Management of Insomnia in Cancer Patients

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DESCRIPTION (provided by applicant): Overview and Public Health Relevance: Oxana Palesh, Ph.D., a clinical psychologist, is applying for a career development award to expand her research skills and become an independent investigator in cancer control. Her long-term research objective is to reduce insomnia and insomnia symptoms in cancer patients and cancer survivors, groups with a high prevalence of these problems. In fact, sleep problems were reported by 70% of 330 breast cancer patients in a recent study by Dr. Palesh. Dr. Palesh's Career Development Plan builds upon a strong research background obtained at Stanford and the U of Rochester by enhancing specific measurable knowledge and skills in four areas: 1) cancer treatment and control, 2) the conduct of multi-center trials, 3) insomnia assessment and treatment, and 4) transitioning to an independent research career. Her primary mentor, Gary Morrow, Ph.D., has been a leader in cancer control for 30 years. He will contribute expertise in cancer and side effect management and in clinical trial design and analysis. Dr. Palesh's co-mentors also have outstanding experience in training researchers. Joseph Roscoe, Ph.D., will contribute expertise in behavioral research and cancer. Thomas Roth, Ph.D., an internationally recognized expert, will provide in-depth training in sleep research and treatment of insomnia. They are assisted by an Advisory Board of experts in cancer treatment, insomnia research, psychopharmacology and biostatistics. Research Plan: The proposed RCT, based on well established theoretical principles, expands promising preliminary data showing that both pharmacologic and behavioral interventions can improve insomnia. The two approaches will be compared with standard care in a 4 arm (Drug: yes/no; Behavioral Treatment: yes/no) randomized clinical trial of 60 breast cancer patients receiving chemotherapy. The primary goal is to provide preliminary data and effect size estimates for an R01 application to confirm results. These results will clarify the role of insomnia in the experiences of cancer patients undergoing treatment, inform potential strategies for interventions in these patients, and position Dr. Palesh, in combination with the training provided by this award, to successfully transition to a career as an independent investigator and leader in cancer control science.