Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer

February 24, 2026 updated by: University of Colorado, Denver

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Cancer Center
        • Principal Investigator:
          • Lauren Zimmaro, PhD
        • Sub-Investigator:
          • Chris Lieu, MD
        • Sub-Investigator:
          • Jennifer Reese, MD
        • Sub-Investigator:
          • Jamie Studts, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Metastatic Colorectal Cancer Patients

Metastatic Colorectal Cancer Patients' Partners

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.

Description

Patient 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify the needs of mCRC patients for intervention content
Time Frame: During the one-time qualitative interview
Completed through semi-structured qualitative interviews
During the one-time qualitative interview
Identify the preferences of mCRC patients for intervention content
Time Frame: During the one-time qualitative interview
Completed through semi-structured qualitative interviews
During the one-time qualitative interview
Identify the needs of mCRC patients' partners for intervention content
Time Frame: During the one-time qualitative interview
Completed through semi-structured qualitative interviews
During the one-time qualitative interview
Identify the preferences of mCRC patients' partners for intervention content
Time Frame: During the one-time qualitative interview
Completed through semi-structured qualitative interviews
During the one-time qualitative interview
Identify the preferences of mCRC patients for intervention format (eg, session length)
Time Frame: During the one-time qualitative interview
Completed through semi-structured qualitative interviews
During the one-time qualitative interview
Identify the preferences of mCRC patients' partners for intervention format (eg, session length)
Time Frame: During the one-time qualitative interview
Completed through semi-structured qualitative interviews
During the one-time qualitative interview
Identify the preferences of mCRC patients partners for intervention format
Time Frame: During the one-time qualitative interview
Completed through semi-structured qualitative interviews
During the one-time qualitative interview
Extract key themes to integrate into preliminary drafts
Time Frame: 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).
During the one-time qualitative interview

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Lauren Zimmaro, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2023

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 21, 2023

First Submitted That Met QC Criteria

April 21, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-2246.cc
  • K08CA267313 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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