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Evaluating a shared decision engagement system in the National Cancer Institute Community Oncology Research Program: a multi-level randomized controlled trial

Year: 2026
Type: article
Study design: Clinical Trial
Abstract: BACKGROUND: Improving patient-centered care and communication in breast cancer remains challenging in the complex and evolving landscape of breast cancer care delivery. METHODS: The SharES (Alliance A231901CD) trial (ClinicalTrials.gov NCT04549571) was carried out in collaboration with the Alliance National Cancer Institute Community Oncology Research Program Research Base to evaluate a multilevel intervention in a crossed design: (1) a patient-level randomized intervention of the evidence-based iCanDecide online tool with added emotional support enhancements, intended to promote better information uptake by supporting management of distress associated with a new diagnosis vs the standard version, and (2) a clinic-level stepped-wedge randomized clinician dashboard intervention. Patient-reported outcomes assessed 5 weeks after registration were knowledge about breast cancer locoregional treatment (primary outcome), with cancer worry and breast cancer self-efficacy as key secondary outcomes. We evaluated outcomes using linear mixed models, considering the nesting of individuals within the clinic across time periods. RESULTS: We enrolled 542 (403 evaluable) patients and 54 clinicians across 25 surgical clinics. The CIs for all outcomes included zero but excluded prespecified clinically important differences in the knowledge score. We found good fidelity to the intervention components and considerable variation in the primary outcome across sites. CONCLUSIONS: The addition of emotional support components to a patient support tool previously found effective is unlikely to result in clinically important improvements in knowledge, cancer worry, or breast cancer self-efficacy. The strong engagement of National Cancer Institute Community Oncology Research Program sites, clinicians, and patients with the study and intervention components suggests future cancer care delivery studies could use implementation strategies to promote multilevel patient-centered communication interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT04549571.
DOI: 10.1093/jncics/pkag100
Authors: Sarah T Hawley, Kelley M Kidwell, Reshma Jagsi, Anne K Barber, Rachel Wills, Selina L Chow, Oudom Kour, Diana Segovia, Paul Abrahamse, Ken Resnicow, Brian J Zikmund-Fisher, Timothy P Hofer, Heather B Neuman
Institutions: University of Michigan, Michigan Medicine, VA Center for Clinical Management Research, Emory University, American College of Surgeons, Mayo Clinic, University of Minnesota, University of Wisconsin–Madison
Language: English
Open Access status: gold
Estimated APC paid: $2,050
Awards: Ozark Health Ventures LLC dba Cancer Research for the Ozarks (CRO), Kaiser Permanente NCI National Community Oncology Research Program, NCORP, Improving Patient-Centered Communication in Breast Cancer: A RCT of a Shared Decision Engagement System (ShaDES), MINORITY-BASED COMMUNITY ONCOLOGY PROGRAM, Columbia University Minority/Underserved Site NCI Community Oncology Research Program, Alliance NCORP Research Base, Sanford Community Cancer Program of the North Central Plains (NCORP), Columbus NCORP RFA-CA-18-016, Michigan Cancer Research Consortium NCORP, Aurora NCORP Community Site, Baptist Memorial Health Care/Mid South NCORP Minority Underserved Consortium, STEREOCHEMISTRY OF THIOL-DISULFIDE INTERCHANGES, Wisconsin NCI Community Oncology Research Program (WiNCORP), Delaware Christiana Care NCORP, University of Michigan Rogel Cancer Center Support Grant 2023-2028, MaineHealth Cancer Care Network (MHCCN) and NCORP Activities across the Lifespan
OpenAlex ID: W7214670032
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Cites: 24
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Related to: 10