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.

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.

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.

• 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.

• Multi-site
• Twelve oncology clinics

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

• 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

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).

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.

• 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.