Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer
Developing a Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer: Qualitative Phase
2 other identifiers
observational
48
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2023
CompletedFirst Posted
Study publicly available on registry
May 3, 2023
CompletedStudy Start
First participant enrolled
May 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedFebruary 25, 2026
February 1, 2026
2.8 years
April 21, 2023
February 24, 2026
Conditions
Outcome Measures
Primary Outcomes (8)
Identify the needs of mCRC patients for intervention content
Completed through semi-structured qualitative interviews
During the one-time qualitative interview
Identify the preferences of mCRC patients for intervention content
Completed through semi-structured qualitative interviews
During the one-time qualitative interview
Identify the needs of mCRC patients' partners for intervention content
Completed through semi-structured qualitative interviews
During the one-time qualitative interview
Identify the preferences of mCRC patients' partners for intervention content
Completed through semi-structured qualitative interviews
During the one-time qualitative interview
Identify the preferences of mCRC patients for intervention format (eg, session length)
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)
Completed through semi-structured qualitative interviews
During the one-time qualitative interview
Identify the preferences of mCRC patients partners for intervention format
Completed through semi-structured qualitative interviews
During the one-time qualitative interview
Extract key themes to integrate into preliminary drafts
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
Study Arms (3)
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.
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.
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.
Interventions
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.
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
- 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
- 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
- ∙Is a physician or advanced practice clinician (e.g., oncologist, nurse practitioner, physician assistant, psychologist, mental health provider, etc.)
You may not qualify if:
- ∙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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lauren Zimmaro
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2023
First Posted
May 3, 2023
Study Start
May 31, 2023
Primary Completion
April 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
February 25, 2026
Record last verified: 2026-02