Trials Sponsors Conditions Drugs Pricing

Conditions

Colorectal Cancer Metastatic Colorectal Cancer (CRC)

Keywords

CouplePartnerCaregiver

Outcome Measures

Primary Outcomes (3)

Feasibility of Intervention through Study Accrual
Feasibility will be measured through study accrual, retention/attrition, and session completion rates, based on similar couple-based behavioral interventions in advanced cancer. Accrual feasibility will be indicated by: Recruitment and accrual efficiency, defined as enrolling \>50% of eligible approached couples (i.e., 45 couples after approaching fewer than 90 couples).
From enrollment through post-intervention assessment at approximately 8 weeks
Feasibility of Intervention through Intervention Retention Rates
Feasibility will be measured through study accrual, retention/attrition, and session completion rates, based on similar couple-based behavioral interventions in advanced cancer. Retention feasibility will be indicated by: Intervention retention rate of \> 70% Mindful PaCT couples (i.e., complete assessments at both pre-and post-intervention timepoints).
From enrollment through post-intervention assessment at approximately 8 weeks
Feasibility of Intervention through Intervention Completion Rates
Feasibility will be measured through study accrual, retention/attrition, and session completion rates, based on similar couple-based behavioral interventions in advanced cancer. Session completion feasibility will be indicated by: Intervention completion rate, defined by attendance of all 4 Mindful PaCT sessions, in \> 50% of couples.

Secondary Outcomes (1)

Participant Satisfaction Score of the PaCT Program
At post-intervention assessment at approximately 8 weeks

Study Arms (2)

Mindful PaCT

EXPERIMENTAL

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.

Behavioral: Couple-based Mindfulness Intervention

Wellness PACT

PLACEBO COMPARATOR

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.

Behavioral: Health and Wellness Education Control Condition

Interventions

Couple-based Mindfulness InterventionBehavioral

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.

Also known as: Mindful PaCT

Mindful PaCT

Health and Wellness Education Control Condition

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

National Cancer Institute (NCI)
NIHcollaborator
University of Colorado, Denver
Otherlead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

Kaylee OrtegaCONTACT303-724-8895 kaylee.ortega@cuanschutz.edu

Lauren Zimmaro, PhDPRINCIPAL INVESTIGATOR

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Health

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

Lauren Zimmaro, PhD
University of Colorado, Denver
PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaylee Ortega

CONTACT

3037248895 kaylee.ortega@cuanschutz.edu

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 22, 2026

First Posted

August 12, 2026

Study Start

December 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

December 2030

Novel Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (1)

Study Arms (2)

Mindful PaCT

Wellness PACT

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (1)

Study Arms (2)

Mindful PaCT

Wellness PACT

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations