| NCT ID | NCT07219264 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ponce Medical School Foundation, Inc. |
| Condition | Mental Health Care |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,260 participants |
| Start Date | 2025-09-26 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,260 participants in total. It began in 2025-09-26 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
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.
Contact & Investigator
Eida M Castro-Figuera, PsyD, MSc
PRINCIPAL INVESTIGATOR
Ponce Medical School Foundation, Inc.
Frequently Asked Questions
Who can join the NCT07219264 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 99 Years, studying Mental Health Care. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07219264 currently recruiting?
Yes, NCT07219264 is actively recruiting participants. Contact the research team at ecastro@psm.edu for enrollment information.
Where is the NCT07219264 trial being conducted?
This trial is being conducted at Ponce, Puerto Rico.
Who is sponsoring the NCT07219264 clinical trial?
NCT07219264 is sponsored by Ponce Medical School Foundation, Inc.. The principal investigator is Eida M Castro-Figuera, PsyD, MSc at Ponce Medical School Foundation, Inc.. The trial plans to enroll 1,260 participants.