Helping women 70+ with small, ER+ breast cancers choose the right treatment
SDM POSSIBLE: A Cluster RCT of a Breast Cancer Treatment Decision Aid for Women 70+ With Low-Risk Stage I Breast Cancers
This trial will test whether training surgeons in shared decision making and sending women 70 and older a decision aid before their first surgical visit helps them make better-informed treatment choices for small, ER+, HER2- stage I breast cancers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 402 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 11 sites (Los Angeles, California and 10 other locations) |
| Trial ID | NCT06896474 on ClinicalTrials.gov |
What this trial studies
This is a surgeon-level, cluster-randomized trial testing a multi-level intervention that combines a one-hour shared decision-making training for breast surgeons with a patient decision aid mailed or sent via patient portal/email before the first surgical visit. Participating surgeons (target n=44) at multiple large U.S. health systems are randomized to deliver the intervention or to continue usual care, and outcomes will be tracked using medical record review for treatments received and survival. The decision aid provides clear, comprehensive information about benefits and harms of treatment options and how those options interact with a patient's health, life expectancy, values, and preferences. The trial focuses on biological females aged 70 or older with a first primary invasive breast cancer ≤2 cm, node negative, ER+, HER2- disease scheduled with a participating surgeon.
Who should consider this trial
Good fit: Ideal candidates are biological females aged 70 or older with a first primary invasive breast cancer clinically ≤2 cm, node negative, ER+, HER2-, who are scheduled for an initial surgical consultation with a participating surgeon.
Not a fit: Patients with tumors larger than 2 cm, node-positive or metastatic disease, non-ER+/HER2+ cancers, prior breast cancers, significant cognitive impairment, or those not seen by participating surgeons/sites are unlikely to benefit from this specific intervention.
Why it matters
Potential benefit: If successful, the intervention could help older women make higher-quality treatment decisions that better match their values and may reduce unnecessary or burdensome therapies.
How similar studies have performed: Decision aids and clinician shared decision-making training have improved decision quality in other clinical settings, but applying this combined approach specifically for women 70+ with low-risk ER+ stage I breast cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California and 10 other locations
- Beckman Research Institute of the City of Hope — Los Angeles, California, United States (Not_yet_recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Not_yet_recruiting)
- Lahey Hospital and Medical Center — Burlington, Massachusetts, United States (Not_yet_recruiting)
- Beth Israel Deaconess Hospital — Needham, Massachusetts, United States (Not_yet_recruiting)
- Dana-Farber/Brigham and Women's Cancer Center at South Shore Hospital — Weymouth, Massachusetts, United States (Not_yet_recruiting)
- Rutgers State University of New Jersey Medical School — Newark, New Jersey, United States (Not_yet_recruiting)
- University of New Mexico — Albuquerque, New Mexico, United States (Not_yet_recruiting)
- University of Rochester — Rochester, New York, United States (Not_yet_recruiting)
- Duke University — Durham, North Carolina, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Mara Schonberg, MD — Beth Israel Deaconess Medical Center
- Study coordinator: Mara Schonberg, MD
- Email: mschonbe@bidmc.harvard.edu
- Phone: 617-754-1414
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.