Novel Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Couple-based Mindfulness Intervention
BehavioralMindful 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
BehavioralWellness 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Mindful PaCTExperimental treatment 1 intervention
Group B: Wellness PACTPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
From enrollment through post-intervention assessment at approximately 8 weeks2
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).
Time frame
From enrollment through post-intervention assessment at approximately 8 weeks3
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.
Time frame
From enrollment through post-intervention assessment at approximately 8 weeksSecondary outcomes
1
Participant Satisfaction Score of the PaCT Program
To evaluate acceptability of the Mindful PaCT program, all participants will be asked to complete an 8-item client satisfaction questionnaire to gauge how satisfied they are with the quality of the program and identify areas for improvement. a. Client Satisfaction Questionnaire-8 item (CSQ-8) mean score \> 28
Time frame
At post-intervention assessment at approximately 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov