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.

To determine the effectiveness of a behavioral therapy (BT) intervention, an individualized sleep promotion plan (ISPP), on sleep quality and fatigue in women with breast cancer receiving adjuvant chemotherapy.

Participants were recruited and screened for eligibility between 2003 and 2006. Eligible women interested in participation were visited by a research nurse who completed the randomization procedure, administered baseline questionnaires, and had patients wear an actigraph two days prior to the initial treatment. The intervention was delivered by research nurses who were trained by a sleep psychologist.

Those assigned to the BT group developed a 120-item ISPP with the research nurse according to the nurse's review of responses to measures to identify areas of sleep difficulty. Advice and information was tailored to individual needs. Revisions to the ISPP were made in 30-minute appointments made with participants two days prior to each treatment and 30 days after the last treatment. Reinforcement of the plan was made in 15-minute appointments seven days after each revision. Each ISPP included

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

Patients in the control group received equal time and attention at each home visit and were provided with general support and a discussion of a new healthy eating topic.

• 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 study group, 14% of patients had cancer stage above II, at IIIA.
• Of the patients, 75% had at least some college education.
• The majority of the patients were employed outside the home.
• Patients were excluded if they had a self-reported comorbidity associated with poor sleep and fatigue.

Multisite

This was a randomized, controlled study.

• Symptom Experience Scale (SES) to measure the distress experiences of nausea, pain, appetite, bowel pattern, concentration, and appearance
• Hospital Anxiety and Depression Scale (HADS)
• Medical Outcomes Study Short Form General Health Survey, version 2 (MOS-SF-36-v2)
• Piper Fatigue Scale (PFS):  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

Baseline sleep quality measures indicated mild fatigue, somewhat poor sleep quality, low levels of symptom distress, and normal anxiety and depression levels. PSQI scores indicated lower sleep quality than the general adult population but better scores than those previously associated with poor sleep quality in patients with breast cancer. There were significant differences over time on all sleep variables from the diaries and actigraphs (p < 0.01). Diaries showed a significantly lower number of awakenings (p = 0.032), a lower average amount of time awake while in bed (p = 0.027), and higher sleep efficiency (p = 0.001) in the BT group.  Fatigue scores in both groups increased during treatment and decreased after treatment ended (p < 0.0001). This pattern was similar in both study groups. Perceived fatigue was similar between the two groups. There was a trend of improved sleep quality over time (PSQI) in the BT group.

The four-component ISPP was associated with improved sleep quality over time, better sleep efficiency, and fewer awakenings. Findings suggested that perceptions of improved sleep quality were not consistently associated with diary entries or objective sleep measures.

• Study participants tended to have relatively good sleep quality and low fatigue prior to chemotherapy compared to other reported patients with breast cancer. This may have reduced the effects seen and makes the clinical impact of findings unclear.
• The study ended 30 days after the last treatment; therefore, the longer-term effectiveness cannot be determined.
• The intervention was provided by trained nurses rather than sleep specialists, which may have affected the findings.
• The relative effectiveness of nurse-delivered BT has not been examined.