Recruiting

Shared Decision Making

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT06896474

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Shared Decision-Making Training and Decision Aid

Study Details

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

Study ID

NCT06896474

Start date

Feb 4, 2026

Status verified date

Feb, 2026

Completion date

Sep 30, 2033

Anticipated

Primary completion date

Oct 1, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Surgeon Inclusion Criteria:

  • Non-resident surgeon >18 years old
  • Cares for women >/= 70 years at one of the recruitment practices.
  • Ability and willingness to provide verbal consent

Aim 1 Participant Inclusion Criteria: Participants whose medical records will be followed for treatments received and survival

  • 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.

Aim 1 Participant Inclusion Criteria: Participants whose medical records will be reviewed retrospectively for treatments received in the year before the participating surgeon completes the baseline questionnaire

  • Biological female
  • aged 70 or older
  • a first primary invasive breast cancer
  • clinically </=2 cm
  • clinically lymph node negative
  • estrogen receptor positive(ER+) -HER2-
  • saw a participating surgeon for an initial encounter in the year before the surgeon completed the baseline questionnaire.

Aim 2 Participant Inclusion Criteria: Participants who will be included in Aim 2 participant surveys to learn patient reported outcomes

  • 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. If a patient completes the baseline questionnaire and then is found to have different tumor characteristics (e.g., found to be lymph node positive during surgery), investigators plan to retain the patient in the study and ask them to complete the second survey.

Primary caregiver Inclusion Criteria:

  • primary family, friend, or non-paid caregiver (herein referred to as caregiver) of a patient unable or unwilling to complete study questionnaires due to cognitive decline. The primary family, friend, or non-paid caregiver will be identified by the patient, self-identified, or documented as the decision maker in the medical record.
  • Age >18
  • English or Spanish speaking
  • Ability and willingness to provide verbal consent

Allied health professionals (Aim 4 at the end of the trial) Inclusion Criteria:

  • Administrator, social worker, physician assistant, navigator, nurse or other allied health professional in breast surgery
  • Ability and willingness to provide verbal consent

Surgeon Exclusion Criteria:

  • Resident surgeon
  • Non-surgeons
  • Psychiatric illness situations that would limit compliance with study requirements

Aim 1 Participant Exclusion criteria: Participants whose medical records will be followed for treatments received and survival

  • 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

Aim 1 Participant Exclusion Criteria: Participants whose medical records will be reviewed retrospectively for treatments received in the year before the participating surgeon completes the baseline questionnaire

  • 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. If the DA is found to be effective in English and Spanish we plan to have the DA professionally translated to other languages at the end of the trial. English and Spanish are the most common languages spoken by older women at our recruitment sites.
  • History of invasive breast cancer
  • History ductal carcinoma in situ treated with radiation (since these women are generally not be eligible for radiation treatment)
  • Paget's disease inflammatory breast cancer
  • Phyllodes tumor
  • In hospice
  • Surgeon not willing to participate

Aim 2 Participant Exclusion Criteria: Participants who will be included in Aim 2 participant surveys to learn patient reported outcomes

  • Age <70
  • Biological males: Biological males will be excluded since the data informing our 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
  • Women with history ductal carcinoma in situ treated with radiation (since these women are generally not be eligible for radiation treatment)
  • Paget's disease
  • Inflammatory breast cancer
  • A phyllodes tumor.
  • In hospice
  • Surgeon not willing to participate
  • Psychiatric illness situations that would limit compliance with study requirements
  • History of dementia
  • Incapacity for informed consent
  • Surgeon not willing to have patient complete study surveys
  • 19 patients already successfully recruited that month and the patient is non-Hispanic white.

Primary Caregiver Exclusion Criteria:

  • Age <18
  • Non-English and non-Spanish speaking
  • Psychiatric illness situations that would limit compliance with study requirements

Allied health professionals (Aim 4 at the end of the trial) Exclusion Criteria:

  • A trainee
  • Psychiatric illness situations that would limit compliance with study requirements

Study Design

Enrollment

402 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

  • Receipt of aggressive treatment within 6 months of First Surgical Encounter (Arm A) [ Time Frame: 6 months ]
  • Participant Perceived Shared Decision Making Quality Scale Score (Arm D) [ Time Frame: at 1 week ]
  • Participant Perceived Shared Decision Making Quality Scale Score (Arm A) [ Time Frame: at 1 week ]
  • Receipt of aggressive treatment within 6 months of First Surgical Encounter (Arm D) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Principal Investigator:

Mara Schonberg, MD

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Principal Investigator:

Ko Un Park, MD

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Apr 7, 2026

Last verified

Feb, 2026

Keywords

  • Breast Neoplasm
  • Breast Neoplasms
  • Breast Cancer
  • ER+ Breast Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-04-07.