Abstract P2-08-22: Effectiveness and implementation of a decision support tool to improve surgical decision-making in young women with breast cancer: The CONSYDER Study

Background: Young women with early-stage breast cancer are increasingly choosing contralateral prophylactic mastectomy (CPM) despite longstanding data demonstrating that breast conservation is equally effective as mastectomy, with comparable overall and disease-specific survival. Life-stage specific factors (e.g., breastfeeding, body image) can make surgical decisions particularly complex for young women and young women report high levels of decisional conflict regarding the surgical decision. The use of decision support tools has been shown to improve decision quality and reduce decisional regret. To optimally support young women making decisions about breast cancer surgery, we developed CONSYDER, a web-based decision aid (DA) tailored to the unique concerns of young patients. We aimed to test the effectiveness and implementation of the DA in a multi-center, pragmatic trial. Methods: The CONSYDER Study incorporates a Type II hybrid effectiveness-implementation, stepped-wedge design. Using a mixed-methods approach, including surveys, interviews, focus groups, and audio-recordings with patients and providers, we will test the efficacy and evaluate the implementation of the CONSYDER DA across 4 sites (Weill Cornell Medicine, Yale Cancer Center, Dana-Farber Cancer Institute, Duke Cancer Institute) over a 30-36 month period. Eligibility criteria include: female and age 18-44 years with a new diagnosis of stage 0-III unilateral breast cancer. All sites have a 6-month “run-in” period (T1) where patients will not be sent the DA. Sites will then be randomized to begin delivery of the DA as part of standard clinical care during subsequent 6-month blocks (T2, T3, T4, or T5). The primary study aims are to: 1) test the effectiveness of the DA on reducing patient-reported decisional conflict (assessed by the Decisional Conflict Scale [DCS]) prior to breast cancer surgery; 2) evaluate the implementation and mechanisms of DA use. Secondary aims include determining the impact of the DA on decision-making preferences, breast cancer knowledge, treatment goals and preferences, anxiety, decisional regret, and self-efficacy in communication. An exploratory aim will evaluate how the DA impacts surgical choice. A sample size of 800 patients (200 per site) was selected to have approximately 80% power to detect a minimum effect size of 0.35 (clinically meaningful DCS effect sizes range 0.3 to 0.4). For the primary endopoint, we will use generalized linear models to assess if the DCS score differs between the intervention and usual care groups. An assessment for differential effects of the DA on women of different races, ethnicities, and ages (e.g., 40-44 vs. 35-39 vs. <35) will be performed by testing for a treatment by variable (e.g., race, ethnicity, age group) interaction, assuming sufficient accrual numbers for different patient subsets. As part of the implementation evaluation, we will perform semi-structured interviews with a subset of participants. Surgeon attitudes and approaches around discussing surgical options will be evaluated with a survey of surgeons prior to the implementation of the DA and at the end of the study. To complement the surgeon surveys, we will randomly sample a subset of surgeons at each site post-implementation and audio-record 4-8 consultations per surgeon to characterize how the DA may impact patient-provider communication and shared surgical decisions. We will also conduct interviews and focus groups with providers/staff involved with the delivery of the DA about perceived barriers to DA implementation at their site/practice and opportunities to improve sustainability. The CONSYDER Study opened to enrollment in March 2024. As of June 2024, 57 participants are enrolled. Clinical Trials Information: NCT06275126Citation Format: Shoshana Rosenberg, Yushu Shi, Anna Revette, Lindsay Northrop, Laura Dominici, Jennifer K. Plichta, E. Shelley Hwang, Karen Sepucha, Maryam Lustberg, Lisa Newman, Ann H. Partridge, Rachel A. Greenup. Effectiveness and implementation of a decision support tool to improve surgical decision-making in young women with breast cancer: The CONSYDER Study [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P2-08-22.

Duke Scholars

Author Jennifer K Plichta Surgical Oncology