A Randomized Controlled Trial to Assess the Use of a Virtual Decisional Aid to Improve Knowledge and Patient Satisfaction in Women Considering Breast Reconstruction Following Mastectomy.

Background The decisional process of navigating breast reconstruction surgery is very challenging for patients with a breast cancer diagnosis. This study aims to assess the impact of a virtual breast reconstruction decision aid program on the decision-making process of breast cancer patients considering breast reconstruction.  Methods A two-arm, randomized, controlled trial was conducted at the University of Pittsburgh. Patients were blindly assigned to one of two arms: Emmi Decide (Emmi Solutions LLC, Chicago, IL) program prior to traditional consultation (intervention) and traditional consultation alone (control). All patients completed a baseline pre- and post-intervention questionnaire to evaluate knowledge, patient satisfaction, and psychological status. Surgeons' satisfaction and consultation time were also recorded. Results A total of 26 patients participated in the study (n=13 in each arm). Patients in the intervention group reported a greater BREAST-Q reconstruction module score (control=47.9±8.2, intervention=56.8±4.2, p=0.0017), lower decisional conflict scale score (control=30.2±11.8, intervention=14.5±8.8, p=0.017), and improved patient knowledge (control=70.8±15.5%, intervention=83.1±13.8%, p=0.018). No difference was noted in consultation time (control=51.0±7.8 min, intervention=47.8±13.7 min, p=0.46) and psychological testing (control=49.7±16.0, intervention=44.6±15.2, p=0.26). However, surgeons reported greater satisfaction with their consultations with interventional group participants (control=3.4±0.7, intervention=4.8±0.4, p=0.000056). Conclusions The use of a virtual decisional aid program to assist the decision-making of breast reconstruction patients was shown to significantly benefit both patients and surgeons, by improving patient knowledge and satisfaction without placing an additional psychological burden on them. This supports the notion that this resource is a promising tool that can improve the difficult process of breast reconstruction in the vulnerable population of breast cancer patients.

RCT Entities:   Population Interventions Outcomes