Clinical trial NCT05840263: Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer
Official title: Developing a Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer: Qualitative Phase
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Colorectal Cancer
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-05-03
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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).

Eligibility 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

Primary outcomes:
measure: Identify the needs of mCRC patients for intervention content
timeFrame: During the one-time qualitative interview
measure: Identify the preferences of mCRC patients for intervention content
timeFrame: During the one-time qualitative interview
measure: Identify the needs of mCRC patients' partners for intervention content
timeFrame: During the one-time qualitative interview
measure: Identify the preferences of mCRC patients' partners for intervention content
timeFrame: During the one-time qualitative interview
measure: Identify the preferences of mCRC patients for intervention format (eg, session length)
timeFrame: During the one-time qualitative interview
measure: Identify the preferences of mCRC patients' partners for intervention format (eg, session length)
timeFrame: During the one-time qualitative interview
measure: Identify the preferences of mCRC patients partners for intervention format
timeFrame: During the one-time qualitative interview
measure: Extract key themes to integrate into preliminary drafts
timeFrame: During the one-time qualitative interview
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Lauren Zimmaro
role: PRINCIPAL_INVESTIGATOR
References: