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Brief Title: Cognitive-Behavioral Intervention for Worry, Uncertainty, and Insomnia for Cancer Survivors
Official Title: Worry, Uncertainty and Insomnia: A Cognitive-behavioral Intervention for Cancer Survivors
Study ID: NCT01929720
Brief Summary: This randomized clinical trial studies a cognitive-behavioral intervention to treat worry, uncertainty, and insomnia in cancer survivors. Counseling may reduce anxiety and insomnia as well as improve the well-being and quality of life of cancer survivors. This study also explores the neuro-immunologic correlates of anxiety and insomnia.
Detailed Description: PRIMARY OBJECTIVES: I. To complete a randomized pilot trial of a cognitive-behavioral anxiety-insomnia intervention to determine the impact of this intervention on patient worry, intolerance of uncertainty, and sleep efficiency. II. Explore the underlying endocrine and immune mechanisms responsible for a specific symptom cluster (anxiety-insomnia-depression-pain-fatigue) observed among advanced cancer patients. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients wear a wrist actigraph, collect saliva samples, and complete a sleep diary and worry record daily in weeks 1 and 5. Patients also receive education on the components of anxiety (physical cognitive, and behavioral) and practice relaxation techniques and behavioral sleep strategies in weeks 2-5. Blood draw is optional. ARM II: Patients wear a wrist actigraph, collect saliva samples, and complete a sleep diary and worry record daily in weeks 1 and 5. Blood draw is also optional. This is a wait-list control arm, so patients in this arm, after a six-week period of treatment as usual with their oncologist, then receive the intervention.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Wexner Medical Center at The Ohio State University Department of Psychiatry, Columbus, Ohio, United States
Name: Sharla Wells-Di Gregorio, Ph.D.
Affiliation: Ohio State University Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR