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Bertheussen, G.F., Kaasa, S., Hokstad, A., Sandmæl, J.A., Helbostad, J.L., Salvesen, Ø., & Oldervoll, L.M. (2012). Feasibility and changes in symptoms and functioning following inpatient cancer rehabilitation. Acta Oncologica, 51, 1070–1080. 

Study Purpose

To assess feasibility and effects of an inpatient rehabilitation program on symptoms and physical function

Intervention Characteristics/Basic Study Process

Participants attended three weeks of inpatient rehabilitation and a follow-up five-day stay 8–12 weeks later. All attended group programs, which included physical training and education following cognitive behavioral approaches. Physical training was done twice a day for 60–120 minutes.

Sample Characteristics

  • N = 131
  • AGE: 14% were 25–44 years old, 86% were greater than or equal to 45
  • MALES: 23%, FEMALES: 77%
  • KEY DISEASE CHARACTERISTICS: Participants had multiple tumor types, although breast and GI were most common.
  • OTHER KEY SAMPLE CHARACTERISTICS: All had high school education, and 66% had some college education. Time since diagnosis was less than two years in 72%. Thirty percent were working full-time or part-time.

Setting

  • SITE: Single site  
  • SETTING TYPE: Inpatient  
  • LOCATION: Norway

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care

Study Design

  • Quasiexperimental

Measurement Instruments/Methods

  • EORTC Cancer Quality of Life Core 30 (EORTC–QLQ-C30) questionnaire
  • Fatigue questionnaire
  • Physical activity questionnaire
  • Maximal oxygen consumption test (Vo2 max test)
  • Sit-to-Stand Test (SST)
  • Maximum step length

Results

Multiple symptoms showed decline. These were statistically significant; however, the degree of change seen from the end of the initial three weeks to the final measure was less than that which the authors identified as clinically relevant. Fatigue scores increased from baseline to postintervention measures (8.9–9.3 for physical fatigue and 4.9 for mental fatigue at both time points). All symptoms declined from baseline over time.

Conclusions

Findings suggest that a multicomponent rehabilitation program can improve multiple symptoms for patients with cancer.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Risk of bias (sample characteristics)
  • Subject withdrawals of 10% or greater 
  • Dropouts tended to be those with lower education levels, and significantly more males dropped out.
  • The sample was self-selected.
  • Lack of a control group does not enable determination if changes seen were due only to time, as it is known that many symptoms decline over time. 
  • Authors noted that the three-week program was very resource intensive.  

Nursing Implications

Findings showed improvement of multiple symptoms after a three-week inpatient rehabilitation program. This was resource intensive and had many dropouts, causing one to question the practicality and cost-effectiveness of this approach. This study is limited by its design, with lack of a control group.

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Bertheuil, N., Sulpice, L., Levi Sandri, G.B., Lavoue, V., Watier, E., & Meunier, B. (2015). Inguinal lymphadenectomy for stage III melanoma: a comparative study of two surgical approaches at the onset of lymphoedema. European Journal of Surgical Oncology, 41, 215–219.

Study Purpose

To compare the difference in occurrences of lymphedema and other postoperative complications following two different surgical approaches for stage 3 melanoma

Intervention Characteristics/Basic Study Process

Researchers divided patients into two groups, one that received vertical incisions, and another that received transverse incisions. Taking into account individual variables and any postoperative issues, patients were retrospectively studied for the presence of lymphedema.

Sample Characteristics

  • N = 53  
  • AVERAGE AGE = 52.79 years
  • MALES: 45% (rounded up), FEMALES: 55% (rounded up)
  • KEY DISEASE CHARACTERISTICS: Histologic type of melanoma; Breslow's depth; Clark's level; ulceration and regression
  • OTHER KEY SAMPLE CHARACTERISTICS: The presence of lymphedema, personal characteristics (i.e., height, weight, age, sex, body mass index, smoking status), skin necrosis, wound separation or infection, and seromas were taken into account.

Setting

  • SITE: Single site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Centre Hospitalier Universitaire, Rennes, France

Phase of Care and Clinical Applications

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

Study Design

Retrospective chart review

Measurement Instruments/Methods

  • Lymphedema was considered present or not present according to medical charts.
  • There was no specific description of how lymphedema was measured or graded.

Results

No statistically significant difference was noted between the two groups regarding any variable or characteristics, including the primary lymphedema status.

Conclusions

The difference in surgical approach didn't influence surgical outcomes, potential complications, or potential for chronic lymphedema.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (no control group) 
  • Risk of bias (no random assignment)
  • Risk of bias (sample characteristics)
  • Key sample group differences that could influence results
  • Measurement/methods not well described
  • Measurement validity/reliability questionable
 

 

Nursing Implications

This study did not have a direct effect on nursing practice other than to help inform nurses about the low potential for surgical approaches to have a negative effect on outcomes.

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Bertelli, G., Venturini, M., Del Mastro, L., Bergaglio, M., Sismondi, P., Biglia, N., … Rosso, R. (2002). Intramuscular depot medroxyprogesterone versus oral megestrol for the control of postmenopausal hot flashes in breast cancer patients: A randomized study. Annals of Oncology, 13, 883–888.

Study Purpose

The study was designed to compare injected medroxyprogesterone vs. oral megestrol to control hot flashes in women with breast cancer.

Intervention Characteristics/Basic Study Process

Participants were randomized to two groups. Group 1 received I.M. depot MPA (500 mg on days 1, 14, and 28) and Group 2 received oral megesterol acetate (40 mg po daily days 1-42).

Sample Characteristics

Eligible patients were postmenopausal females with a history of breast cancer, without evidence of relapse, whom had been suffering from hot flashes for at least 1 month prior to study entry. Group 1 enrolled 3 , and Group 2 enrolled 34.  Major Inclusion/Exclusion Criteria:

  • Concurrent adjuvant tamoxifen 20 mg/day was allowed if started at least 1 month before study entry and if the planned residual duration of treatment was at least 6 months.
  • No concurrent treatment with estrogens, androgens, progestins, corticosteroids, clonidine, veralipride, or ciclophenile was allowed.
  • Patients who had received adjuvant chemotherapy had to have concluded treatment for more than 2 months.

Setting

Not described

Measurement Instruments/Methods

The primary endpoint was the proportion of responding patients after 6 weeks of treatment (7 weeks after randomization). A patient was classified as a responder if she achieved a greater than 50% reduction in frequency of hot flashes and hot flash score. Frequency and severity of hot flashes were monitored through self compiled diaries. The three main efficacy parameters were:

  1. Changes in average number of hot flashes per day
  2. Average daily ‘hot flash score’ compared to baseline
  3. Proportion of participants who obtained greater than 50% reduction in frequency and reduction in HF score as compared to baseline score

Results

The mean number of hot flashes and hot flash scores did not differ significantly at baseline between the two groups. Differences between the two groups at week six were not statistically significant. Good control by both treatments was apparent. No significant difference in the proportion of responders between the two arms was observed (p=0.567) Overal,l 50 of 71 patients (70.4%, 95% CI 58-81%) achieved a response as previously defined.Maintenance of response in the group of 50 initial responders was assessed at 2-monthly follow up visits for 6 months after randomization. By patient report, a difference in the duration of response was observed: out of 28 responding patients in the MPA group, 25 (89.3%) were still responding at 6 months. In the megestrol group, only 10 of the initial 22 responders (45.4%) were still in response after 6 months.

Limitations

For an 80% power and two sided 5% significance, 90 subjects were planned. Only 71 were accrued. After randomization, five patients in each group refused to start the assignment and withdrew from the study. Two more patients, both in group one, were found ineligible (one for medical contraindication and one not postmenopausal) and withdrawn. Six patients did not provide complete diary recordings during treatment (five patients who dropped out before completion for side effects and one who was lost to follow-up). Treatment allocation was not double-blinded because this would have required administration of I.M. placebo in group 2 which was judged impractical.

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Berry, S., Waldron, T., Winquist, E., & Lukka, H. (2006). The use of bisphosphonates in men with hormone-refractory prostate cancer: A systematic review of randomized trials. The Canadian Journal of Urology, 13(4), 3180–3188.

Purpose

To review results of published randomized controlled trials (RCTs) and meta-analyses to determine the benefits that bisphosphonates provide to men with hormone-refractory prostate cancer

Search Strategy

  • Databases searched were MEDLINE, EMBASE, CANCERLIT, and the Cochrane Library. Investigators also retrieved selected conference proceedings. The date range searched, for all materials, was 1980–2004.
  • Search keywords were text words and medical subject headings that were disease specific, treatment specific, and study-design specific.
  • Studies were included in the review if they
    • Were RCTs or meta-analyses.
    • Involved a sample of men with hormone-refractory prostate cancer and compared bisphosphonate treatment with placebo, no treatment, or treatment with another bisphosphonate.
    • Reported outcomes regarding new bone metastases, skeleton-related events, symptom response, survival, or quality of life.

Literature Evaluated

  • Authors did not report total number of search results.
  • Authors identified 17 reports as eligible.
  • Authors stated quality characteristics of evaluated studies, but did not report quantitative grading.

Sample Characteristics

The final sample of 17 reports included three systematic reviews and 12 RCTs. The sample included 1,446 patients. The range of sample size was 13–643. Eight trials supplied pain outcomes, and these eight trials involved 756 patients.

Results

Variability of pain measurement across studies prevented statistical pooling. Overall, trials did not detect significant differences in pain outcomes between patients taking the study drug and patients taking placebo. However, over a relatively long period and among individuals with at least moderate pain severity at baseline, authors noted trends toward better pain relief with bisphosphonates than with placebo. Most trials were identified as underpowered, a fact that may have prevented investigators from detecting significant differences. In general, patients tolerated bisphosphonates well. Nausea was the most frequently reported adverse event; across trials 9%–33% of patients experienced nausea.

Conclusions

Overall, trials reviewed did not show significant differences in pain outcomes between those who received bisphosphonates and those who received placebo. However, at specific time points subgroups of bisphosphonate-using patients who had at least moderate pain showed trends toward improvement.

Nursing Implications

Findings suggest that bisphosphonates may be helpful in providing pain relief to men with hormone-refractory prostate cancer who have at least moderate pain levels. Clinicians should watch for nausea in bisphosphonate-using patients and be ready to provide relief. Further research, to define the most effective timing of bisphosphonate administration and the best way to use a bisphosphonate alone or in combination with other therapies, is warranted.

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Berrak, S.G., Ozdemir, N., Bakirci, N., Turkkan, E., Canpolat, C., Beker, B., & Yoruk, A. (2007). A double-blind, crossover, randomized dose-comparison trial of granisetron for the prevention of acute and delayed nausea and emesis in children receiving moderately emetogenic carboplatin-based chemotherapy. Supportive Care in Cancer, 15, 1163–1168. 

Study Purpose

To compare tolerance for and the efficacy of granisetron at 10 µg/kg versus 40 µg/kg for the prevention of acute and delayed nausea and vomiting in patients receiving moderately emetogenic chemotherapy

Intervention Characteristics/Basic Study Process

Each patient was randomly assigned to receive either 10 µg/kg or 40 µg/kg of granisetron during alternating cycles of chemotherapy. Medication was given intravenously 30 minutes prior to the start of chemotherapy, and patients received no other prophylactic antiemetic medication. The dose was blinded from treating doctors, nurses, and patients. Data were collected the first five days following chemotherapy.

Sample Characteristics

  • N = 18
  • MEAN AGE = 7.7 years (range = 1–23 years)
  • MALES: 13 (72%), FEMALES: 5 (28%)
  • KEY DISEASE CHARACTERISTICS: All had optic pathway tumors
  • OTHER KEY SAMPLE CHARACTERISTICS: Scheduled to receive either carboplatin alone or carboplatin with vincristine

Setting

  • SITE: Single site    
  • SETTING TYPE: Inpatient    
  • LOCATION: Marmara University Medical Center in Istanbul, Turkey

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Pediatrics

Study Design

Randomized, double-blinded crossover trial

Measurement Instruments/Methods

  • Nausea and emesis were recorded by patients and parents on self-reported diary cards that were scored as a 1 (complete response [absence of nausea or vomiting]), 2 (major response [one emesis episode or moderate nausea]), 3 (minor response [two to four emesis episodes independent of nausea]), or 4 for (treatment failure [more than four emesis episodes per day]).
  • A safety assessment included any report of an adverse event by patients or parents and vital signs recorded by the physician.

Results

Antiemetic efficacy scores were not different between the two doses (1.045 for the 40 µg/kg dose and 1.040 for the 10 µg/kg dose [p = 0.330]). Neither gender nor age affected antiemetic efficacy scores. No granisetron-related side effects were reported. No patients withdrew from the study.

Conclusions

Granisetron was an effective antiemetic medication for moderately emetogenic chemotherapy with the majority of patients experiencing a complete antiemetic response over five days postchemotherapy. Higher doses of granisetron were associated with no significant improvements in efficacy. Granisetron was safe with no adverse events associated with administration.

Limitations

  • Small sample (< 30)
  • Measurement/methods not well described

Nursing Implications

Granisetron was a safe and effective medication that prevented acute and delayed nausea and vomiting associated with moderately emetogenic chemotherapy.

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Bergmann, A., da Costa Leite Ferreira, M.G., de Aguiar, S.S., de Almeida Dias, R., de Souza Abrahao, K., Paltrinieri, E.M., . . . Andrade, M.F. (2014). Physiotherapy in upper limb lymphedema after breast cancer treatment: A randomized study. Lymphology, 47, 82–91.

Study Purpose

To compare the effects of physical treatment with and without manual lymphatic drainage (MLD) on lymphedema in breast cancer survivors after lymphadenectomy

Intervention Characteristics/Basic Study Process

Patients were randomized into three groups. Group 1 received MLD, skin care, bandaging, and remedial exercises. Group 2 received soft touch (a sliding touch on chest and upper limbs), skin care, bandaging, and remedial exercises. Group 3 received skin care, bandaging, and remedial exercises. Groups 2 and 3 were combined after an initial analysis revealed no differences, and additional patients were randomized into the two groups. A physiotherapist trained in lymphedema therapy administered treatments three times per week to all patients in two phases. In phase 1, all patients received skin care, compressive bandaging, and remedial exercises, and group 1 received 30 minutes of MLD using the Vodder technique while group 2 did not receive any MLD. When arm volume plateaued for one week, patients from both groups moved to phase 2, which consisted of skin care, exercises, and fitted garments. Volume was assessed at randomization, after each treatment session, and at each follow-up visit. For both groups, phase 1 lasted approximately 24 days.

Sample Characteristics

  • N = 57  
  • AVERAGE AGE = 62 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Most participants were overweight (body mass index mean = 29.75).

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late effects and survivorship

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Volume was measured using the truncated cone formula with circumferences at 7, 14, and 21 cm under and 7 and 14 cm above the cubital fold
  • Volume excess
  • Absolute volume excess

Results

Patients in group 1 completed phase 1 in an average of 21.54 days, and patients in group 2 completed it in an average of 27.34 days. A significant reduction in limb volume was seen during phase I for both groups (p < .001), but no difference was seen between the groups. Patients in groups 1 and 2 had an average volume excess reduction of 15.02%. In both groups, 73.7% of participants reported subjective feelings of improvement in swelling.

Conclusions

The results of this study do not support the addition of MLD to treatment protocols for lymphedema after breast cancer. Patients in both groups of this study showed a statistically significant reduction in total arm volume after phase 1, and there were no differences in arm volume reduction between groups. Patients in group 1 did complete phase 1 in fewer days than patients in group 2.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)

 

Nursing Implications

This study does not support the use of MLD to treat lymphedema in breast cancer survivors after lymphadenectomy. Nurses should regularly assess patients who have completed breast cancer treatment for lymphedema and should provide appropriate referrals for treatment, give education about completing exercises at home, advise patients about wearing compression garments, and explain how to properly conduct skin care for a limb affected by lymphedema.

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Berglund, G., Petersson, L. M., Eriksson, K. C., Wallenius, L., Roshanai, A., Nordin, K. M., . . . Häggman, M. (2007). \"Between Men\": a psychosocial rehabilitation programme for men with prostate cancer. Acta Oncologica, 46, 83–89.

Intervention Characteristics/Basic Study Process

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

Sample Characteristics

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

Setting

University hospital in Uppsala, Sweden, Regional Oncological Centre

Phase of Care and Clinical Applications

Participants were undergoing the active treatment phase of care.

Study Design

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

Measurement Instruments/Methods

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

Results

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

Limitations

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

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Berglund, G., Petersson, L-M., Eriksson, K.C., Wallenius, I., Roshanai, A. Nordin, K.M., . . . Häggman, M. (2007). “Between Men”: A psychosocial rehabilitation programme for men with prostate cancer. Acta Oncological, 46, 83–89.

Study Purpose

To evaluate the effect of psychosocial rehabilitation on patients newly diagnosed with prostate cancer

Intervention Characteristics/Basic Study Process

Patients enrolled in the “Between Men” program were randomized to one of four groups. Each intervention group met for seven sessions. The group that received physical training participated in 60-minute sessions of light physical training that included movement, fitness training, relaxation, and breathing exercises. The group that received informationattended a 60-minute session about prostate cancer, treatment, side effects, etc. The \"combination\" group participated in exercise and received information, for a total of 135 minutes. The control group received standard care. Investigators asked four research questions, including whether physical training reduces depression among men with prostate cancer.

Sample Characteristics

The sample included 158 patients who had been newly diagnosed with prostate cancer.

Setting

  • Single site
  • Uppsala, Sweden

Study Design

Randomized controlled trial (RCT)

Measurement Instruments/Methods

  • Hospital and Anxiety Depression Scale (HADS)
  • EORTC Cancer Core Quality of Life (EORTC QLQ-C30) questionnaire
  • A cancer-specific multidimensional tool with subscales of functioning and symptoms

Results

This RCT did not find any differences in depression or anxiety symptoms among participants at the preintervention, 6-month, or 12-month assessment. The group that received physical training appeared to have experienced the most improvement in symptoms of depression. This improvement occurred between baseline and 12 months, but the confidence intervals overlapped too much for the improvement to be conclusive.

Limitations

  • Possibly ineffective intervention diminished control over activity and information in the control group.
  • Of all participants, 20% dropped out after 12 months.
  • The sample lacked heterogeneity among participants, and the size of each group was small; therefore, the study has limited generalizability.
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Berger, A. M., Kuhn, B. R., Farr, L. A., Von Essen, S. G., Chamberlain, J., Lynch, J. C., & Agrawal, S. (2009). One-year outcomes of a behavioral therapy intervention trial on sleep quality and cancer-related fatigue. Journal of Clinical Oncology, 27, 6033–6040.

Study Purpose

To determine the effects of a behavioral therapy (BT) sleep intervention (individualized sleep promotion plan [ISPP]) on cancer-related fatigue over a one-year period in women receiving adjuvant chemotherapy for breast cancer.

Intervention Characteristics/Basic Study Process

Patients at each study site were stratified according to number of planned anthracycline-based treatments and good versus poor sleep quality. Patients were then randomly assigned to the ISPP group or a control group that received care regarding health eating (HEC), which received the same amount of individual time and attention as the ISPP group. At baseline, patients in the ISPP group spent 90 minutes with the research nurse to develop a 12-item ISPP plan. Two days before all treatments, they spent another 30 minutes with the research nurse revising the plan based on sleep diaries and plan adherence data. After each revision, plans were reinforced in a 15-minute, in-person session seven to nine days after the revision. Plans included

  • Stimulus control
  • Modified sleep restriction
  • Relaxation therapy
  • Sleep hygiene counseling.

Thirty-minute sessions were held to revise the BT plan again at 30, 60, and 90 days after the last chemotherapy treatment. HEC participants received in-person sessions of equal time and attention before each treatment and at 30, 60, and 90 days after the completion of chemotherapy.

Sample Characteristics

  • In total, 217 patients (100% female) completed the study and were analyzed.
  • Mean age was 52.14 years (range 29–83).
  • All patients had breast cancer.
  • All patients were receiving adjuvant chemotherapy.
  • In each group, 14% of the patients had a cancer stage above II, at IIIA.
  • Of the patients, 75% had at least some college education.
  • The majority of patients were employed outside the home.
  • Patients were excluded if they had a self-reported comorbidity associated with poor sleep and fatigue.

Setting

  • Multi-site
  • Twelve oncology clinics

Study Design

This was a randomized, controlled trial with a one-year follow-up.

Measurement Instruments/Methods

  • Symptom Experience Scale (SES) to measure distress experiences of nausea, pain, appetite, bowel pattern, concentration, and appearance
  • Hospital Anxiety and Depression Scale (HADS)
  • Medical Outcomes Study Short Form 36 General Health Survey, version 2 (MOS-SF 36-v2)
  • Piper Fatigue Scale:  22-item scale, Crohnbach’s alpha = 0.93-0.98
  • Pittsburgh Sleep Quality Index (PSQI):  Crohnbach’s alpha = 0.74-0.83
  • Daily sleep diary
  • Wrist actigraph to quantify continuous monitoring of body movement for total sleep time after onset and sleep efficiency:  percent of time asleep after falling asleep out of total time in bed, number of awakenings, and time and percent of time awake after sleep onset

Results

The BT group had a significant improvement in sleep quality compared to the HEC group at 90 days (p = 0.002) but not at one year (p = 0.052). Higher fatigue (p = 0.027) and higher anxiety (p = 0.012) at baseline were associated with poorer sleep at one year. There were no differences in most diary and objective sleep findings at selected times over the year. Sleep diary and actigraph findings did not coincide for either group. Values recorded in the diaries tended to show better sleep time and percent and lower numbers of awakenings than the actigraph findings. Moderate to severe fatigue was reported at one year by 20% of patients in the BT group and 24% in the HEC group. Fatigue changed over time for both groups, but there were no significant differences between the groups. PSQI scores over time were significantly better in the BT group (p = 0.013).

Conclusions

The BT intervention improved global sleep quality but did not improve fatigue in women over a period of one year. Baseline anxiety was associated with higher fatigue and poor sleep at one year.

Limitations

  • Participants had relatively mild sleep disruptions at baseline, which may have limited the effect and effect size of the sleep and fatigue scores.
  • Differences in patient perception by diary and actigraph findings were not explained.
  • The coscientist model used in the BT group incorporated participant freedom to design their own BT plan. A drawback of this approach was that patients often chose strategies with easier habits to alter than those that might be most effective.
  • There was limited diversity in the sample demographics in terms of ethnicity and education level.
Print

Berger, A. M., Kuhn, B. R., Farr, L. A., Lynch, J. C., Agrawal, S., Chamberlain, J., & Von Essen, S. G. (2009). Behavioral therapy intervention trial to improve sleep quality and cancer-related fatigue. Psycho-Oncology, 18, 634–646.

Study Purpose

To determine the effect of behavioral therapy (BT)—specifically, an individualized sleep promotion plan (ISPP)—on sleep quality and fatigue in patients with breast cancer undergoing adjuvant chemotherapy.

Intervention Characteristics/Basic Study Process

Eligible women who consented to participate were randomized using stratified random sampling to either the BT group or to a healthy eating control (HEC) group prior to adjuvant chemotherapy. Patients completed questionnaires at baseline and wore a wrist actigraph for two days prior to initial treatment. Patients randomized to the BT group developed an ISPP during individual visits with the research nurse two days prior to treatment. Modifications to this plan were made two days prior to each treatment and 30 days after the last treatment. Modifications were based on patients' sleep diary data and treatment adherence. BT plans were reinforced during 15-minute sessions seven days after each revision. Patients in the HEC group received equal time and attention during individual visits and received information on healthy eating topics at each visit. Patients in the HEC group were referred to their treatment clinic for questions about fatigue and sleep.

Sample Characteristics

  • The study was comprised of 219 female patients with breast cancer.
  • Mean age was 52.13 years (range 29–79) in the BT group and 52.16 years (range 30–83) in the HEC group.
  • Patients had an initial diagnosis of stage I to IIIA breast cancer and had undergone either modified radical mastectomy or lumpectomy.
  • Of the patients, 70% were partnered and 74% had at least some college education.
     

Setting

The study was conducted in 12 oncology clinics in the Midwestern United States.
 

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

This was a randomized, controlled trial.

Measurement Instruments/Methods

  • Symptom Experience Scale (SES):  This scale measures frequency, intensity, and distress associated with six symptoms associated with cancer treatment. Scores for fatigue and sleep were not included in the mean SES score because they were measured in-depth by other study instruments.    
  • Hospital Anxiety and Depression Scale (HADS): This scale measures anxiety and depression symptoms.
  • Medical Outcomes Study Short-form General Health Survey (MOS-SF 36-v2):  The physical functioning subscale of this measure was used to measure physical functioning prior to cancer diagnosis.
  • Piper Fatigue Scale (PFS):  The PFS is a 22-item scale of subjective cancer-related fatigue. The PFS was used at each treatment because fatigue was expected to fluctuate from treatment to treatment. Higher scores on the PFS indicate worse fatigue. Reported internal consistency for this study was 0.93 to 0.98.
  • Pittsburgh Sleep Quality Index (PSQI):  The PSQI is a 19-item subjective measure of sleep quality over the past month. Seven component scores are summed to obtain global scores ranging from 0 to 21, with higher scores indicating greater sleep difficulties. In women with breast cancer, Cronbach’s alpha for global PSQI score is 0.80; it was 0.74 to 0.83 for this study.
  • Wrist actigraphy and daily diaries were used to measure sleep variables. The study used the Motionlogger® Actigraph with one-minute epochs. Variables included total sleep time after sleep onset, sleep efficiency, number of awakenings, and minutes and percent awake after sleep onset. Actigraphs were recorded 48 hours before the initial treatment, for seven days and nights during treatment and for seven days and nights 30 days after the last treatment.




     

Results

Mean PSQI scores in both groups were greater than five, which indicated poor sleep compared to the general population; however, mean scores were not greater than eight, a cutoff score associated with poor sleep quality in patients with breast cancer. Actigraphy and diary data showed normal sleep duration and sleep efficiency in both groups across treatment and follow-up. Number of awakenings after sleep onset measured by both sleep diaries and actigraphy were higher than normal in both groups. Significant differences between sleep diaries and actigraphy were observed for all sleep variables (p < 0.01 for all variables), with lower numbers of awakenings and higher sleep efficiency per diary data in the BT group. A significant group by time interaction was found for changes in the PSQI, with sleep quality improving in the BT group (p < 0.049). Although not significant, there were trends towards improved sleep quality over time in the BT group per actigraphy for total sleep time and number of awakening and per sleep diary for sleep efficiency. Perceived fatigue changed significantly over time in both groups (p < 0.001), with increased fatigue during treatments and decreased fatigue after the end of treatments in both groups. There was no apparent effect of BT on fatigue levels.

Conclusions

Patients in the BT group showed greater improvement in sleep quality over time than those in the the HEC group, although perceptions of improved sleep quality were not consistently associated with objective sleep measures, sleep diaries, or reported fatigue. BT was not shown to have an effect on fatigue.

Limitations

  • There was a lack of true baseline values of sleep and fatigue because patients were enrolled after surgery.
  • There was no control of patients’ expectations of treatment.
  • There were modifications to stimulus control and restriction therapy within the BT intervention model.
  • The study population lacked racial/ethnic diversity.

Nursing Implications

BT may be used by trained nurses to improve sleep quality in patients with breast cancer receiving adjuvant chemotherapy. Further research is needed to determine the long-term effects of BT on sleep quality and fatigue in this population.

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