Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer

Trial Title: Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer

NCT ID: NCT05840263

Condition: Metastatic Colorectal Cancer

Conditions: Official terms:
Colorectal Neoplasms

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Behavioral
Intervention name: Qualitative interview
Description: 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 group label: Clinicians
Arm group label: Metastatic Colorectal Cancer Patients
Arm group label: Metastatic Colorectal Cancer Patients Partners

Intervention type: Behavioral
Intervention name: Cognitive Interviews
Description: 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.
Arm group label: Metastatic Colorectal Cancer Patients
Arm group label: Metastatic Colorectal Cancer Patients Partners

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.

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).

Criteria for eligibility:

Study pop:
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.

Sampling method: Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 85 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: University of Colorado Cancer Center

Address:
City: Aurora
Zip: 80045
Country: United States

Status: Recruiting

Investigator:
Last name: Lauren Zimmaro, PhD
Email: Principal Investigator

Investigator:
Last name: Chris Lieu, MD
Email: Sub-Investigator

Investigator:
Last name: Jennifer Reese, MD
Email: Sub-Investigator

Investigator:
Last name: Jamie Studts, PhD
Email: Sub-Investigator

Start date: May 31, 2023

Completion date: December 2025

Lead sponsor:
Agency: University of Colorado, Denver
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: University of Colorado, Denver

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05840263