NCT07219264

Mental Health CPR for Cancer Survivors

Mental Health CPR: Transforming Cancer Survivors' Mental Health With Community Participatory Reach

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,260 (estimated)
• Sponsor: Ponce Medical School Foundation, Inc. · Industry
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Accepted

Summary

This is a parallel, two-arm interventional study comparing the Mental Health CPR behavioral intervention to standard community health education. The goal of this clinical trial is to learn if Mental Health CPR program, a culturally and linguistically adapted behavioral intervention, helps improve emotional well-being and access to mental health services among Hispanic/Latino cancer survivors in Puerto Rico. The main questions it aims to answer are: * Does Mental Health CPR help more people complete psychological distress screening? * Does it help more participants connect with psycho-oncology services? Researchers will compare the Mental Health CPR program to standard community health education to determine whether it improves emotional well-being, enhances communication between patients and caregivers, reduces negative attitudes toward mental health care, and lowers emotional distress levels. Participants will: * Attend community sessions led by trained Community Mental Health Workers (CMHWs) * Receive printed materials and educational resources * Take part in brief follow-ups over about 36 weeks

Detailed description

Mental Health CPR is a community-based behavioral intervention designed to improve access to psycho-oncology care and promote psychological well-being among Hispanic/Latino cancer survivors in Puerto Rico. The program was developed through a community-engaged process to ensure cultural and linguistic appropriateness and sustainability. The study employs a cluster randomized parallel design in which community clusters are assigned to one of two conditions: the Mental Health CPR intervention or a standard community health education program. Trained Community Mental Health Workers (CMHWs) implement both arms concurrently over a 36-week period. The Mental Health CPR intervention includes: * Multimedia community sessions addressing emotional health and coping after cancer; * Printed educational materials on distress screening and mental health resources; and * Follow-up to reinforce key messages and promote connection to psycho-oncology services. The comparison attention control group will be invited to attend general health fairs in which mental health printed educational materials will be available along with distress screening assessment. Primary outcomes include completion of distress screening and uptake of psycho-oncology services. Secondary outcomes assess emotional distress, patient-caregiver communication, attitudes toward mental health care, quality of life, resilience, and selected salivary biomarkers related to stress and inflammation. The study's findings will inform future strategies to enhance access to psycho-oncology services, strengthen the capacity of community-based health workers, and promote mental health care among cancer survivors living in under-supported communities.

Conditions

• Mental Health Care
• Mental Health
• Depression Anxiety Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Mental Health CPR	The Mental Health CPR is a culturally adapted behavioral intervention implemented by trained Community Mental Health Workers (CMHWs). It includes interactive sessions designed to improve emotional well-being, communication between cancer survivors and caregivers, and access to mental health services. The content integrates educational videos, group discussions, and digital resources from the Community Mental Health Toolbox. The intervention also reinforces sustainability by promoting local resource use and peer support networks. Additionally, the intervention will periodically conduct mental health and distress screenings, integrate mental health promotion educational activities and skill-building activities, case management component will integrate the cancer-mental health toolbox and linkage to Psycho-Oncology Mental Health Services (MHCS) component through the PAPSI psycho-oncology mental health service program at PHSU if needed.
BEHAVIORAL	Standard Community Health Education	The control group receives standard behavioral health education materials commonly distributed in community health settings. These materials include information on stress reduction, healthy lifestyle habits, and general mental health awareness but do not include interactive or CMHW-facilitated sessions.

Timeline

• Start date: 2025-09-26
• Primary completion: 2028-07-31
• Completion: 2028-08-31
• First posted: 2025-10-21
• Last updated: 2025-10-21

Locations

1 site across 1 country: Puerto Rico