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Novel Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer

Novel Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer

Recruiting
18-85 years
All
Phase N/A

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Overview

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.

Description

Metastatic colorectal cancer (mCRC) causes significant distress in patients and partners. Mindfulness-based interventions (MBIs) can reduce distress but existing MBIs have limitations for mCRC couples. An MBI tailored to mCRC couples' needs and delivered via video-conferencing could remedy such limitations and reduce distress in this population. This new intervention, called Mindful PaCT, has been preliminarily developed and now needs to be assessed for feasibility, acceptability, and preliminary psychosocial effects.

Eligibility

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.

Study details
    Colorectal Cancer
    Metastatic Colorectal Cancer (CRC)

NCT07759921

University of Colorado, Denver

15 August 2026

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