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

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Mar 24, 2025

Keywords

ClinConnect Summary

The SDM POSSIBLE trial is studying a new way to help women aged 70 and older make informed decisions about their treatment for low-risk stage I breast cancer. The goal is to provide doctors with special training and patients with helpful resources, like a decision-making guide, which can help them discuss treatment options together. This study will take place at six large health systems across four regions, and researchers hope that by improving communication between doctors and patients, they can lead to better treatment choices and health outcomes.

To be eligible for this trial, participants must be biological females aged 70 or older who are diagnosed with a first primary invasive breast cancer that is small (2 cm or less) and has no lymph nodes involved. Participants will receive information through mail or online before their first visit with a surgeon. Family members or caregivers can also participate if the patient needs help completing questionnaires. Overall, the trial aims to enhance the decision-making process for older women facing breast cancer treatment, making it easier for them to understand their options and feel confident in their choices.

Gender

FEMALE

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