Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Behavioral: Qualitative interview
* Behavioral: Cognitive Interviews


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Metastatic Colorectal Cancer Patients<br>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<br>* 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.<br>Behavioral: Cognitive Interviews<br>* 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.<br>|
| Metastatic Colorectal Cancer Patients Partners<br>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<br>* 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.<br>Behavioral: Cognitive Interviews<br>* 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.<br>|
| Clinicians<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |