New tool aims to help older women avoid unnecessary breast cancer surgery
NCT ID NCT06896474
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a decision aid and training for surgeons can help women aged 70 and older with low-risk stage I breast cancer make better treatment choices. About 402 participants will be split into two groups: one where surgeons get shared decision-making training and patients receive a decision aid before their first visit, and another with usual care. The goal is to see if the intervention reduces aggressive treatments like mastectomy or radiation, while improving how informed patients feel about their options.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- shared decision-making training and decision aid
- What this could lead to
- If successful, this could help older women with low-risk breast cancer make more informed, less aggressive treatment choices, improving quality of life.
- What could go wrong
- This is a behavioral study, not a drug trial, so it won't directly treat cancer. Results depend on how well surgeons and patients adopt the tools, and may not apply to all settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 402 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Sep 2033
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beckman Research Institute of the City of Hope
NOT_YET_RECRUITINGLos Angeles, California, 91010, United States
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Beth Israel Deaconess Hospital
NOT_YET_RECRUITINGNeedham, Massachusetts, 02492, United States
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Beth Israel Deaconess Medical Center
RECRUITINGBoston, Massachusetts, 02115, United States
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Brigham and Women's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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Dana Farber Cancer Institute
NOT_YET_RECRUITINGBoston, Massachusetts, 02215, United States
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Dana-Farber/Brigham and Women's Cancer Center at South Shore Hospital
NOT_YET_RECRUITINGWeymouth, Massachusetts, 02198, United States
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Duke University
NOT_YET_RECRUITINGDurham, North Carolina, 27705, United States
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Lahey Hospital and Medical Center
NOT_YET_RECRUITINGBurlington, Massachusetts, 01805, United States
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Rutgers State University of New Jersey Medical School
NOT_YET_RECRUITINGNewark, New Jersey, 07103, United States
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University of New Mexico
NOT_YET_RECRUITINGAlbuquerque, New Mexico, 87131, United States
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University of Rochester
NOT_YET_RECRUITINGRochester, New York, 14642, United States
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