University of Colorado Hospital
Aurora, Colorado, 80045, United States
NCT Number: NCT07759921
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.
Trial opening soon.
Get Notified18 year–85 year
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Additional eligibility criteria include:
Additional patient participant inclusion criteria:
Additional partner participant inclusion criteria:
Eligibility for relationship status will be self-reported by participants during recruitment.
Exclusion criteria
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.
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.
Other names: Mindful PaCT
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.
Other names: Wellness PaCT
Time frame: From enrollment through post-intervention assessment at approximately 8 weeks
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 weeks
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 weeks
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: At post-intervention assessment at approximately 8 weeks
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
Contact information is provided by the study sponsor or research team.
University of Colorado, Denver
Other
Feasibility and Acceptability of a Novel Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer: A Pilot Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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