Recruiting

Mental Health CPR for Cancer Survivors

ClinicalTrials.gov IDNCT07219264

PhaseNA

Enrollment1260

SponsorPonce Medical School Foundation, Inc.

Age21 Years

SexALL

I'm interested View official listing

Conditions studied

Mental Health Care, Mental Health, Depression Anxiety Disorder

About this study

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

Interventions

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.

Primary outcomes

Development of the Community Toolbox for the Mental Health CPR Intervention (18 months)
Distress Thermometer (DT) (9 months)
Psych-oncology mental health service referral uptake (9 months)

Eligibility information

The study will include adults of all ages representing individuals across all the adulthood stage. The minimum age requirement is 21, which is the legal age of majority in Puerto Rico. Inclusion Criteria: * Eligibility Criteria for Sub-Aim 1a. The eligibility criteria for the qualitative interviews will be 1: Participants over 21 years old, 2: through their role or status, represent any of the following community sectors: cancer care community organization representatives, clinical care providers of cancer patients and survivors, and cancer health educators; 3: self-identified as a Latino/Hispanic; 4: be able to complete an interview. * Eligibility Criteria for Aim 2. Community Forums stakeholders eligibility criteria. The community stakeholders inclusion criteria for the community forum are 1: Participants over 21 years old, 2: through their role or status, represent any of the following community sectors: cancer patients/survivors, cancer patients/survivors identified family caregiver, healthcare providers, cancer supportive care organizations, and advocacy groups, 3: self-identified as a Latino/Hispanic, 4: be able to attend the community forums. * Community Leaders Eligibility Criteria for CMHW training. The inclusion criteria for the community leaders to be trained as CMHW are 1: Participants over 21 years of age, 2: living in a limited resource community in southern Puerto Rico, 3: self-identified as a Latino/Hispanic, and 4: be able to provide support to H-CAPS through their role as CMHW. * Communities Eligibility Criteria. Community municipalities included from the southern health region of Puerto Rico are: Ponce, Arroyo, Coamo, Yauco, Salinas, Guanica, Guayanilla, Juana Diaz, Adjuntas, Guayama, Patillas, Santa Isabel, Penuelas and Villalba. These municipalities were chosen because they represent the catchment area of Ponce Health Sciences University. Also, they are comprised of mostly rural areas (south-central region of Puerto Rico) and present a higher incidence of cancer (south region) and cancer mortality (south-central region) compared to other Puerto Rican Health regions. * Intervention eligibility criteria. The eligibility criteria for the community intervention are 1: Participants over 21 years old, 2: living in any of the municipalities of the southern health region of Puerto Rico and within a limited resource community according to the CDC SVI, 3: self-identified as a Latino/Hispanic, and 4: have had a cancer diagnosis during their adulthood. Exclusion Criteria: * Participants residing outside the catchment area.

Study locations

Ponce Medical School Foundation, Inc., Ponce, Puerto Rico 00732 Puerto Rico

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.