Cancer Control Research5R21CA091869-02
Epstein, Dana R.
INSOMNIA INTERVENTION FOR BREAST CANCER SURVIVORS
DESCRIPTION (provided by applicant): Insomnia is the most common sleep disorder in both the general population and persons with cancer. Many of the sleep characteristics and ineffective insomnia management strategies of patients with cancer are similar to those of persons with insomnia in the general population. Although women with breast cancer appear to have about twice the risk of developing clinically significant levels of insomnia, sleep difficulty has received minimal treatment attention other than pharmacological intervention (e.g. sedatives/hypnotics, antidepressants). There is a paucity of intervention studies addressing the feasibility and efficacy of non-pharmacological treatment for patients most at need and at risk such as breast cancer survivors (BCS). latrogenic, psychological, and developmental factors may contribute to the development of insomnia in BCS and must be considered in the construction and testing of cognitive-behavioral treatment (CBT). The purpose of the study is to pilot test the feasibility (attendance, attrition, adherence to treatment, participant evaluation of treatment) of a multicomponent CBT and the efficacy of CBT for reducing insomnia in BCS. A 2 (group) X 2 (measurement phase) factorial design will be used. Sixty-four breast cancer survivors will be blocked on their type of insomnia (primary or secondary) and randomly assigned within each type of insomnia to one of the two conditions: CBT group or a contact control group. After the screening process, subjects will be assessed at pre-treatment, treatment, and post-treatment. Sleep outcomes will be evaluated using objective (wrist actigraphy) and subjective (daily sleep diaries) measures. In addition, the impact of CBT on the sleep-associated variables of fatigue, mood, and quality of life will also be explored. Descriptive statistics, analyses of covariance, mediational analysis, and regression analysis will be used to examine the data. This feasibility pilot study will provide the basis for a larger study to evaluate efficacy and to examine the effect of the intervention on the quality of survival time and comorbidities among BCS.