A Randomized Trial of Shared Decision Making Training and a Breast Cancer Treatment Decision Aid for Women 70 and Older with Low-Risk Stage I Breast Cancer

What this Trial Is About

Researchers are conducting a cluster randomized clinical trial to evaluate a multi-level intervention involving shared decision making training for breast surgeons and a patient decision aid for women aged 70 and older with low-risk Stage I breast cancer. This study aims to improve treatment decisions and outcomes by supporting communication between surgeons and older women facing breast cancer treatment choices. The trial is being conducted across seven large health systems in the U.S. The intervention includes a one-hour shared decision making training for surgeons and providing eligible patients with a tailored decision aid before their first surgical visit. Surgeons randomized to the intervention arm receive training via live televideo or video recording and ongoing support including access to decision tools and feedback on challenging cases. Patients receive the decision aid by mail, email, or patient portal. Surgeons in the usual care arm continue their standard treatment discussions without additional support. The study plans to recruit 44 surgeons and over 1,100 women over three years. Participants will be observed through medical record reviews to determine treatments received and outcomes such as breast cancer recurrence and survival over 6 months to 3.5 years. Patients and caregivers will complete surveys at one week and six months after the initial surgical visit to report on shared decision making quality, knowledge, decisional conflict, quality of life, and treatment satisfaction. Surgeons will complete baseline and end-of-study surveys, with some participating in interviews to provide feedback. The study will also assess healthcare costs and the feasibility of implementing the intervention in clinical practice.

SDM POSSIBLE: A Breast Cancer Treatment Decision Aid for Women 70+ With Low-Risk Stage I Breast Cancers