About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Participants residing outside the catchment area.
Trial design
Parallel
Treatments tested in this trial
Mental Health CPR
BehavioralThe 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
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Development of the Community Toolbox for the Mental Health CPR Intervention
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.
Distress Thermometer (DT)
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)
Psych-oncology mental health service referral uptake
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.
Secondary outcomes
Communication and Caregiving Assessment Tool (Patient Form - CCAT-PF)
The Communication and Caregiving Assessment Tool - Patient Form (CCAT-PF) is a validated self-report scale that assesses the quality and effectiveness of communication between patients and their primary caregivers. The scale includes items rated on a Likert-type format to evaluate understanding, emotional support, and problem-solving aspects of the patient-caregiver relationship. Higher scores indicate better communication quality. Mean score on the CCAT-PF (range 1-5)
Communication and Caregiving Assessment Tool (Caregiver Form - CCAT-CF)
The Communication and Caregiving Assessment Tool - Patient Form (CCAT-PF) is a validated self-report instrument that measures the patient's perception of communication quality with their primary caregiver. Items are rated on a Likert-type scale assessing emotional support, understanding, and collaborative problem solving. Higher scores indicate better communication quality. Mean CCAT-PF total score (range 1-5)
Self-Stigma of Mental Illness Scale (SSMIS)
The Self-Stigma of Mental Illness Scale (SSMIS), developed by Corrigan et al. (2006), is a validated 40-item self-report instrument that measures internalized stigma toward mental illness and help-seeking. The SSMIS assesses four sequential components of self-stigma: awareness of stereotypes, agreement with stereotypes, application of stereotypes to oneself, and harm to self-esteem. Items are rated on a 9-point Likert scale (1 = strongly disagree to 9 = strongly agree). Higher scores indicate greater self-stigma. Mean SSMIS total score (range 1-9)
Psychological distress, assessed with the Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS), is a validated 14-item self-report questionnaire designed to assess symptoms of anxiety and depression in medical and community populations. It consists of two subscales-HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D)-each containing 7 items scored from 0 to 3. Subscale scores range from 0 to 21, with higher scores indicating greater anxiety or depression symptom severity. Mean HADS-A and HADS-D subscale scores (range 0-21)
Sponsors and contacts
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Ponce Medical School Foundation, Inc.
Lead sponsor
University of Rochester
Collaborator
University of Puerto Rico Medical Sciences Campus
Collaborator