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SDM POSSIBLE: Breast Cancer Treatment Decision Aid for Women 70+

This study, called SDM POSSIBLE, is testing a new approach to help women aged 70 and older with early-stage breast cancer make treatment decisions. The study will train surgeons in shared decision-making techniques and provide eligible patients with a special breast cancer treatment decision aid before their first surgery consultation. This decision aid offers detailed information about different treatment options, including their benefits and risks, and considers how these choices might affect your health, life expectancy, and personal preferences. The goal is to see if this new approach leads to better quality treatment decisions and improved care. To be eligible, you must be a biological female, 70 or older, with a first primary invasive breast cancer that is estrogen receptor positive (ER+) and HER2 negative (HER2-). The study will measure success by looking at whether patients receive aggressive treatment within six months and by assessing the quality of shared decision-making.

Study design
This is an interventional study that plans to enroll 402 participants. It is a randomized trial where some surgeons and their patients will receive the new decision-making tools, and others will receive usual care.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your treatment will be followed for six months, and your perception of shared decision-making quality will be measured at one week.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06896474

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

Recruiting
NAAges 18+InterventionalHealth services
Beth Israel Deaconess Medical Center
~402 participants
Updated 2026-04-07 on ClinicalTrials.gov
What's tested:Shared Decision-Making Training and Decision Aid

At a glance

Recruiting sites
2 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Receipt of aggressive treatment within 6 months of First Surgical Encounter (Arm A)
Measured over 6 months
+3 more outcomes measured

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

11 sites across 6 states
Massachusetts6
California1
New Jersey1
New Mexico1
New York1
North Carolina1

Study leadership

  • Mara Schonberg, MD · PRINCIPAL_INVESTIGATOR · Beth Israel Deaconess Medical Center

Who to contact

Mara Schonberg, MD
[email protected]
617-754-1414
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
19 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

What this trial measures

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

    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.

  • Participant Perceived Shared Decision Making Quality Scale Score (Arm D)at 1 week

    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.

  • Participant Perceived Shared Decision Making Quality Scale Score (Arm A)at 1 week

    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.

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

    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.