Higher fatigue levels are found in women with stage I or II breast cancer receiving adjuvant chemotherapy (CT) who adopt patterns of daytime inactivity and nighttime restlessness and have more symptom and psychological distress. Interventions that improve sleep quality and reduce daytime fatigue in persons with insomnia may also benefit women receiving adjuvant CT. Using selected factors from Piper's Integrated Fatigue Model (IFM), a randomized, controlled clinical trial will compare women with breast cancer who receive a four component behavioral sleep intervention to women in the attentional control group during and after adjuvant CT. The intervention is designed to reduce fatigue in these women by promoting daytime activity, improving sleep quality and decreasing symptom and psychological distress.
The aims of this study are to: 1) Compare the immediate (sleep/wake, activity/exercise, symptoms, psychological distress) and consequent (fatigue) outcomes of a four component behavioral sleep intervention (sleep hygiene counseling, relaxation therapy, sleep restriction, and stimulus control) in an experimental group (n=110) with outcomes in an attentional control group (n=110) in women with stage I or II breast cancer during 4 or 8 cycles of adjuvant CT, at 30, 60, and 90 days after their last treatment, and 1 year after their first baseline; 2) Determine the extent to which factors selected from the IFM influence fatigue intensity levels a) in the total sample and 1 year after the first treatment and 3) Evaluate the adherence to the refined behavioral sleep intervention and preferences for sleep hygiene and relaxation therapy techniques in the experimental group over time. Women will be randomized on the basis of good or poor sleeping history and intent to treat (4 versus 8 cycles of CT) to an experimental or attentional control group. Using the co-scientist model, the experimental group will follow an Individual Sleep Promotion Plan negotiated with the investigator with regularly scheduled reinforcements and revisions. The control group will receive equal time and attention regarding general topics and nutrition. Established instruments include the Piper Fatigue scale, Hospital Anxiety and Depression Scale, SF-36 Health Survey, Symptoms Experience Scale, Daily Diary and Insomnia Severity Index. Objective measures include wrist actigraphs, hemoglobin/hematocrit, white blood count, T4 and TSH, and body mass index. Statistical analyses include RM-ANOVA, generalized estimation equation methodology and multiple regression analysis. Results may inform development of clinical guidelines for fatigue management during adjuvant CT.
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