Achieving Safe, Comprehensive, Digitally-Enabled Cancer Pain Management (ASCENT): Protocol for a Randomized Clinical Trial

Cancer patients and survivors disproportionately experience pain that impacts their quality of life. Evidence-based, multi-modal pain care (MMPC) strategies exist, but care models are needed that also account for the preferences, support, and social needs of patients. The Achieving Safe, Comprehensive, digitally-Enabled cancer pain managemeNT (ASCENT) study is a parallel-group randomized clinical trial testing the effectiveness of a digitally-enabled, collaborative care model (CCM)-based intervention that addresses uncontrolled pain and SDOH-related access barriers to evidence-based management. Eligible participants include rural-dwelling and/or Hispanic cancer patients with moderate to severe pain receiving care at one of the eight participating sites. Those randomized to the intervention receive a series of structured telephone/video calls delivered by a Pain Care Manager (PCM)- Community Health Worker (CHW) dyad for six months. Initial calls characterize patients’ pain and cancer histories, management preferences, and social determinant of health needs. A preference- and evidence-aligned Personalized Pain Management Program is developed for each participant and refined during subsequent calls. Patient-centered outcome measures (pain, functioning, mood, sleep, quality of life, pain catastrophizing) are collected from all participants at baseline, three-, and six- months. Pain, assessed with the Brief Pain Inventory, is our primary outcome. Healthcare utilization outcomes will include hospitalizations and emergency care visits. This ASCENT intervention offers a potentially scalable, remote approach to delivery of equitable, accessible pain management for rural-dwelling and/or Hispanic cancer patients who are susceptible to poor outcomes. This trial is registered on ClinicalTrials.gov NCT06198010: https://www.clinicaltrials.gov/study/NCT06198010?term=ASCENT&rank=4 .