Grant Number:	1K08CA267313-01A1 Interpret this number
Primary Investigator:	Zimmaro, Lauren
Organization:	Research Inst Of Fox Chase Can Ctr
Project Title:	Addressing Colorectal Cancer-Related Distress: Developing and Evaluating a Couple-Based Mindfulness Intervention
Fiscal Year:	2022

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.

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