Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Metastatic Colorectal Cancer

Treatments: Behavioral: Qualitative interview; Behavioral: Cognitive Interviews

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05840263

K08CA267313 (U.S. NIH Grant/Contract)

22-2246.cc

Details and patient eligibility

About

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.

Full 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).

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

48 participants in 3 patient groups

Metastatic Colorectal Cancer Patients

Description:

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.

Treatment:

Behavioral: Cognitive Interviews

Behavioral: Qualitative interview

Metastatic Colorectal Cancer Patients Partners

Description:

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.

Treatment:

Behavioral: Cognitive Interviews

Behavioral: Qualitative interview

Clinicians

Description:

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.

Treatment:

Behavioral: Qualitative interview