Grant Number:	1R01CA296402-01 Interpret this number
Primary Investigator:	Steel, Jennifer
Organization:	University Of Pittsburgh At Pittsburgh
Project Title:	Hybrid Type I Cluster Randomized Effectiveness-Implementation Trial of Cares
Fiscal Year:	2025

Over 18 million Americans are living with cancer. Half of them report clinically significant levels of depression, pain, and/or fatigue. According to the NIH consensus statement, these are the three most common and distressing cancer-related symptoms. These symptoms lead to poorer health-related quality of life (HRQoL) and cancer-related treatment adherence, higher unplanned health care utilization and costs, and reduced life expectancy. While the implementation of screening for these symptoms has been successful in many cancer centers, only a minority of the patients initiate treatment after being referred. As a result, the current standard of care (SC) has not been effective at improving HRQoL in those diagnosed with cancer. Our team has developed, and tested, an integrated EHR-based screening and stepped collaborative care intervention (here after, CARES) to address this barrier to treatment, as well as address health disparities previously observed in EHR-based screening. In our Phase III efficacy trial, CARES improved the initiation of treatment (75% versus 4%) and statistically and clinically significant improvements in HRQoL was observed. Patients randomized to CARES also had reductions in emergency room visits, readmissions, and length of stay in the hospital, and cost savings of $17,085 per patient per year when compared to SC. The overarching objective of the proposed study is to move CARES from research to routine clinical care. We plan to test the effectiveness of CARES in a pragmatic trial or “real world” setting. We will also conduct an implementation-focused process evaluation of patient and clinician engagement with CARES guided by the RE-AIM framework. Finally, to prepare to disseminate the intervention, we will perform a full cost-effectiveness analysis of CARES. To meet these goals, we propose a Hybrid Tye I effectiveness-implementation cluster randomized trial of CARES. The UPMC Hillman Cancer Center is an ideal setting to evaluate the effectiveness and implementation of CARES secondary to the research and clinical infrastructure which includes over 100,000 individuals evaluated and treated each year for cancer. We will randomize >34 outpatient oncology clinics to CARES (>17) or the SC (>17). The specific aims are to: (1) evaluate the effectiveness of CARES for improving patient centered outcomes in a cluster randomized trial; (2) conduct a robust evaluation of the implementation of CARES, guided by the RE-AIM framework, which includes patient, clinician, organizational facilitators, and barriers, to engagement; (3) examine the net costs and cost-effectiveness of CARES. The goals of the study reflect the mission of the National Cancer Institute which includes testing strategies to overcome barriers to the adoption, effectiveness, scaling-up, and sustainability of evidenced-based interventions that will improve the quality of life of patients with cancer. This study will advance the implementation of guideline concordant care (screening and treatment) and has the potential to shift the practice of screening and treatment paradigm nationwide resulting in improved outcomes for those diagnosed with cancer.





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