, immunotherapy, and endocrine and hormonal therapy.

Setting

  • Two major military medical centers
  • Inpatient and outpatient
  • Southwestern United States

Phase of Care and Clinical Applications

Patients were either undergoing the active treatment or long-term follow-up phase of care.

Study Design

This was a prospective, feasibility study with repeated measures.

Measurement Instruments/Methods

  • Wrist actigraphy to measure the duration of sleep, percentage of night spent asleep, average length of a sleep episode, and number of awakenings.
  • Cancer Rehabilitation Evaluation System–Short Form (CARES-SF) sleep item

Results

No improvement was found in sleep patterns per actigraphy; improved subjective rating was noted.

Limitations

  • This was a feasibility study; therefore, no control group was used.
  • The study had a small sample size.
  • Actigraphy data were missing.
  • Cost is incurred for actigraphs.
  • Staff must be trained in the exercise measurement.
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