Addressing Colorectal Cancer-Related Distress: Developing and Evaluating a Couple-Based Mindfulness Intervention

解决结直肠癌相关的困扰：制定和评估基于夫妻的正念干预措施

• 批准号: 10683394
• 负责人: Lauren A. Zimmaro
• 金额: $ 16.45万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-12 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10683394
• 关键词: Address; Affect; Area; Attention; Awareness; Behavioral; Belief; Body Image; Cancer Patient; Cancer Survivor; Cancer Survivorship; Chronic; Clinical; Colorectal Cancer; Communication; Compassion; Continuance of life; Couples; Data; Development; Diagnosis; Distress; Education; Educational process of instructing; Emotions; Evaluation; Excision; Fatigue; Fecal Incontinence; Feces; Future; Goals; Individual; Intervention; Interview; Intestines; Length; Life; Light; Love; Malignant Neoplasms; Measures; Mediator; Nature; Operative Surgical Procedures; Ostomy; Outcome; Participant; Patients; Perception; Persons; Protocols documentation; Quality of life; Randomized; Randomized, Controlled Trials; Reporting; Research; Research Personnel; Research Project Grants; Sampling; Science; Sexuality; Shame; Structure; Surveys; Time; Training; Treatment Efficacy; active method; cancer care; care giving burden; clinical care; clinically significant; cognitive interview; colon cancer patients; coping; design; effective intervention; emotional distress; end of life; evidence base; expectation; experience; gastrointestinal symptom; improved; innovation; intervention delivery; intervention effect; intervention refinement; intimate behavior; member; metastatic colorectal; mindfulness; mindfulness intervention; physical symptom; pilot trial; post intervention; preference; primary outcome; psychologic; psychosocial; randomized trial; research study; side effect; skills; skills training; therapy design; tool; trend; videoconference

PROJECT SUMMARY/ABSTRACT A diagnosis of metastatic colorectal cancer (mCRC) and its treatment is life-altering; up to 60% of mCRC patients and a similar percentage of their intimate partners report clinically significant levels of distress.1-5 Effects of mCRC often lead to unique challenges on both an individual and relationship level,6-14 and an intervention designed to address these concerns and reduce distress in couples facing mCRC is critically needed.6-8,10-12,28,30 A mindfulness-based intervention (MBI) could fill this gap, given strong evidence for reducing distress in cancer patients32-34 and partners35 and in improving relationship outcomes.36-38 However, existing MBIs are poorly suited for couples facing mCRC due to several inadequacies in their content and format. Given significant changes that would be needed to modify an existing MBI, a new couple-based MBI designed to meet the unique needs of mCRC couples is warranted. Therefore, the overall objective of the proposed research project is to develop, refine, and evaluate a four-session, couple-based mindfulness intervention (“MIND-Together”: Mindfully Navigating Distress Together) delivered via video-conference and designed to promote mindful coping and reduce distress for mCRC patients and their partners. First, we will generate data on the needs and preferences of 12 couples facing mCRC (N=24 patients and partners) and 12 clinicians treating mCRC through qualitative interviews, which will include queries about intervention content (e.g., scope) and structure (e.g., format). Then we will develop drafts of the intervention protocol, which will be refined and finalized through cognitive interviews with 6 mCRC couples (N=12 patients and partners) and expert review. Second, we will assess the feasibility, acceptability, and preliminary effects of the intervention through a pilot randomized controlled trial among 45 mCRC couples (N=90 patients and partners), assigned 2:1 to either MIND-Together (n=30 couples) or an attention-controlled condition (n=15 couples). In an exploratory aim, we will use exit interviews to explore couples’ experiences of MIND-Together in order to further optimize the intervention content and delivery, and identify potential mechanisms to assess in future trials. Upon study completion, we will have established whether the intervention is feasible, acceptable, and preliminarily efficacious in reducing distress in a sample of couples facing mCRC. Future research will be to evaluate the intervention efficacy and assess mediators in a larger randomized trial. In addition to the research study, formal training in three content areas will support the PI’s goal of becoming an independent investigator with expertise in the development, evaluation, and delivery of interventions among individuals affected by cancer. Training areas include: (1) cancer survivorship issues among colorectal cancer patients, (2) couple-based approaches for improving psychosocial outcomes in cancer survivors, and (3) developing and evaluating psychosocial interventions. Overall, the proposed research has the potential to help address the critical psychosocial needs of couples facing mCRC and to advance the science of mindfulness and couple-based approaches in cancer care.

项目摘要/摘要 转移性结直肠癌的诊断和治疗改变了生活；高达60%的转移性结直肠癌患者 而他们的亲密伴侣中有类似比例的人报告了临床上显著的痛苦水平。 MCRC经常在个人和关系层面上带来独特的挑战，6-14岁和干预 6-8、10-12、28、30 基于正念的干预(MBI)可以填补这一空白，因为有强有力的证据表明，这种干预可以减少癌症患者的痛苦 患者32-34和伴侣35以及改善关系的结果。36-38然而，现有的mbi不太适合 对于因其内容和格式上的一些不足而面临mcrc的夫妇。鉴于重大变化， 将需要修改现有的MBI，这是一种新的基于夫妇的MBI，旨在满足 Mcrc夫妇是有保障的。因此，拟议研究项目的总体目标是开发、 改进和评估为期四个疗程的、基于夫妻的正念干预(“一起思考”：正念 共同导航痛苦)通过视频会议传递，旨在促进正念应对和 减少多发性结直肠癌患者及其伴侣的痛苦。首先，我们将生成有关需求和偏好的数据 在12对面临mCRC的夫妇(N=24名患者和伴侣)和12名临床医生中，通过定性 访谈，其中将包括关于干预内容(例如，范围)和结构(例如，格式)的询问。然后 我们将制定干预方案草案，并通过认知面谈加以完善和最终确定 包括6对结直肠癌夫妇(N=12名患者和伴侣)和专家回顾。第二，我们将评估可行性， 在45名受试者中进行的先导性随机对照试验的可接受性和干预的初步效果 MCRC夫妇(N=90名患者和伴侣)，2：1分配给心连心(n=30对夫妇)或 注意控制状态(n=15对夫妇)。在探索性目标中，我们将使用离职访谈来探索 夫妻心灵相聚的体验，以进一步优化干预内容和交付，以及 确定潜在的机制以在未来的试验中进行评估。在研究完成后，我们会确定是否 该干预是可行的、可接受的，并且在减少夫妇样本中的痛苦方面初步有效。 面对mcrc。未来的研究将在更大范围内评估干预效果和评估介体 随机试验。除研究性研究外，三个内容领域的正式培训将支持PI的目标 成为一名独立的调查员，在开发、评估和交付方面具有专业知识 对受癌症影响的个人进行干预。培训领域包括：(1)癌症生存问题 结直肠癌患者，(2)改善癌症患者心理社会结局的夫妇方法 幸存者，以及(3)发展和评估心理社会干预。总体而言，拟议的研究具有 有可能帮助解决面临mcrc的夫妇的关键心理社会需求，并推动 癌症护理中的正念和基于夫妇的方法。