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The United States Veterans Affairs (VA) Health Care System has a strong history of conducting impactful oncology randomized clinical trials (RCTs). We developed a phase II/III RCT to test the use of metastasis-directed therapy in Veterans with oligometastatic prostate cancer (OMPC)-the first VA RCT in OMPC that leverages novel imaging and advanced radiotherapy techniques. To accomplish this, we developed a clinical trial network to conduct the study. In this manuscript, we describe several challenges we encountered in study development/conduct and our strategies to address them, with the goal of helping investigators establish robust study networks to conduct clinical trials. In the study start-up, we encountered challenges in timely site activation, and leveraged project management to maximize efficiency. Additionally, there were several changes in the clinical paradigms in imaging and treatment that led to protocol amendments to ensure maximum equipoise, recruitment, and impact of the study. Specifically, we amended the trial to add de novo OMPC patients (from initially only recurrent OMPC) and expanded the study to allow up to 10 metastases (from initially five). Finally, in order to maintain local study team engagement, we developed initiatives to maximize collaboration and add value to the overall clinical program through study participation.

Background: Total joint arthroplasties are common orthopedic surgeries that carry risk for developing chronic post-surgical pain. In addition to pre- and post-operative pain severity, psychological distress (e.g., anxiety, pain catastrophizing) is a risk factor for chronic postsurgical pain. Cognitive behavioral therapy (CBT) for chronic pain is an empirically supported approach to managing chronic pain, functional impairment, and related distress. While CBT has been used extensively in patients with established chronic pain, using it as a preventive intervention targeting the transition from acute to chronic postsurgical pain is a novel application., Objectives: The Perioperative Pain Self-Management (PePS) program is a pain self-management intervention based on the principles of CBT. This innovative intervention is brief, flexible, and is delivered remotely. The current study aims to determine the efficacy of PePS compared to standard care on reducing the incidence of significant surgical site pain at 6-months post-surgery. The current study also aims to evaluate the context for subsequent implementation., Methods: This study is a hybrid type I efficacy-preparing for implementation trial. It is a two-site, single-blind, two-arm, parallel, randomized control trial. Surgical patients will be randomized to either receive: 1) PePS plus standard care, or 2) Standard care. The primary end point will be surgical site pain severity at 6-months post-surgery., Conclusion: Results from this study are expected to result in support for a brief scalable intervention (PePS) that can prevent the development of chronic pain and prolonged post-surgical opioid use, as well as key details to inform subsequent implementation., Clinicaltrials: govIdentifier:NCT04979429., (Published by Elsevier Inc.)