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

项目总结/摘要 转移性结直肠癌（mCRC）的诊断及其治疗是改变生活的;高达60%的mCRC患者 和相似比例的亲密伴侣报告临床显著的痛苦水平。 mCRC通常会在个人和关系层面（6-14）以及干预措施方面带来独特挑战 旨在解决这些问题并减少面临mCRC的夫妇的痛苦，这是迫切需要的。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可以减少癌症患者的痛苦 患者32 -34和合作伙伴35以及改善关系结果。36 -38然而，现有的MBIs不适合 由于其内容和形式存在一些不足之处，面临mCRC的夫妇。鉴于重大变化， 将需要修改现有的MBI，一个新的夫妇为基础的MBI，旨在满足独特的需求， mCRC夫妇是必要的。因此，拟议研究项目的总体目标是开发， 完善，并评估四个会议，夫妇为基础的正念干预（“一起念”：正念 通过视频会议提供，旨在促进谨慎应对， 减轻mCRC患者及其伴侣的痛苦。首先，我们将生成关于需求和偏好的数据， 12对面临mCRC的夫妇（N=24例患者和伴侣）和12名通过定性研究治疗mCRC的临床医生 访谈，其中将包括关于干预内容的询问（例如，范围）和结构（例如，格式）。然后 我们将制定干预协议草案，并通过认知访谈进行完善和定稿 6对mCRC夫妇（N=12例患者和伴侣）和专家评审。第二，我们会评估可行性， 可接受性和干预的初步效果，通过一个试点随机对照试验，45 mCRC夫妇（N=90例患者和伴侣），按2：1分配至MIND-Together（n=30对夫妇）或 注意力控制条件（n=15对夫妇）。为了探索性的目的，我们将使用离职面谈来探索 夫妇的MIND-Together体验，以进一步优化干预内容和交付， 确定在未来试验中评估的潜在机制。研究完成后，我们将确定 干预是可行的，可接受的，并初步有效地减少样本夫妇的痛苦 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质 随机试验除了研究性学习，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） 结直肠癌患者，（2）改善癌症患者心理社会结局的基于夫妇的方法 幸存者;（3）制定和评估心理社会干预措施。总的来说，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，并促进 正念和基于夫妇的方法在癌症护理。

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.