Grant Number:	5U01CA290611-02 Interpret this number
Primary Investigator:	Penedo, Frank
Organization:	University Of Miami Coral Gables
Project Title:	Implementation of Comprehensive Survivorship Care Intervention Across Fqhc-Based Primary Care Practices
Fiscal Year:	2025

Cancer survivorship challenges adversely contribute to cancer burden, morbidity and mortality, and are exacerbated by multiple health care and contextual barriers such as oncology provider shortages, and limited comprehensive survivorship care services in primary care (PC). There is a critical need to integrate comprehensive survivorship care (i.e., care coordination, prevention, surveillance and intervention) in PC settings, given a growing demand for acute cancer care by oncologists, which has shifted the need to deliver essential survivorship care in PC clinics. The rising shift towards follow-up care in PC requires that survivorship care in those settings effectively implement and promote comprehensive survivorship care (CSC): including adherence to best practice guidelines, care coordination and management of physical, psychosocial and practical needs, attention to lifestyle behaviors and self-management, and optimal surveillance for new primary cancers and/or recurrences. However, evidence-based interventions that implement these care processes to provide risk-stratified optimal care for survivors and address unmet needs of this growing population in PC are critically lacking, particularly in community-based PC clinics with survivors primarily from communities with limited access to care. Guided by the EPIS implementation and RE-AIM evaluation frameworks, we propose a Type II effectiveness-implementation hybrid study with a cluster randomized clinical trial to implement PC clinician training, and evaluate survivorship standard of care (SOC; e.g., survivorship care plans), relative to a comprehensive survivorship care (CSC+SOC) intervention, on: (a) unmet needs, health-related quality of life, lifestyle behaviors (primary outcomes), and (b) screening, health care utilization and care quality (secondary outcomes) across 14 community clinics part of the Health Choice Network (HCN) Federally Qualified Health Centers (FQHCs) in South Florida that provide PC to South Florida communities with limited access to cancer survivorship care. We will recruit 100 PC clinicians, 20 clinic and HCN leaders, and 930 adult survivors. Our aims are: (Aim 1) Train clinicians in the SOC and CSC conditions to establish the components of the experimental conditions and finalize the necessary infrastructure in the HCN clinics; (Aim 2) Conduct a cluster randomized trial (3 FQHC systems with 14 clinics) that will evaluate the effectiveness of SOC vs. CSC conditions on survivors’ unmet needs, HRQoL, lifestyle health and health care utilization and satisfaction; and (Aim 3) Evaluate implementation and sustainability of CSC for future dissemination by assessing determinants of successful implementation. The research team has expertise across critical areas targeted in this U01 (e.g., psychosocial and medical oncology, primary care, health services research, e/mHealth, EMR-integrated assessment and intervention, community health). The 14 FQHC clinics served over 4,300, older (80% >50 yrs. old) survivors representing our cancer center’s catchment area.





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