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Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer

NCT05840263 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2026-02-25

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Qualitative 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.

BEHAVIORAL

Cognitive 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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Lauren Zimmaro · University of Colorado, Denver

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2026-04-30
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05840263 on ClinicalTrials.gov