Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Behavioral: Qualitative interviewBehavioral: Cognitive Interviews
- Registration Number
- NCT05840263
- Lead Sponsor
- University of Colorado, Denver
- 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.
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
- 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.)
∙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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Metastatic Colorectal Cancer Patients Partners Cognitive Interviews 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 Qualitative interview 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. Metastatic Colorectal Cancer Patients Qualitative interview 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 Cognitive Interviews 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 Qualitative interview 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.
- Primary Outcome Measures
Name Time Method 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 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
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).
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' partners for intervention format (eg, session length) During the one-time qualitative interview Completed through semi-structured qualitative interviews
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States