JNCI cancer spectrum · 2026
Evaluating a shared decision engagement system in the NCI community oncology research program: a multi-level RCT.
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Hawley Sarah T, Kidwell Kelley M, Jagsi Reshma, Barber Anne K, Wills Rachel, Chow Selina L, Kour Oudom, Segovia Diana, Abrahamse Paul, Resnicow Ken, Zikmund-Fisher Brian J, Hofer Timothy P, Neuman Heather B
Аннотация
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.
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.