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NCT Number: NCT07219264

Mental Health CPR for Cancer Survivors

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

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Key information

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ponce Medical School Foundation, Inc.

Ponce, Puerto Rico, 00732

Location status: Recruiting

Location contact

Eida M Castro-Figueroa, PsyD, MSc

PRINCIPAL_INVESTIGATOR

Guillermo N Armaiz-Pena, PhD

PRINCIPAL_INVESTIGATOR

Jean M Torres Vazquez, ENG

CONTACT

[email protected]

787-840-2575 ext. 4793

About this study

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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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)

  3. 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.

Secondary outcomes

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

    Time frame: 9 months

    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)

  2. Communication and Caregiving Assessment Tool (Caregiver Form - CCAT-CF)

    Time frame: 9months

    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)

  3. Self-Stigma of Mental Illness Scale (SSMIS)

    Time frame: 9 months

    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)

  4. Psychological distress, assessed with the Hospital Anxiety and Depression Scale (HADS)

    Time frame: 9 months

    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)

  5. Health-Related Quality of Life assessed with the Functional Assessment of Cancer Therapy - General (FACT-G, Version 4)

    Time frame: 9 months

    The Functional Assessment of Cancer Therapy - General (FACT-G, Version 4) is a validated 27-item questionnaire developed by Cella et al. (1993) that measures health-related quality of life in cancer patients across four domains: Physical, Social/Family, Emotional, and Functional Well-Being. Each item is rated on a 5-point Likert-type scale (0-4). Higher scores indicate better quality of life.

    Population: Adult cancer survivors enrolled in the Mental Health CPR study. Unit of Measure: Mean FACT-G total score (range 0-108)

  6. Perceived Social Support, asses with Multidimensional Scale of Perceived Social Support (MSPSS)

    Time frame: 9 months

    The Multidimensional Scale of Perceived Social Support (MSPSS), developed by Zimet et al. (1988), is a validated 12-item self-report questionnaire that measures perceived social support from three sources: family, friends, and significant others. Each item is rated on a 7-point Likert scale (1 = very strongly disagree to 7 = very strongly agree). Higher total scores indicate greater perceived social support. Mean MSPSS total score (range 1-7)

  7. Brief Resilience Scale (BRS)

    Time frame: 9 months

    The Brief Resilience Scale (BRS), developed by Smith et al. (2008), is a 6-item self-report questionnaire designed to assess the ability to recover from stress. Items are rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Higher scores reflect greater resilience. Mean BRS total score (range 1-5)

  8. Salivary Stress Hormone Levels (Cortisol and Alpha-Amylase)

    Time frame: 9 months

    Salivary cortisol and alpha-amylase levels will be measured as biomarkers of physiological stress response. Saliva samples will be collected from participants at baseline and post-intervention following standardized collection procedures (e.g., morning fasting samples). Samples will be stored and analyzed in a blinded laboratory setting using enzyme-linked immunosorbent assay (ELISA) and kinetic enzyme assays. Higher cortisol and alpha-amylase concentrations indicate higher physiological stress activation. Laboratory personnel conducting assays are blinded to participants' group assignments. Mean salivary cortisol (µg/dL); mean salivary alpha-amylase (U/mL)

  9. Salivary Cytokine and Chemokine Concentrations

    Time frame: 9 months

    Salivary cytokine and chemokine concentrations will be analyzed as biomarkers of inflammation and immune activation associated with stress response. Samples will be collected using standardized saliva collection procedures and stored at -80°C until analysis. Laboratory assays will be performed using multiplex immunoassay or enzyme-linked immunosorbent assay (ELISA) methods to quantify cytokines (e.g., IL-6, IL-10, TNF-α) and chemokines (e.g., MCP-1, IL-8). All laboratory personnel conducting the analyses are blinded to participants' group assignments to ensure unbiased outcome assessment. Higher concentrations reflect greater inflammatory response. Mean concentration (pg/mL)

Study contacts

Contact information is provided by the study sponsor or research team.

Eida M Castro-Figueroa, PsyD, MSc

CONTACT

[email protected]

787-840-2575 ext. 2166

Guillermo N Armaiz-Pena, PhD

CONTACT

[email protected]

787-840-2575 ext. 3226

Sponsors and collaborators

Lead sponsor

Ponce Medical School Foundation, Inc.

Industry

Collaborators

  • University of Puerto Rico Medical Sciences Campus
  • University of Rochester

Registry information

Official study title

Mental Health CPR: Transforming Cancer Survivors' Mental Health With Community Participatory Reach

Acronym: MH-CPR CaS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 21, 2025
Registry last updated
Oct 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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