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

Conditions

• Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Shared Decision-Making Training and Decision Aid — BEHAVIORAL
  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.

Study Details

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.

Key Dates

Start date

Feb 4, 2026

Status verified

Feb 2026

Primary completion

Oct 1, 2032

Completion

Sep 30, 2033

Study Design

Enrollment

402 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Experimental: Surgeons + SDM/DA
  22 enrolled surgeon participants will be randomized and will complete: * Baseline questionnaire * Virtual 1 hour training on SDM * 3-month training follow up survey * At Month 12: 6 surgeon participants will take part in a semi-structured interview with research assistant/PI by phone, in-person, or virtually * End-of-study survey * At end of study 6 surgeon participants will take part in a semi-structured interview with research assistant/PI by phone, in-person, or virtually. Approximately, 153 patients and 17 caregivers will be in this arm. They will complete a survey at 1 week and 6 months. At 12 months investigators will ask 12 patients and 4 caregivers to complete a qualitative interview. At end of study investigators will ask 12 patients and 4 caregivers to complete a qualitative semi-structured interview with research assistant/PI by phone, in-person, or virtually.
• No Intervention: Standard-of-Care
  22 enrolled surgeons will be randomized to usual care and will complete: * Baseline questionnaire * End-of-study survey * May choose to participat in End-of-study virtual 1 hour training on SDM * 3-month training follow up survey evaluating the training Approximately, 153 patients and 17 care-givers will be in this arm. They will complete a survey at 1 week and 6 months.

Primary Outcome Measure

Receipt of aggressive treatment within 6 months of First Surgical Encounter (Arm A) [ Time Frame: 6 months ]

Central Contacts

• Mara Schonberg, MD
  617-754-1414
  [email protected]

Locations (11)

Find similar trials in Los Angeles, CA

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