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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/摘要转移性结直肠癌 (mCRC) 的诊断及其治疗会改变高达 60% 的 mCRC 患者的生活；相似比例的亲密伴侣报告了临床上显着的痛苦程度。1-5 mCRC 通常会在个人和人际关系层面带来独特的挑战，6-14 和干预措施迫切需要旨在解决这些问题并减少面临 mCRC 的夫妇的痛苦。6-8,10-12,28,30 鉴于减少癌症痛苦的有力证据，基于正念的干预（MBI）可以填补这一空白患者32-34和伴侣35以及改善关系结果。36-38然而，现有的MBI不太适合鉴于其内容和格式的一些不足之处，针对面临 mCRC 的夫妇。需要修改现有的 MBI，这是一个新的基于夫妇的 MBI，旨在满足独特的需求因此，拟议研究项目的总体目标是开发，完善并评估为期四次、以夫妻为基础的正念干预（“MIND-Together”：正念共同应对困境）通过视频会议进行，旨在促进正念应对和首先，我们将生成有关需求和偏好的数据。 12 对面临转移性结直肠癌的夫妇（N = 24 名患者和伴侣）以及 12 对通过定性治疗转移性结直肠癌的夫妇访谈，其中包括有关干预内容（例如范围）和结构（例如格式）的询问。我们将制定干预方案草案，该草案将通过认知访谈进行完善和最终确定与 6 名 mCRC 夫妇（N = 12 名患者和伴侣）和专家评审其次，我们将评估可行性，通过在 45 名参与者中进行的试点随机对照试验，了解干预措施的可接受性和初步效果 mCRC 夫妇（N=90 名患者和伴侣），按 2:1 分配给 MIND-Together（n=30 夫妇）或注意力控制条件（n = 15对夫妇）在探索性目标中，我们将使用退出访谈来探索。夫妻的 MIND-Together 体验，以进一步优化干预内容和实施方式，以及确定在未来试验中评估的潜在机制。研究完成后，我们将确定是否存在。该干预措施是可行的、可接受的，并且在减少夫妇样本的痛苦方面初步有效未来的研究将是在更大范围内评估干预效果并评估中介因素。除了研究之外，三个内容领域的正式培训也将支持 PI 的目标。成为一名独立研究者，具有开发、评估和交付方面的专业知识对癌症患者的干预措施包括：(1) 癌症生存问题。结直肠癌患者，(2) 以夫妇为基础的改善癌症心理社会结果的方法幸存者，以及（3）制定和评估心理社会干预措施。总体而言，拟议的研究具有以下特点。可能有助于解决面临 mCRC 的夫妇的关键社会心理需求，并推进科学癌症护理中的正念和基于夫妻的方法。