Grant Number:	1R21CA102066-01 Interpret this number
Primary Investigator:	Riggs, Raine
Organization:	Dartmouth College
Project Title:	Cbt for Chronic Insomnia in Breast Cancer Survivors
Fiscal Year:	2003

DESCRIPTION (provided by applicant): The primary goal of the proposed study is to determine the efficacy and patient acceptability of a manualized cognitive behavioral treatment for chronic insomnia (CBTCI) in early stage breast cancer survivors with chronic insomnia. Sleep complaints are common among cancer survivors. In particular, chronic insomnia is almost twice as prevalent among breast cancer survivors as it is among the general population. Chronic insomnia may result in fatigue, cognitive impairments, mood disturbance, increased pain, and immunosuppression, all of which negatively affect a woman's quality of life and may play a role in the recurrence of cancer. While a highly efficacious, safe intervention exists for the treatment of chronic insomnia, it has not yet been applied to cancer survivors. In the proposed study, 60 early stage breast cancer survivors, matched on potentially important prognostic factors such as age, menopausal status, and time elapsed since initial treatment, will be recruited from the Breast Oncology Center at the Dana Farber Cancer Institute. The women will be randomized to one of two groups. One group of breast cancer survivors will receive eight, individual, weekly CBTCI sessions and the other group will receive eight, individual, weekly cognitive behavioral placebo sessions (CBP). All participants will provide self-report data on their sleep, fatigue, depressive symptoms, and pain levels throughout the study. Participants will also complete patient satisfaction questionnaires at the conclusion of treatment to assess treatment acceptability and credibility. It is hypothesized that the women in the CBTCI group will experience statistically and clinically significantly improvements in self-reported sleep and sleep quality, while the women in the CBP group will remain stable. It is also hypothesized that increased sleep quality will be related to decreased levels of depressive symptoms, fatigue, and pain.





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