A Behavioral Integrative Intervention for Reducing Cancer-related Fatigue

减少癌症相关疲劳的行为综合干预

• 批准号: 9268738
• 负责人: Stephanie Jean Sohl
• 金额: $ 12.47万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-01 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9268738
• 关键词: Address; Adherence; Adult; Affect; Attention; Behavior Therapy; Behavioral; Breast Cancer survivor; Breathing; Cancer Intervention; Cancer Patient; Cancer Survivor; Circadian Rhythms; Clinical; Clinical Oncology Supplement (K12); Colorectal Cancer; Conduct Clinical Trials; Control Groups; Data; Development; Development Plans; Diagnosis; Educational Intervention; Educational process of instructing; Empathy; Environment; Evaluation; Fatigue; Funding; Goals; Grant; Health; Home environment; Individual; Inflammation; Informal Social Control; Intervention; Interview; Investigation; Learning; Malignant Neoplasms; Measurement; Measures; Mediator of activation protein; Medical; Meditation; Mental Depression; Mentored Research Scientist Development Award; Mentors; Methodology; Methods; Modeling; Movement; Outcome; Participant; Patient Care; Patients; Pattern; Physical activity; Principal Investigator; Psychological Stress; Publications; Quality of life; Randomized; Randomized Controlled Trials; Reporting; Research; Research Personnel; Research Support; Research Training; Structure; Symptoms; Techniques; Technology; Therapeutic; Training; Training Activity; Treatment Efficacy; United States National Institutes of Health; Woman; Work; Writing; Yoga; active control; behavioral study; biobehavior; cancer care; cancer type; career; career development; chemotherapy; clinical care; colon cancer patients; common symptom; depressive symptoms; diaries; exercise intervention; exhaustion; experience; follow-up; implementation research; improved; meetings; men; novel; oncology; patient subsets; primary outcome; programs; psychologic; public health relevance; secondary outcome; skills; skills training; standard measure; symptom cluster; therapy design; trend

 DESCRIPTION (provided by applicant): This Mentored Research Scientist Development Award (K01) will facilitate the candidate's long-term career goal to be an independent investigator who will advance the research on the health impact of complementary behavioral interventions that are integrated into standard medical care of cancer patients (i.e., behavioral integrative interventions). Behavioral integrative interventions provide patients with skills they can use to reduce cancer-related symptoms during their daily lives. The candidate proposes to conduct clinical trials to evaluate such interventions and learn new methodology that captures how these interventions affect patients on a daily basis in their home environments and enables optimization of these interventions. The planned research focuses on investigating the impact of a behavioral integrative intervention (i.e., Yoga Skills Training; YST) that is implemented individually during chemotherapy on fatigue and depressive symptoms in patients diagnosed with colorectal cancer (CRC). CRC is the third most prevalent cancer in both men and women, fatigue is one of the most common and severe symptoms reported in CRC patients, and there are increasing numbers of CRC survivors. Fatigue frequently co-occurs with depressive symptoms, which are also common in CRC patients and may share underlying biobehavioral mechanisms (i.e., psychological stress, circadian disruption and inflammation). Fatigue and depressive symptoms follow a pattern such that they peak 3-5 days after chemotherapy and then improve, although not to baseline levels in a substantial subset of patients. In addition, symptoms experienced during treatment are related to subsequent symptoms. Despite this high symptom burden, there are few behavioral interventions designed for CRC patients to proactively improve fatigue and depressive symptoms during chemotherapy. Yoga, an intervention that combines psychological components (i.e., breathing practices, meditation) and gentle physical activity may be an optimal approach to reducing fatigue and depressive symptoms. Yoga has shown promise for improving fatigue, depressive symptoms, and biobehavioral mediators (i.e., psychological stress, circadian disruption and inflammation). Although research supports the efficacy of yoga when investigated in the group-class format primarily with breast cancer survivors, participants with high symptom burden and other cancer types are less likely to participate. Yoga has not yet been studied when implemented individually during chemotherapy to be more inclusive of patients with higher symptom burden or exclusively in patients with CRC. The planned study will build upon the candidate's previous research by piloting an improved randomized study of 60 patients undergoing chemotherapy for CRC with more robust measurements (i.e., daily assessment of symptoms, objective measure of circadian disruption, qualitative follow-up evaluation) and enhancement of the YST (i.e., more targeted to fatigue, attention to treatment fidelity, focused on adherence to home practice). This study aims to determine preliminary efficacy for the primary outcome of fatigue, secondary outcome of depressive symptoms, and possible mediators (i.e., psychological stress, circadian disruption, inflammation) as assessed by standard measures (Aim 1); to measure the impact of the YST versus the AC on daily assessments of fatigue, depressive symptoms, and proposed mediators in the same trial and explore relationships among daily and standard assessments (Aim 2); and to qualitatively assess perceived efficacy of the YST and AC and acceptability of new daily assessment methodology through semi-structured interviews in a subset of 20-40 participants (Aim 3). Through the mentored implementation of this research and complementary training activities, the candidate also aims to achieve the following short-term training goals: (1 to utilize technology to evaluate ecologically valid daily assessments of fatigue, depressive symptoms, circadian disruption and adherence to home practice and (2) methods (i.e., qualitative, yoga therapy techniques) to enhance the efficacy of behavioral integrative interventions. The candidate's complementary training activities are detailed in a career development plan that integrates this mentored research experience with the structured completion of coursework, attendance at seminars and meetings, publication of research, and gaining further experience in grant writing. Further, the candidate is currently in an especially strong environment that she is optimally utilizing to develop a novel program of behavioral integrative research. In summary, the proposed research is novel because it shifts the traditional paradigm from yoga taught to a group outside of the clinical setting to the individual during clinical care, which may reach patients with higher symptom burden. Further this study will utilize daily assessments of symptoms and adherence to home practice to understand the efficacy of the interventions when symptoms are at their worst. In addition, the daily fluctuation of symptoms experienced during chemotherapy is an ideal model for evaluating how self-regulation skills taught by the YST may improve patients' daily quality of life. Accomplishment of the proposed short-term training objectives will augment the candidate's career as an independent investigator who is uniquely qualified to advance the rigor of the study of behavioral integrative interventions for cancer patients.

 描述（由适用提供）：这项受过指导的研究科学家发展奖（K01）将促进候选人的长期职业目标，成为一个独立的研究者，他们将提高对互补行为干预措施对健康影响的研究，这些干预措施融入了癌症患者的标准医疗（即行为综合干预措施）。行为综​​合干预措施为患者提供了减少日常生活中与癌症相关症状的技能。候选提案进行临床试验以评估这种干预措施并学习新方法，以捕获这些干预措施在家庭环境中如何影响患者，并可以优化这些干预措施。计划研究的重点是研究行为综合干预（即瑜伽技能培训； YST）的影响，该干预措施在化学疗法期间对诊断为结直肠癌（CRC）患者的疲劳和抑郁症状进行了单独实施。 CRC是男性和女性中第三大流行的癌症，疲劳是CRC患者报告的最常见和严重症状之一，CRC存活率越来越多。疲劳经常与抑郁症状同时发生，在CRC患者中也很常见，并且可能具有潜在的生物行为机制（即心理压力，昼夜节律破坏和炎症）。疲劳和抑郁症状遵循一种模式，使得它们在化疗后3-5天达到峰值，然后改善，尽管在大量患者中不能达到基线水平。此外，治疗期间经历的症状与随后的症状有关。尽管伯恩（Burnen）症状很高，但为CRC患者设计的行为干预措施很少，可以主动改善化学疗法期间的疲劳和抑郁症状。瑜伽，一种结合心理成分（即呼吸练习，冥想）和轻柔体育锻炼的干预措施可能是减轻疲劳和抑郁症状的最佳方法。瑜伽表现出有望改善疲劳，抑郁症状和生物行为介质（即心理压力，昼夜节律破坏和注射）的希望。尽管研究以乳腺癌幸存者为基础的小组级格式进行研究，但症状高伯恩氏症和其他癌症类型的参与者不太可能参与瑜伽的效率。在化学疗法期间单独实施的瑜伽尚未被研究，以使伯恩症状较高的患者或CRC患者完全包括在内。计划的研究将基于候选人的先前研究，通过对60名接受化学疗法进行CRC的患者进行了改进的随机研究（即对症状的日常评估，昼夜节律中断的客观评估，定性后续评估）的客观测量，对YST的增强（即，对主动性的效率更高效率，更具针对性的练习）。这项研究旨在确定疲劳的主要结果，抑郁症状的次要结果以及可能的介体（即心理压力，昼夜节律破坏，炎症）的初步效率（AIM 1）；在同一试验中，衡量YST与AC对疲劳，抑郁症状和拟议的调解人的日常评估的影响，并探索日常和标准评估之间的关系（AIM 2）；并通过半结构化访谈在20-40个参与者的子集中进行定性评估YST和AC的感知效率以及新的日常评估方法的可接受性（AIM 3）。通过这项研究和补充培训活动的实施，候选人还旨在实现以下短期培训目标：（1利用技术评估对疲劳，抑郁症状，昼夜症状的破坏和对家庭练习的生态有效的日常评估，以及（即2）的方法（即，YOGA疗法的效率），以促进Yoga治疗的效率。在职业发展计划中详细介绍了这项重要的研究经验与课程的结构化完成，下水道和会议的出席，研究的出版物以及授予写作方面的进一步经验，候选人目前处于一个特别强大的环境中，她最佳地利用了拟议的临床研究，因为它在概述的范围内开发了一个新颖的研究。在临床护理期间，该人可能会吸引伯恩症状较高的患者。此外，这项研究将利用症状和遵守家庭练习的日常评估，以了解症状最坏的干预措施的效率。此外，化学疗法期间经历的症状的每日波动是评估YST教授的自我调节技能如何改善患者日常生活质量的理想模型。实现拟议的短期培训目标将扩大候选人作为独立调查员的职业，他们具有独特的资格，可以促进癌症患者行为综合干预措施的严格研究。