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.

项目综述-研究：尽管许多癌症幸存者抱怨头痛致残，但有 在没有颅内肿瘤的癌症幸存者中，头痛的研究很少。癌症幸存者会得到一个新的- 新发头痛，偏头痛的变种或进展，或治疗后的继发性头痛- 相关的副作用？控制癌症引起的失眠能减轻头痛负担吗？本副刊 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 症状和改善生活质量。我们的初步结果表明，癌症的短期行为疗法 相关性失眠(BBT-CI)可能是减轻乳腺癌幸存者头痛负担的有效方法。vbl.使用 在父母资助中收集的数据，AIM 1检查了接受BBT-CI ARM的患者是否会有显著的减少 每月头痛天数(主要结果)、睡眠、抑郁和皮质醇水平(次要结果)比 那些参加健康饮食教育的人，学习健康睡眠(Hear)。对于目标2，参与者将被分类 使用数据约简转换为具有临床意义的队列和头痛表型。对于目标3，我们将测试是否 副交感神经功能、皮质醇、肌动描记检查BBT-CI疗效中等以检查反应预测因素。通过 针对两种情况(失眠和头痛)使用单一行为疗法的优点 数据驱动的患者表型，这一建议是创新的，并与新兴的精准医学相一致。 培训：这份多样性补充资料将为Yohannes Woldeamanuel博士提供指导培训，以 帮助他成为一名独立的调查员，解决与诊断和 在患有癌症的人群中治疗癌症(例如头痛)，例如癌症幸存者，即NCI- 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 在癌症研究方面，(B)纵向和临床试验数据分析的统计能力，(C)职业生涯 发展活动(例如，R01赠款撰写、首创出版物、创建目标导向的方案 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，联合导师)，以及 睡眠医学、头痛医学、健康差距、老年心理学和内科肿瘤学(Kushida博士， 考恩、戈尔-费尔顿、卡西迪-鹰、冯)。本副刊将提供培训和保护 Woldeamanuel博士为开发和疗效测试撰写独立赠款(例如，R21/R01)的时间到了 对癌症幸存者的头痛进行个性化行为干预，建立一个研究利基和安全 助理教授级别的教员职位。这份副刊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。