Recruiting

Mindful PaCT

Sponsor:

University of Colorado, Denver

Code:

NCT07759921

Conditions

Colorectal Cancer

Metastatic Colorectal Cancer (CRC)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Couple-based Mindfulness Intervention

Health and Wellness Education Control Condition

Study Details

Brief summary:

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.

Conditions

Colorectal Cancer

Metastatic Colorectal Cancer (CRC)

Study ID

NCT07759921

Start date

Dec, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Mindful PaCT

Patient-partner dyads assigned to this arm receive Mindful PaCT, a couple-based mindfulness program delivered through four weekly, 60- to 75-minute sessions via secure videoconferencing. Sessions are facilitated by a trained interventionist. Couples also receive a program workbook and access to supplemental audio and video mindfulness practices for use between sessions.

placebo comparator: Wellness PACT

Patient-partner dyads assigned to this arm receive Wellness PaCT, a couple-based educational program delivered through four weekly, 60- to 75-minute sessions via secure videoconferencing. Sessions are facilitated by a trained interventionist and address general wellness, sleep and fatigue, diet and nutrition, and exercise and physical activity. Couples also receive a program workbook and supplemental educational resources for use between sessions.

Interventions

Couple-based Mindfulness Intervention

Mindful PaCT is a manualized, couple-based mindfulness intervention designed to reduce distress and strengthen coping among patients with metastatic colorectal cancer and their partners. The intervention includes four weekly, 60- to 75-minute sessions delivered to each patient-partner dyad via secure videoconferencing by a trained interventionist. Sessions address four core mindfulness competencies: awareness, acceptance, compassion, and connection. Intervention content includes mindfulness-based education, guided experiential exercises, and skill-building activities designed to support individual and relational coping and adjustment in the context of advanced cancer. Couples receive a workbook containing session materials and access to supplemental audio and video recordings of guided mindfulness practices to support between-session practice and continued skill development.

Health and Wellness Education Control Condition

Wellness PaCT is a manualized, couple-based educational intervention designed as an active, attention-matched control condition for patients with metastatic colorectal cancer and their partners. The intervention includes four weekly, 60- to 75-minute sessions delivered to each patient-partner dyad via secure videoconferencing by a trained interventionist. Each session focuses on a wellness topic relevant to coping with metastatic colorectal cancer: general wellness, sleep and fatigue, diet and nutrition, and exercise and physical activity. Intervention content includes health education and structured activities intended to support healthy lifestyle behaviors in the context of advanced cancer. Couples receive a workbook containing session materials and access to supplemental educational resources to support continued learning between sessions.

Primary outcome measure

  • Feasibility of Intervention through Study Accrual [ Time Frame: From enrollment through post-intervention assessment at approximately 8 weeks ]
  • Feasibility of Intervention through Intervention Retention Rates [ Time Frame: From enrollment through post-intervention assessment at approximately 8 weeks ]
  • Feasibility of Intervention through Intervention Completion Rates [ Time Frame: From enrollment through post-intervention assessment at approximately 8 weeks ]

Central Contacts and Locations

Central contacts

Kaylee Ortega

3037248895kaylee.ortega@cuanschutz.edu

Locations

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Kaylee Ortega

303-724-8895kaylee.ortega@cuanschutz.edu

Principal Investigator:

Lauren Zimmaro, PhD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • Couple
  • Partner
  • Caregiver

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-08-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.