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New tool aims to help older women avoid unnecessary breast cancer surgery

NCT ID NCT06896474

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 402 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Sep 2033

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    11 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Beckman Research Institute of the City of Hope

    NOT_YET_RECRUITING

    Los Angeles, California, 91010, United States

  • Beth Israel Deaconess Hospital

    NOT_YET_RECRUITING

    Needham, Massachusetts, 02492, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Dana Farber Cancer Institute

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02215, United States

  • Dana-Farber/Brigham and Women's Cancer Center at South Shore Hospital

    NOT_YET_RECRUITING

    Weymouth, Massachusetts, 02198, United States

  • Duke University

    NOT_YET_RECRUITING

    Durham, North Carolina, 27705, United States

  • Lahey Hospital and Medical Center

    NOT_YET_RECRUITING

    Burlington, Massachusetts, 01805, United States

  • Rutgers State University of New Jersey Medical School

    NOT_YET_RECRUITING

    Newark, New Jersey, 07103, United States

  • University of New Mexico

    NOT_YET_RECRUITING

    Albuquerque, New Mexico, 87131, United States

  • University of Rochester

    NOT_YET_RECRUITING

    Rochester, New York, 14642, United States

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