Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer

Sponsor

University of Colorado, Denver (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05840263

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Colorectal Cancer	Behavioral: Qualitative interview Behavioral: Cognitive Interviews

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 Design

Study Type:

Observational

Anticipated Enrollment :

48 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	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.

Arm

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

Behavioral: Cognitive Interviews

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Cancer Center	Aurora	Colorado	United States	80045

Sponsors and Collaborators

University of Colorado, Denver
National Cancer Institute (NCI)

Investigators

Principal Investigator: Lauren Zimmaro, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT05840263

Other Study ID Numbers:

22-2246.cc
K08CA267313

First Posted:

May 3, 2023

Last Update Posted:

May 6, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of May 6, 2023