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New treatment option for Breast Cancer
Official title SDM POSSIBLE: A Breast Cancer Treatment Decision Aid for Women 70+ With Low-Risk Stage I Breast Cancers
ClinicalTrials.gov ID: NCT06896474
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Surgeon
- 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 Participants whose medical records will be followed for treatments received and...
- Biological female
You likely can't join if
- Resident surgeon
- Non-surgeons
- Psychiatric illness situations that would limit compliance with study requirements Aim 1 Participant Exclusion criteria: Participants whose medical...
- Age \<70
- Biological males: Biological males will be excluded since the data informing the DA were obtained from studies of biological females and treatment...
- 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.
See the full eligibility criteria
Who can join
- Surgeon
- 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 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+...
- 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 Participants who will be included in Aim 2 participant surveys to learn patient...
- 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...
- 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...
- Age \>18
- English or Spanish speaking
- Ability and willingness to provide verbal consent Allied health professionals (Aim 4 at the end of the trial)
- Administrator, social worker, physician assistant, navigator, nurse or other allied health professional in breast surgery
- Ability and willingness to provide verbal consent Surgeon
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Boston, Massachusetts, United States
- Burlington, Massachusetts, United States
- Needham, Massachusetts, United States
- Weymouth, Massachusetts, United States
- Newark, New Jersey, United States
- Albuquerque, New Mexico, United States
- Rochester, New York, United States
- Durham, North Carolina, United States
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Boston, Massachusetts, United States; Burlington, Massachusetts, United States; Needham, Massachusetts, United States; Weymouth, Massachusetts, United States; Newark, New Jersey, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.