Related Experiment Videos
Evaluating a shared decision engagement system in the NCI community oncology research program: a multi-level RCT
Sarah T Hawley1,2,3, Kelley M Kidwell4, Reshma Jagsi5
1Division of General Medicine, Department of Medicine, University of Michigan, Ann Arbor MI, USA.
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.