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

NCT06896474 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2026-04-07

No results posted yet for this study

Summary

Investigators aim to conduct a type 1 hybrid effectiveness-implementation surgeon-level cluster randomized clinical trial (RCT) of a multi-level intervention, a shared decision making training for surgeons plus patient decision aid vs. usual care (UC), at 7 large health systems across the U.S. to learn the intervention's effectiveness. Decision aids will be mailed and sent via patient portal and/or via email (when portal/email addresses are available) to patients before their first surgical encounter. The central hypothesis is that the novel intervention will be a key resource to support shared decision making leading to higher quality treatment decisions and as result improved care and outcomes.

Conditions

Interventions

BEHAVIORAL

Shared Decision-Making Training and Decision Aid

The intervention includes training surgeons in shared decision making techniques and providing eligible participants with a tailored breast cancer treatment decision aid prior to the initial surgical consultation.

Sponsors & Collaborators

Principal Investigators

  • Mara Schonberg, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-04
Primary Completion
2032-10-01
Completion
2033-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06896474 on ClinicalTrials.gov