RecruitingNot ApplicableNCT06896474

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

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


Sponsor

Beth Israel Deaconess Medical Center

Enrollment

402 participants

Start Date

Feb 4, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is developing and testing a decision-support tool (called SDM POSSIBLE) to help women aged 70 and older with low-risk, early-stage breast cancer and their surgeons make informed decisions together about treatment options — including whether surgery, radiation, or hormone therapy alone might be appropriate. The goal is to ensure older women understand all their options and feel empowered to choose the approach that best fits their values and health situation. **You may be eligible if...** - You are a biological female aged 70 or older - You have been diagnosed with your first primary invasive breast cancer - Your cancer is early stage and low-risk (meets specific clinical criteria) - You are seeing a surgeon at one of the participating clinics **You may NOT be eligible if...** - You have had breast cancer before - Your cancer is higher risk or more advanced than the study criteria allow - You are not a patient at a participating practice - You are unable to complete study surveys or interviews Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALShared 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.


Locations(11)

Beckman Research Institute of the City of Hope

Los Angeles, California, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Beth Israel Deaconess Hospital

Needham, Massachusetts, United States

Dana-Farber/Brigham and Women's Cancer Center at South Shore Hospital

Weymouth, Massachusetts, United States

Rutgers State University of New Jersey Medical School

Newark, New Jersey, United States

University of New Mexico

Albuquerque, New Mexico, United States

University of Rochester

Rochester, New York, United States

Duke University

Durham, North Carolina, United States

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NCT06896474


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