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NCT07759921Recruiting

Novel Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer

Feasibility and Acceptability of a Novel Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer: A Pilot Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 14 Aug 2026

Brief summary (registry, in English)

The overall objective of this study is to learn whether a newly developed couple-based mindfulness program (Mindful PaCT) is practical to complete (feasible), helpful and well-received (acceptable), and relevant for patients with metastatic colorectal cancer (mCRC) and their partners.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
90 (estimated)
First submitted
22 Jul 2026
Start date
Dec 2026
Primary completion date
Dec 2030
Lead sponsor
University of Colorado, Denver
NCT number
NCT07759921

What you commit to

  • Study type: Interventional
  • Planned participants: 90
  • From Dec 2026 to the primary completion date, Dec 2030
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University of Colorado Hospital
Coordinator of this site? Confirm its status
AuroraUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.