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

NCT06896474 | Recruiting

• 1 other identifier: 24-565
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 11

Brief 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

Breast Cancer

Keywords

Breast Neoplasm; Breast Neoplasms; Breast Cancer; ER+ Breast Cancer

Outcome Measures

Primary Outcomes (4)

• Receipt of aggressive treatment within 6 months of First Surgical Encounter (Arm A)

  Research staff will review the medical records for all participants with eligible tumor and study characteristics seen by a participating surgeon during the trial to learn whether aggressive treatments were received (mastectomy, radiation treatment, sentinel lymph node biopsy \[SLNB\] or axillary dissections and/or systemic therapy) within 6 months of each participant's first surgical consultation.

  6 months

• Participant Perceived Shared Decision Making Quality Scale Score (Arm D)

  Assessed by the SDM Process Scale: 4 items-scored 0-4 with a total scores range of 0 to 8; patient/caregiver participant perspectives on how much surgeon reviewed reasons for having/not having radiotherapy after breast conserving surgery and for having SLNB. It also assesses if participants perceive being given a choice or asked about preferences.

  at 1 week

• Participant Perceived Shared Decision Making Quality Scale Score (Arm A)

  Assessed by the SDM Process Scale: 4 items-scored 0-4 with a total scores range of 0 to 8; patient/caregiver participant perspectives on how much surgeon reviewed reasons for having/not having radiotherapy after breast conserving surgery and for having SLNB. It also assesses if participants perceive being given a choice or asked about preferences.

  at 1 week

• Receipt of aggressive treatment within 6 months of First Surgical Encounter (Arm D)

  Research staff will review the medical records for all participants with eligible tumor and study characteristics seen by a participating surgeon during the trial to learn whether aggressive treatments were received (mastectomy, radiation treatment, sentinel lymph node biopsy \[SLNB\] or axillary dissections and/or systemic therapy) within 6 months of each participant's first surgical consultation.

  6 months

Secondary Outcomes (20)

• Participant Decisional Conflict Scale Score (Arm A)

  1 week

• Participant Decisional Conflict Scale Score (Arm D)

  1 week

• Participant Knowledge Score at 1 week (Arm A)

  1 week

• Participant Knowledge Score at 6 Months (Arm A)

  6 months

• Participant Knowledge Score at 1 week (Arm D)

  1 week

Study Arms (2)

Surgeons + SDM/DA

EXPERIMENTAL

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.

Behavioral: Shared Decision-Making Training and Decision Aid

Standard-of-Care

NO INTERVENTION

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.

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.

Also known as: SDM and DA

Surgeons + SDM/DA

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-resident surgeon \>18 years old
• Cares for women \>/= 70 years at one of the recruitment practices.
• Ability and willingness to provide verbal consent
• Biological female
• aged 70 or older
• first primary invasive breast cancer
• clinically \</=2 cm
• clinically lymph node negative
• estrogen receptor positive (ER+) -HER2-
• scheduled with a participating surgeon for an initial encounter. Females with ER+ breast cancer will be included regardless of their progesterone receptor (PR) status since treatment decisions are similar for ER+/PR+ and ER+/PR- women.
• Biological female
• aged 70 or older
• a first primary invasive breast cancer
• clinically \</=2 cm
• clinically lymph node negative

You may not qualify if:

• Resident surgeon
• Non-surgeons
• Psychiatric illness situations that would limit compliance with study requirements
• Age \<70
• Biological males: Biological males will be excluded since the data informing the DA were obtained from studies of biological females and treatment recommendations and outcomes tend to be worse for biological males with breast cancer.
• Non English or non-Spanish speaking: Women who do not speak English or Spanish will be excluded since these women are not eligible for the DA.
• History of invasive breast cancer
• History ductal carcinoma in situ treated with radiation (since these women are generally not be eligible for radiation treatment)
• Women with Paget's disease because treatment options differ
• inflammatory breast cancer because treatment options differ
• Phyllodes tumor because treatment options differ.
• In hospice
• Surgeon not willing to participate
• Age \<70
• Biological males: Biological males will be excluded since the data informing the DA were obtained from studies of biological females and treatment recommendations and outcomes tend to be worse for biological males with breast cancer.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (11)

Beckman Research Institute of the City of Hope

Los Angeles, California, 91010, United States

NOT YET RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

NOT YET RECRUITING

Beth Israel Deaconess Hospital

Needham, Massachusetts, 02492, United States

NOT YET RECRUITING

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

Weymouth, Massachusetts, 02198, United States

NOT YET RECRUITING

Rutgers State University of New Jersey Medical School

Newark, New Jersey, 07103, United States

NOT YET RECRUITING

University of New Mexico

Albuquerque, New Mexico, 87131, United States

NOT YET RECRUITING

University of Rochester

Rochester, New York, 14642, United States

NOT YET RECRUITING

Duke University

Durham, North Carolina, 27705, United States

NOT YET RECRUITING

Related Publications (51)

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

Decision Support Techniques; SDM

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Mara Schonberg, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mara Schonberg, MD

CONTACT

617-754-1414; mschonbe@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Cluster randomized controlled trial at the surgeon level

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 26, 2025
• Study Start: February 4, 2026
• Primary Completion (Estimated): October 1, 2032
• Study Completion (Estimated): September 30, 2033
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Data can be shared no earlier than one year following the date of publication or one year after completion of the grant.
• Access Criteria: All deidentified study data will be made available as public use data to the research community via a Harvard Dataverse Repository. Users will be required to agree to terms that prohibit unlawful uses and intentional violations of privacy, and require attribution. Use of the data will be otherwise unrestricted and free of charge.

Locations

US (11)