This clinical trial evaluates whether adding an interactive 3-dimensional (3D) tool to a standard surgical consultation leads to greater patient satisfaction with the information provided about breast reconstruction than a standard surgical consultation alone. The interactive 3D tool displays 3-dimensional step-by-step animations of autologous and implant-based breast reconstruction procedures. Using the interactive 3D tool to teach patients about breast reconstruction options may lead to greater satisfaction with the information provided and with decisions made about the reconstruction procedure.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05025020.
PRIMARY OBJECTIVE:
I. To compare BREAST-Q satisfaction with information between patients who receive information about breast reconstruction procedures utilizing 3D interactive technology at the point of care (in addition to the standard of care) and patients who receive the standard of care alone.
SECONDARY OBJECTIVE:
I. To compare BREAST-Q satisfaction with breast, decision regret and decision quality index (DQI) between patients who receive information about breast reconstruction procedures utilizing 3D interactive technology at the point of care (in addition to the standard of care) and patients who receive the standard of care alone.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive a standard surgical consultation before their breast reconstruction procedure. Patients also complete questionnaires over 5-14 minutes before and after the consultation, and at 4 weeks and 3 months after surgery.
ARM II: Patients receive a standard surgical consultation and interactive 3D visualization tool before their breast reconstruction procedure. Patients also complete questionnaires over 5-14 minutes before and after the consultation, and at 4 weeks and 3 months after surgery.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorCarrie Stern