Mental Health CPR for Cancer Survivors

NCT07219264 | Recruiting DMC

• 1 other identifier: U01CA290613
• Study Type: interventional
• Target: 1,260
• Locations: 1 country
• Sites: 1

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

Conditions

Mental Health Care; Mental Health; Depression Anxiety Disorder

Keywords

Mental Health; Distress; Depression; Anxiety

Outcome Measures

Primary Outcomes (3)

• 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.

  18 months

• 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)

  9 months

• 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.

  9 months

Secondary Outcomes (9)

• Communication and Caregiving Assessment Tool (Patient Form - CCAT-PF)

  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

Study Arms (2)

Mental Health CPR Intervention

EXPERIMENTAL

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.

Behavioral: Mental Health CPR

Standard Community Health Education

ACTIVE COMPARATOR

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.

Behavioral: Standard Community Health Education

Interventions

Mental Health CPR BEHAVIORAL

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.

Mental Health CPR Intervention

Standard Community Health Education BEHAVIORAL

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.

Standard Community Health Education

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Participants residing outside the catchment area.

Sponsors & Collaborators

• Ponce Medical School Foundation, Inc.: lead
• University of Rochester: collaborator
• University of Puerto Rico Medical Sciences Campus: collaborator

Study Sites (1)

Ponce Medical School Foundation, Inc.

Ponce, Puerto Rico, 00732, Puerto Rico

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Behavioral Symptoms; Mental Disorders

Study Officials

• Eida M Castro-Figuera, PsyD, MSc

  Ponce Medical School Foundation, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eida M Castro-Figueroa, PsyD, MSc

CONTACT

787-840-2575; ecastro@psm.edu

Guillermo N Armaiz-Pena, PhD

CONTACT

787-840-2575; garmaiz@psm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2025
• First Posted: October 21, 2025
• Study Start: September 26, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: All data gathered by this research will be publicly available no later than publication acceptance of the main findings

Locations

PR (1)