Status:
NOT_YET_RECRUITING
SDM POSSIBLE: A Breast Cancer Treatment Decision Aid for Women 70+ With Low-Risk Stage I Breast Cancers
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Breast Neoplasm
Breast Neoplasms
Eligibility:
All Genders
20+ years
Phase:
NA
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 sur...
Detailed Description
In a parallel group-randomized trial, investigators aim to test the effects of training breast surgeons in shared decision making and providing their female patients aged 70 and older with Stage 1 (2 ...
Eligibility Criteria
Inclusion
- Surgeon
- 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 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 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 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
- 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)
- Administrator, social worker, physician assistant, navigator, nurse or other allied health professional in breast surgery
- Ability and willingness to provide verbal consent
- Surgeon
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2033
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT06896474
Start Date
September 1 2025
End Date
September 30 2033
Last Update
June 26 2025
Active Locations (6)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
4
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805