A multilevel intervention to improve adherence to prostate cancer active surveillance versus usual care: results from a pilot randomized controlled trial

Active surveillance is the primary management strategy for men with low-risk prostate cancer and yet, adherence to active surveillance remains suboptimal. Men choose to receive surgery or radiation therapy even without any evidence of their cancer progressing or because of anxiety. Novel interventions to improve adherence are needed.

We designed and implemented a pilot randomized clinical trial comparing usual care (control) versus a multilevel intervention (Management of Active surveillance in Prostate cancer [MAP] for patients with low-risk prostate cancer and their primary care providers (PCPs) between November 2022 and May 2023. Our primary outcomes were feasibility (defined by enrollment and survey completion rates) and acceptability (assessed by a participant satisfaction survey). Exploratory outcomes included additional surveys and interviews assessing patient- and PCP-reported measures. Eligible patients were adult men > 55 years old diagnosed with low-risk prostate cancer on active surveillance. Eligible PCPs were identified by enrolled patients. For the intervention arm, participants had access to a personalized website addressing barriers to adherence (knowledge, provider roles in team-based care delivery, managing cancer-related anxiety). PCPs of patients in the intervention arm received a templated visit summary from the urologist with the recommended active surveillance care plan.

Thirty-five patients were randomized and survey completion rate across both arms was 86%. Overall, 70% of intervention arm participants found MAP acceptable. Patients in the intervention arm (versus control) were more likely to prefer either PCP or urologist (versus urologist only) for various aspects of active surveillance care at 6-months. Other exploratory patient-reported outcomes were similar across arms.

This study demonstrated a multilevel intervention (MAP) is feasible to deploy and acceptable. Importantly, MAP shows promise in building patient confidence about team-based active surveillance care delivery and increased primary care involvement through targeted education around the role or primary care.

ClinicalTrials.gov identifier NCT05764005.