RecruitingNCT05840263

Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer

Developing a Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer: Qualitative Phase


Sponsor

University of Colorado, Denver

Enrollment

48 participants

Start Date

May 31, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests a mindfulness-based program designed for couples where one partner has been diagnosed with metastatic colorectal cancer (cancer of the colon or rectum that has spread). The program teaches both the patient and their partner strategies to cope with stress, anxiety, and the emotional challenges of advanced cancer together. **You may be eligible if...** - You are 18 or older and fluent in English - You are either a patient with metastatic colorectal cancer, the partner or spouse of someone with this diagnosis, or a clinician who treats these patients - Patients must be within 3 years of their metastatic diagnosis and have a committed partner willing to participate **You may NOT be eligible if...** - You are not connected to a metastatic colorectal cancer diagnosis (as patient, partner, or clinician) - You do not speak English fluently - As a patient, you do not have a willing partner who can participate alongside you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALQualitative interview

Qualitative interviews will cover four main goals including: (1) key sources of distress in mCRC patients and partners; (2) perceptions of mindfulness, including benefits, definitions, and applications; (3) barriers and facilitators of participation (e.g. home-based and couple-based skills practice, enrollment); and (4) session format preferences, such as session length and frequency.

BEHAVIORALCognitive Interviews

The objective of the cognitive interviews (60 minutes, led by the PI) is to ensure the comprehensibility and appropriateness of the drafted participant materials. Published guidelines note a sample size of 12 participants (6 mCRC couples) should be sufficient. Participants will be asked to read, review, and mark up the participant materials in order to identify sections that were difficult to understand. They will also be asked to test playing segments of the audio/video recordings to ensure ease of use. A semi-structured interview format will be used to elicit feedback, including a standard verbal survey assessing ease of reading the material, any difficulties experienced, and suggestions they have for improving the ease of material use. Information generated will be used to update materials as necessary.


Locations(1)

University of Colorado Cancer Center

Aurora, Colorado, United States

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NCT05840263


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