Evaluating a shared decision engagement system in the NCI community oncology research program: a multi-level RCT
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 NeumanAbstract
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 was carried out in collaboration with the NCI Community Oncology Research Program Alliance Research Base to evaluate a multi-level intervention in a crossed design: 1) a patient-level randomized intervention of the evidence-based iCanDecide online tool with added emotional support enhancements (iCanDecide-ESE), intended to promote better information uptake by supporting management of distress associated with a new diagnosis vs. the standard version (iCanDecide-S); 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), cancer worry and breast cancer self-efficacy (key secondary outcomes). We evaluated outcomes using linear mixed models considering the nesting of individuals within clinic across time periods.
Results
We enrolled 542 (403 evaluable) patients and 54 clinicians across 25 surgical clinics. The confidence intervals for all outcomes included zero but excluded pre-specified 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 NCORP sites, clinicians and patients with the study and intervention components suggests future cancer care delivery studies could leverage implementation strategies to promote multi-level patient-centered communication interventions.
Trial registration
ClinicalTrials.gov NCT04549571. Registered on 16 September 2020.