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

简短行为疗法治疗癌症相关失眠在减轻头痛负担方面的功效：探索患者表型和反应预测因子

• 批准号: 10302033
• 负责人: Oxana G Palesh
• 金额: $ 20.21万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-03-01 至 2021-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10302033
• 关键词: Address; Age; American Society of Clinical Oncology; Area; Attention; Behavior Therapy; Behavioral; Behavioral trial; Biological; Breast Cancer survivor; Cancer Patient; Cancer Survivor; Chronic; Circadian Rhythms; Clinical; Clinical Trials; Competence; Conditioned Insomnia; Data; Development; Development Plans; Diagnosis; Eagles; Education; Equipoise; Faculty; Gender; Geriatric Psychiatry; Goals; Grant; Headache; Headache Disorders; Healthy Eating; Hydrocortisone; Intervention; Intracranial Neoplasms; Knowledge; Learning; Malignant Neoplasms; Manuscripts; Measures; Mediating; Mediator of activation protein; Medical; Medical Oncology; Medicine; Mental Depression; Mentors; Mentorship; Migraine Variants; Mission; Modeling; Multi-Institutional Clinical Trial; Multicenter Trials; Outcome; Pain; Parents; Participant; Patients; Phenotype; Physiological; Placebo Control; Population; Positioning Attribute; Publications; Quality of life; Race; Reporting; Research; Research Personnel; Research Project Summaries; Risk Factors; Secure; Sleep; Sleep disturbances; Sleeplessness; Statistical Data Interpretation; Survival Rate; Survivors; Symptoms; Testing; Time; Training; Translational Research; Treatment-Related Cancer; Universities; Writing; actigraphy; anticancer research; arm; associated symptom; base; behavioral clinical trial; biobehavior; cancer survival; cancer therapy; cancer type; career; career development; chemotherapy; circadian; cohort; comorbidity; compliance behavior; data handling; data reduction; design; disability; disabling symptom; efficacy evaluation; efficacy testing; experience; health disparity; improved; innovation; instructor; intervention effect; longitudinal analysis; parent grant; precision medicine; predicting response; preservation; primary outcome; professor; psychologic; racial disparity; response; secondary outcome; side effect; skills; symposium; targeted treatment; therapy development; translational research program

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.

研究：虽然许多癌症幸存者抱怨致残性头痛， 缺乏对无颅内肿瘤的癌症幸存者的头痛研究。癌症幸存者会得到新的- 新发头痛、偏头痛变体或其进展，或治疗引起的继发性头痛- 相关副作用？控制癌症相关的失眠能减轻头痛负担吗？这种补充剂 将研究睡眠行为干预对缓解头痛的效果，这可能会减少失眠 症状，改善生活质量。我们的初步结果表明，癌症的短期行为疗法 相关抑制剂（BBT-CI）可能有效减少乳腺癌幸存者的头痛负担。使用 在母基金中收集的数据，目标1检查BBT-CI组的患者是否会显著降低 每月头痛天数（主要结局）、睡眠、抑郁和皮质醇水平（次要结局）， 健康饮食教育学习健康睡眠（HEAL）。对于目标2，参与者将被分类 临床上有意义的队列和头痛表型。对于目标3，我们将测试 副交感神经功能、皮质醇、体动记录仪中度BBT-CI疗效，以检查反应预测因子。通过 由于使用针对两种情况（失眠和头痛）的单一行为疗法， 数据驱动的患者表型，这一建议是创新的，符合新兴的精准医疗。 培训：该多样性补充将为Yohannes Woldeamanuel博士提供指导培训， 帮助他成为一名独立的调查员，解决与诊断相关的症状， 癌症的治疗（例如，头痛）在癌症幸存者（即NCI）等患病人群中- 相关研究领域。他的培训将侧重于以下核心能力：（a）行为临床试验 在癌症研究中，（B）纵向和临床试验数据分析的统计能力，（c）职业生涯 开发活动（例如，R 01赠款写作，第一作者出版物，创建目标导向的计划 翻译研究）。为了实现这些目标，Woldeamanuel博士组建了一个导师团队， 行为临床试验（Palesh博士，主要导师），统计分析（Jo博士，共同导师），以及 睡眠医学、头痛医学、健康差异、老年心理学和医学肿瘤学（Kushida博士， 分别为科万、戈尔-费尔顿、卡西迪-伊格尔、冯）。该补充将提供培训和保护 Woldeamanuel博士撰写独立赠款的时间（例如，R21/R 01）用于开发和有效性试验 癌症幸存者头痛的个性化行为干预，建立一个研究利基， 助理教授级别的教职员职位。补充将帮助他开始建立一个 精准医学转化研究计划，减轻癌症幸存者的头痛负担。