Efficacy of Brief Behavioral Therapy for Cancer-Related Insomnia in Reducing Headache Burden: Exploring Patient Phenotypes and Predictors of Response

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Project Summary - Research: Although many cancer survivors complain of disabling headache, there is scarcity of headache research in cancer survivors without intracranial tumors. Do cancer survivors get a new- onset headache de novo, a migraine variant or its progression, or secondary headache from treatment- associated side effects? Does controlling cancer-related insomnia reduce headache burden? This supplement will examine the efficacy of sleep behavioral interventions for headache relief, which may reduce insomnia symptoms and improve quality of life. Our preliminary results show that Brief Behavioral Therapy for Cancer Related Insomnia (BBT-CI) might be efficacious in reducing headache burden in breast cancer survivors. Using data collected in the parent grant, Aim 1 examines if patients on BBT-CI arm will have significant reduction in monthly headache days (primary outcome), sleep, depression, and cortisol levels (secondary outcomes) than those in Healthy EAting Education Learning for healthy sleep (HEAL). For Aim 2, participants will be classified into clinically meaningful cohorts and headache phenotypes using data reduction. For Aim 3, we will test if parasympathetic function, cortisol, actigraphy moderate BBT-CI efficacy to examine response predictors. By virtue of using a single behavioral therapy targeting two conditions (insomnia and headache) and by utilizing data-driven patient phenotyping, this proposal is innovative and consistent with emerging precision medicine. Training: This Diversity Supplement will provide Dr. Yohannes Woldeamanuel with mentored training to help him become an independent investigator addressing symptoms associated with diagnosis and treatment of cancer (e.g., headache) in medically ill populations such as cancer survivors i.e. an NCI- relevant research area. His training will focus on the following core competencies: (a) behavioral clinical trials in cancer research, (b) statistical competency in analyses of longitudinal and clinical trial data, (c) career development activities (e.g. R01 grant writing, first-authored publications, creating goal-directed programmatic translational research). To achieve these goals, Dr. Woldeamanuel has assembled a team of mentors in behavioral clinical trials (Dr. Palesh, primary mentor), statistical analysis (Dr. Jo, co-mentor), and advisors in sleep medicine, headache medicine, health disparities, geriatric psychology and medical oncology (Drs. Kushida, Cowan, Gore-Felton, Cassidy-Eagle, Fung, respectively). This supplement will provide the training and protected time for Dr. Woldeamanuel to write an independent grant (e.g., R21/R01) for development and efficacy testing of personalized behavioral interventions for headache in cancer survivors, establish a research niche and secure a faculty position at an Assistant Professor rank. The supplement will help him to begin establishing a translational research program in precision medicine alleviating headache burden among cancer survivors.