Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer

Metastatic Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05840263
• Other study ID #: 22-2246.cc
• Secondary ID: K08CA267313
• Status: Recruiting
• Start date: May 31, 2023
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: University of Colorado, Denver
• Contact: Joshua Pasek
• Phone: 3037242419
• Email: joshua.pasek[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Colorado Cancer Center	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify the needs of mCRC patients for intervention content	Completed through semi-structured qualitative interviews	During the one-time qualitative interview
Primary	Identify the preferences of mCRC patients for intervention content	Completed through semi-structured qualitative interviews	During the one-time qualitative interview
Primary	Identify the needs of mCRC patients' partners for intervention content	Completed through semi-structured qualitative interviews	During the one-time qualitative interview
Primary	Identify the preferences of mCRC patients' partners for intervention content	Completed through semi-structured qualitative interviews	During the one-time qualitative interview
Primary	Identify the preferences of mCRC patients for intervention format (eg, session length)	Completed through semi-structured qualitative interviews	During the one-time qualitative interview
Primary	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
Primary	Identify the preferences of mCRC patients partners for intervention format	Completed through semi-structured qualitative interviews	During the one-time qualitative interview
Primary	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