Background: Depression, pain, and fatigue are the three most common cancer-related symptoms. These symptoms lead to poorer quality of life, treatment non-adherence, higher unplanned health care utilization and costs, and reduced life expectancy. Yet only a minority of patients with these symptoms are screened and effectively treated. To address this gap, we (1) will use a cluster randomized trial to evaluate the real-world effectiveness of CARES, an integrated screening and stepped collaborative care intervention, to address these symptoms among cancer patients with these symptoms; (2) using the RE-AIM framework, conduct a robust evaluation of barriers and facilitators to CARES implementation and sustainability; (3) quantity the net costs and cost-effectiveness of CARES.
Methods: We will screen approximately 7500-10,000 patients for pain, fatigue, and depressive symptoms. Of those patients who report clinical levels of symptoms and consent to treatment, 1400 will be randomized, based on the clinic where they were screened, and treated with CARES or standard care (SC).
Results of Prior Research: In our prior Phase III efficacy trial, CARES improved the initiation of treatment (75% versus 4%). We also observed statistically and clinically significant improvements in HRQoL and symptom reduction. Patients randomized to CARES also had reductions in emergency room visits, readmissions, and length of stay in the hospital, and showed evidence of cost savings when compared to SC.
Conclusion: CARES has the potential to improve both cancer and non-cancer related outcomes among these patients while offering savings to the health system. This study will quantity whether CARES delivers on this promise and will offer insights into how to initiate and sustain similar programs in efforts to improve health of this vulnerable population.