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NCT Number: NCT05840263

Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer

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.

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Identify the needs of mCRC patients for intervention content

    Time frame: During the one-time qualitative interview

    Completed through semi-structured qualitative interviews

  2. Identify the preferences of mCRC patients for intervention content

    Time frame: During the one-time qualitative interview

    Completed through semi-structured qualitative interviews

  3. Identify the needs of mCRC patients' partners for intervention content

    Time frame: During the one-time qualitative interview

    Completed through semi-structured qualitative interviews

  4. Identify the preferences of mCRC patients' partners for intervention content

    Time frame: During the one-time qualitative interview

    Completed through semi-structured qualitative interviews

  5. 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

  6. 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

  7. Identify the preferences of mCRC patients partners for intervention format

    Time frame: During the one-time qualitative interview

    Completed through semi-structured qualitative interviews

  8. 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).

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 3, 2023
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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