Actively Recruiting
SDM POSSIBLE: A Breast Cancer Treatment Decision Aid for Women 70+ With Low-Risk Stage I Breast Cancers
Led by Beth Israel Deaconess Medical Center ยท Updated on 2026-04-07
402
Participants Needed
11
Research Sites
399 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
SDM POSSIBLE: A Breast Cancer Treatment Decision Aid for Women 70+ With Low-Risk Stage I Breast Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Surgeon is 18 years or older and not a resident
- Surgeon cares for women aged 70 or older at a participating site
- Surgeon willing and able to provide verbal consent
- Female patients aged 70 or older
- First primary invasive breast cancer diagnosis
- Breast cancer clinically 2 cm or smaller
- Clinically lymph node negative breast cancer
- Estrogen receptor positive, HER2 negative breast cancer
- Scheduled for an initial encounter with a participating surgeon
- Primary caregiver aged 18 or older, English or Spanish speaking, able and willing to consent (if patient unable to participate)
- Allied health professionals involved in breast surgery willing to consent
You will not qualify if you...
- Resident surgeons or non-surgeons
- Psychiatric illness limiting study compliance
- Patients younger than 70 years
- Biological males
- Non-English and non-Spanish speaking patients
- History of invasive breast cancer
- History of ductal carcinoma in situ treated with radiation
- Paget's disease, inflammatory breast cancer, or phyllodes tumor
- Patients currently in hospice care
- Surgeons unwilling to participate
- Patients with dementia or incapacity for informed consent
- Patients exceeding monthly recruitment limits for non-Hispanic white individuals
- Primary caregivers younger than 18 years or non-English/Spanish speaking
- Allied health professional trainees or with psychiatric illness limiting compliance
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Beckman Research Institute of the City of Hope
Los Angeles, California, United States, 91010
Not Yet Recruiting
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
5
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
Not Yet Recruiting
6
Beth Israel Deaconess Hospital
Needham, Massachusetts, United States, 02492
Not Yet Recruiting
7
Dana-Farber/Brigham and Women's Cancer Center at South Shore Hospital
Weymouth, Massachusetts, United States, 02198
Not Yet Recruiting
8
Rutgers State University of New Jersey Medical School
Newark, New Jersey, United States, 07103
Not Yet Recruiting
9
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Not Yet Recruiting
10
University of Rochester
Rochester, New York, United States, 14642
Not Yet Recruiting
11
Duke University
Durham, North Carolina, United States, 27705
Not Yet Recruiting
Research Team
M
Mara Schonberg, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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