Lessons learned from conducting the first cancer care delivery trial in the Alliance for Clinical Trials in Oncology (Alliance A191402CD).

Abstract

Testing healthcare delivery interventions in rigorous clinical trials is a critical step in improving patient care, but conducting multisite randomized clinical trials to test the effect of care delivery interventions has unique challenges and requires foresight and planning. We conducted the first care delivery trial (A191402CD) in the Alliance for Clinical Trials in Oncology, a National Cancer Institute Community Oncology Research Program research base, which tested the effectiveness of two different decision aids for supporting shared decision-making about prostate cancer treatment. Our experience illustrates the kind of challenges that confront care delivery researchers as they seek to test interventions to improve the experiences of patients. Lessons learned include the following: cluster-randomized designs introduce complexity; workflow disruption can discourage site participation; evidence-based methods may not always be sufficient. We conclude with the following recommendations: assessing feasibility requires special rigor; relationships and interpersonal dynamics must be leveraged. Our experiences may inform future care delivery research.