Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05840263
Status
Recruiting
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Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Qualitative interview — BEHAVIORAL
    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.
  • Cognitive Interviews — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 31, 2023
Status verified
Feb 2026
Primary completion
Apr 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
48 participants (estimated)

Arms

  • Arm: Metastatic Colorectal Cancer Patients
    We anticipate enrolling up to a total of 18 patients who have been diagnosed with metastatic colorectal cancer; 12 patients will participate in the qualitative interview, and 6 patients will participate in the cognitive interview.
  • Arm: Metastatic Colorectal Cancer Patients Partners
    We anticipate enrolling up to a total of 18 partners of patients who have been diagnosed with metastatic colorectal cancer; 12 partners will participate in the qualitative interview, and 6 paartners will participate in the cognitive interview.
  • Arm: Clinicians
    We anticipate enrolling 12 clinicians (including physicians, nurse practitioners, physician assistants, mental health providers, other advanced practice clinicians) who treat patients with colorectal cancer at the University of Colorado to participate in qualitative interviews. We seek to enroll a variety of clinicians from advanced practiced clinical roles (physicians, nurse practitioners, and mental health providers) to capture diverse perspectives.

Primary Outcome Measure

Identify the needs of mCRC patients for intervention content [ Time Frame: During the one-time qualitative interview ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Cancer CenterAuroraColorado80045
Lauren Zimmaro, PhD (PRINCIPAL_INVESTIGATOR)
Chris Lieu, MD (SUB_INVESTIGATOR)
Jennifer Reese, MD (SUB_INVESTIGATOR)
Jamie Studts, PhD (SUB_INVESTIGATOR)

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By research site
University of Colorado Cancer Center· Aurora, CO

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