Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer

Recruiting

• Conditions: Metastatic Colorectal Cancer

• Registration Number: NCT05840263
• Lead Sponsor: University of Colorado, Denver

Brief Summary

The overall objective of this study is to develop a novel couple-based mindfulness intervention aimed at reducing distress in patients with metastatic colorectal cancer (mCRC) and their partners.

Detailed Description

The overall objective of this study is to develop a novel couple-based mindfulness intervention aimed at reducing distress in patients with metastatic colorectal cancer (mCRC) and their partners. The intervention is named "MIND-Together" (Mindfully Navigating Distress Together). MIND-Together will be the first mindfulness-based intervention designed to reduce mCRC couples' distress by targeting their unique psychosocial needs. The intervention is projected to be a 4-session intervention delivered by a trained therapist to individual couples facing mCRC (i.e., a patient and his/her intimate partner) via video-conference (e.g., Zoom).

Study Timeline

• Study First Submitted: 2023-04-21
• Study First Submitted QC: 2023-04-21
• Study First Posted: 2023-05-03
• Study Start: 2023-05-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-13
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Provision to sign and date the consent form.
• Stated willingness to comply with all study procedures and be available for the duration of the study.
• Be aged > 18 years.
• Fluent in English language
• Be a person (i.e., patient) diagnosed with metastatic colorectal cancer (mCRC), a partner (e.g., spouse) of someone diagnosed with mCRC, or a clinician who treats patients diagnosed with mCRC.

Additional patient participant inclusion criteria:

• Has a current diagnosis of metastatic (Stage IV, recurrent) colorectal cancer
• Has an ECOG status <2 or otherwise deemed appropriate for study participation by a clinician
• Is in a committed relationship with a romantic partner for >6 months
• Has access to computer/internet through with video-conferencing (phone, laptop, tablet, desktop computer)
• Indicates a score >0 on the Distress Thermometer

Additional partner participant inclusion criteria:

• Has been in a committed relationship >6 months with a patient who meets the above eligibility criteria
• Has access to computer/internet through with video-conferencing (phone, laptop, tablet, desktop computer)
• Indicates a score >0 on the Distress Thermometer

Additional clinician participant inclusion criteria:

∙Is a physician or advanced practice clinician (e.g., oncologist, nurse practitioner, physician assistant, psychologist, mental health provider, etc.)

Exclusion Criteria

∙Has a serious mental illness (e.g., psychotic disorder), cognitive impairment (e.g., dementia), or medical condition (e.g., significant impaired sight/hearing) that would compromise participation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify the preferences of mCRC patients' partners for intervention content	During the one-time qualitative interview	Completed through semi-structured qualitative interviews
Identify the preferences of mCRC patients for intervention format (eg, session length)	During the one-time qualitative interview	Completed through semi-structured qualitative interviews
Identify the preferences of mCRC patients partners for intervention format	During the one-time qualitative interview	Completed through semi-structured qualitative interviews
Identify the preferences of mCRC patients for intervention content	During the one-time qualitative interview	Completed through semi-structured qualitative interviews
Identify the needs of mCRC patients' partners for intervention content	During the one-time qualitative interview	Completed through semi-structured qualitative interviews
Extract key themes to integrate into preliminary drafts	During the one-time qualitative interview	analyze these qualitative data to extract key themes and will integrate the findings with preliminary drafts of the MIND-Together protocol (e.g., participant handouts, therapist manual).
Identify the needs of mCRC patients for intervention content	During the one-time qualitative interview	Completed through semi-structured qualitative interviews
Identify the preferences of mCRC patients' partners for intervention format (eg, session length)	During the one-time qualitative interview	Completed through semi-structured qualitative interviews

Trial Locations

Locations (1)

University of Colorado Cancer Center; 🇺🇸 Aurora, Colorado, United States