Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1260 participants
INTERVENTIONAL
2025-09-26
2028-08-31
Brief Summary
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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
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Mental Health CPR Intervention
Participants in this arm will receive the Mental Health PR community-based behavioral intervention. The program consist pf structured sections facilitated by trained Community Mental Health Workers (CHMWs) focused on improving communication, stress management, and access to mental health services. Sessions are delivered in small groups through culturally tailored materials and multimedia tools.
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.
Standard Community Health Education
Participants in this arm receive standard community health education about mental health and wellness, without the structured Mental Health CPR behavioral components. This comparator arm allows for the evaluation of the added benefit of the Mental Health CPR intervention beyond general health education. Due to ethical considerations, the community-led intervention will be offered to the control arm after the community-intervention arm is completed. Participants in this arm will receive standard community health education materials about mental health and wellness, without the Mental Health CPR behavioral training components. This serves as the comparison group to evaluate the effectiveness of the intervention.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
21 Years
99 Years
ALL
Yes
Sponsors
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University of Rochester
OTHER
University of Puerto Rico Medical Sciences Campus
UNKNOWN
Ponce Medical School Foundation, Inc.
INDUSTRY
Responsible Party
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Eida M Castro-Figueroa
Principal Investigator
Principal Investigators
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Eida M Castro-Figuera, PsyD, MSc
Role: PRINCIPAL_INVESTIGATOR
Ponce Medical School Foundation, Inc.
Locations
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Ponce Medical School Foundation, Inc.
Ponce, Puerto Rico, Puerto Rico
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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