Clinical trials

Specific Aim 1: Determine the effect of CASA on psychological distress (primary outcome) and on neuroendocrine, inflammatory, and translational control measures (secondary and exploratory outcomes) in LSBC-PR patients and caregivers. We will conduct a two-arm randomized controlled trial of 70 patient caregiver dyads (35 per arm; N=140 individuals) comparing CASA to usual care, with assessments at baseline (T1) and post-intervention (T2, 5 to 10 weeks). This sample provides 80% power (a=0.05, two-tailed) to detect d=0.80 on the primary outcome, consistent with ORBIT Phase 3 signal confirmation. Psychological distress (Distress Thermometer) is the primary outcome and depressive symptoms (PHQ-8) the secondary psychosocial outcome; patients are the primary analytic unit, with caregivers analyzed in parallel. Plasma cortisol is the key secondary biological outcome; inflammatory cytokines (IL-6, TNF-a, IL-1B, IFN-v, IFN-a, IP-10, CRP) are secondary biological outcomes tested with Benjamin Hochberg FDR control; polysome profiling of PBMCs (with Dr. Dharmawardhane, UPR-MSC) is exploratory. Outcomes are tested hierarchically to control family-wise error. Recruitment, intervention delivery, and biospecimen collection will be conducted at the Puerto Rico Biobank (PRBB) under PMSF-PRI IRB oversight, leveraging Alliance partner collaboration (UPR-MSC and PMSF-PRI). Expected Outcome: CASA will produce greater reductions in psychological distress than usual care, with signals in cortisol and inflammatory cytokines that inform a fully powered R01 to confirm stress-biology mechanisms in LSBC-PR dyads. Specific Aim 2: Develop and validate a multilevel implementation strategy for CASA informed by implementation science determinants and stakeholder co-design. Using mixed methods, Consolidated Framework for Implementation Research (CFIR) guided semi-structured interviews (n=20) with oncology and clinic-based stakeholders will be supplemented by validated measures of acceptability, feasibility, and appropriateness. Determinants will be mapped to Expert Recommendations for Implementing Change (ERIC) strategies; co-design sessions will produce a context-specific implementation blueprint. Expected Outcome: A stakeholder-validated implementation strategy that identifies key determinants of CASA uptake and provides an actionable roadmap for scalable delivery across Puerto Rican oncology settings.

This study evaluates the effectiveness of a culturally tailored intervention, Bridges to Better Health and Wellness (BRIDGES), aimed at reducing chronic disease disparities among Puerto Ricans with serious mental illness (SMI). Participants receive monthly sessions with health care managers to address patient-provider stigma and care coordination.

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

The team aims to test the effectiveness of an intervention to increase gender-affirming cervical cancer prevention behaviors targeted at medical students studying in Puerto Rico and Florida. The team expects that after exposure to the intervention, relative to the control group, participants in the experimental condition will manifest more favorable changes in knowledge, attitudes, and behaviors of adequate care towards Latinx transmasculine and non-binary people.