NCT06896474 SDM POSSIBLE: A Breast Cancer Treatment Decision Aid for Women 70+ With Low-Risk Stage I Breast Cancers

Eligibility & Interventions

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What to Expect as a Participant

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This trial targets 402 participants in total. It began in 2026-02-04 with a primary completion date of 2032-10-01.

Brief 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 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

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