RecruitingNot ApplicableNCT06896474
SDM POSSIBLE: A Breast Cancer Treatment Decision Aid for Women 70+ With Low-Risk Stage I Breast Cancers
SDM POSSIBLE: A Cluster RCT of a Breast Cancer Treatment Decision Aid for Women 70+ With Low-Risk Stage I Breast Cancers
Sponsor
Beth Israel Deaconess Medical Center
Enrollment
402 participants
Start Date
Feb 4, 2026
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 120 Years
Inclusion Criteria30
- 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
- estrogen receptor positive(ER+) -HER2-
- saw a participating surgeon for an initial encounter in the year before the surgeon completed the baseline questionnaire.
- 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 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
- Administrator, social worker, physician assistant, navigator, nurse or other allied health professional in breast surgery
- Ability and willingness to provide verbal consent
Exclusion Criteria42
- 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.
- 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
- 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
- patients already successfully recruited that month and the patient is non-Hispanic white.
- Age \<18
- Non-English and non-Spanish speaking
- Psychiatric illness situations that would limit compliance with study requirements
- A trainee
- Psychiatric illness situations that would limit compliance with study requirements
Interventions
BEHAVIORALShared 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.
Locations(11)
View Full Details on ClinicalTrials.gov
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NCT06896474
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