Mindful PaCT: a couple-based mindfulness program for metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study tests a newly developed couple-based mindfulness program called Mindful PaCT, delivered via video conferencing. It targets both patients with metastatic colorectal cancer and their partners, aiming to reduce distress and improve psychosocial well-being. The study also includes a health and wellness education control condition to provide a comparison. Feasibility, acceptability, and preliminary psychosocial effects will be assessed to inform future larger trials. Eligibility is limited to English-speaking adults with metastatic colorectal cancer and their partners who can participate together for the study duration.

Why it matters

Who can join: the full rules

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 to 85.
* Fluent in English language. All study materials, including the informed consent form, participant workbooks, and questionnaires, are currently available only in English. Participation requires the ability to independently read and engage with written study materials (including the participant workbook), which are integral to the intervention session content and home practices. Therefore, individuals who are unable to read study materials in English are not eligible to participate. At this time, the intervention has not been translated or validated in other languages, therefore participation is limited to individuals who can read, speak, and understand English to ensure that participants are able to fully engage with study activities.
* Be a person (i.e., patient) diagnosed with metastatic colorectal cancer (mCRC) or a partner (e.g., spouse) of someone diagnosed with mCRC.
* Indicates a score \>0 on the Distress Thermometer
* Has access to computer/internet through with video-conferencing (phone, laptop, tablet, desktop computer)

Additional eligibility criteria include:

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. Monogamy is not required for eligibility; however, in cases of polyamorous relationships, the patient will designate a primary partner for participation in the study.

Additional partner participant inclusion criteria:

• Has been in a committed relationship \>6 months with a patient who meets the above eligibility criteria

Eligibility for relationship status will be self-reported by participants during recruitment.

Exclusion Criteria:

* One or both members of the couple has an active or poorly controlled 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.
* The couple is currently in active couples (e.g., marital) therapy together.

Participants who are physically or mentally too ill to participate or those with major cognitive impairments are excluded because they may not be able to engage with intervention sessions, surveys. No exclusions will be made based on sexual orientation, race, gender, or other sociodemographic features. Because patients with mCRC are living longer, and patients and partners can experience distress at various times since their diagnosis, we do not limit participation by time since diagnosis.

Where it's running

• University of Colorado Hospital
  Aurora, Colorado, United States Recruiting

Study contacts

• Principal investigator: Lauren Zimmaro, PhD — University of Colorado, Denver
• Study coordinator: Kaylee Ortega
• Email: kaylee.ortega@cuanschutz.edu
• Phone: 3037248895

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.