Mental Health CPR: Transforming Cancer Survivors' Mental Health With Community Participatory Reach
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,260
- Locations
- 1
- Primary Endpoint
- Development of the Community Toolbox for the Mental Health CPR Intervention
Study Overview
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
Although participants and intervention facilitators are aware of group assignment due to the behavioral nature of the intervention, masking is applied to the outcomes assessment process. Laboratory personnel responsible for the processing and analysis of saliva samples for biological markers are blinded to group assignment to maintain objectivity in outcome measurement.
Eligibility Criteria
- Ages
- 21 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion 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
- •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.
Arms & Interventions
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.
Intervention: Mental Health CPR (Behavioral)
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.
Intervention: Standard Community Health Education (Behavioral)
Outcomes
Primary Outcomes
Development of the Community Toolbox for the Mental Health CPR Intervention
Time Frame: 18 months
This outcome reflects the successful design, adaptation, and completion of the Community Toolbox - a culturally and linguistically tailored set of multimedia and printed resources developed to support the implementation of the Mental Health CPR intervention by Community Mental Health Workers (CMHWs). The Toolbox integrates educational modules, testimonial videos, infographics, and text message templates addressing distress screening, stigma reduction, communication enhancement, and linkage to psycho-oncology services. Completion is defined as finalization of all Toolbox modules validated through expert and community stakeholder review under Specific Aim 1.
Psych-oncology mental health service referral uptake
Time Frame: 9 months
The percentage of participants who, after being screened for psychological distress, accept and complete at least one referral to psycho-oncology or behavioral health services. Uptake will be defined as documented attendance at one or more sessions with a licensed mental health or psycho-oncology provider. Data will be collected through Community Mental Health Worker (CMHW) tracking logs and verified by participant follow-up. Higher percentages indicate greater engagement in mental health services following the intervention.
Distress Thermometer (DT)
Time Frame: 9 months
The Distress Thermometer (DT) is a validated single-item visual analog screening tool developed by the National Comprehensive Cancer Network (NCCN) to measure psychological distress in cancer patients. Participants rate their distress over the past week on a scale from 0 (no distress) to 10 (extreme distress). Higher scores indicate greater emotional distress. Mean DT score (0-10 scale)
Secondary Outcomes
- Communication and Caregiving Assessment Tool (Patient Form - CCAT-PF)(9 months)
- Salivary Stress Hormone Levels (Cortisol and Alpha-Amylase)(9 months)
- Communication and Caregiving Assessment Tool (Caregiver Form - CCAT-CF)(9months)
- Self-Stigma of Mental Illness Scale (SSMIS)(9 months)
- Psychological distress, assessed with the Hospital Anxiety and Depression Scale (HADS)(9 months)
- Health-Related Quality of Life assessed with the Functional Assessment of Cancer Therapy - General (FACT-G, Version 4)(9 months)
- Perceived Social Support, asses with Multidimensional Scale of Perceived Social Support (MSPSS)(9 months)
- Brief Resilience Scale (BRS)(9 months)
- Salivary Cytokine and Chemokine Concentrations(9 months)
Investigators
Eida M Castro-Figueroa
Principal Investigator
Ponce Medical School Foundation, Inc.