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

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Non-resident surgeon \>18 years old

• Cares for women \>/= 70 years at one of the recruitment practices.

• Ability and willingness to provide verbal consent

• 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.

• 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.

• 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 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

• Administrator, social worker, physician assistant, navigator, nurse or other allied health professional in breast surgery

• Ability and willingness to provide verbal consent

Locations
United States
California
Beckman Research Institute of the City of Hope
NOT_YET_RECRUITING
Los Angeles
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Brigham and Women's Hospital
RECRUITING
Boston
Dana Farber Cancer Institute
NOT_YET_RECRUITING
Boston
Lahey Hospital and Medical Center
NOT_YET_RECRUITING
Burlington
Beth Israel Deaconess Hospital
NOT_YET_RECRUITING
Needham
Dana-Farber/Brigham and Women's Cancer Center at South Shore Hospital
NOT_YET_RECRUITING
Weymouth
North Carolina
Duke University
NOT_YET_RECRUITING
Durham
New Jersey
Rutgers State University of New Jersey Medical School
NOT_YET_RECRUITING
Newark
New Mexico
University of New Mexico
NOT_YET_RECRUITING
Albuquerque
New York
University of Rochester
NOT_YET_RECRUITING
Rochester
Contact Information
Primary
Mara Schonberg, MD
mschonbe@bidmc.harvard.edu
617-754-1414
Time Frame
Start Date: 2026-02-04
Estimated Completion Date: 2033-09-30
Participants
Target number of participants: 402
Treatments
Experimental: Surgeons + SDM/DA
22 enrolled surgeon participants will be randomized and will complete:~* Baseline questionnaire~* Virtual 1 hour training on SDM~* 3-month training follow up survey~* At Month 12: 6 surgeon participants will take part in a semi-structured interview with research assistant/PI by phone, in-person, or virtually~* End-of-study survey~* At end of study 6 surgeon participants will take part in a semi-structured interview with research assistant/PI by phone, in-person, or virtually.~Approximately, 153 patients and 17 caregivers will be in this arm. They will complete a survey at 1 week and 6 months. At 12 months investigators will ask 12 patients and 4 caregivers to complete a qualitative interview. At end of study investigators will ask 12 patients and 4 caregivers to complete a qualitative semi-structured interview with research assistant/PI by phone, in-person, or virtually.
No_intervention: Standard-of-Care
22 enrolled surgeons will be randomized to usual care and will complete:~* Baseline questionnaire~* End-of-study survey~* May choose to participat in End-of-study virtual 1 hour training on SDM~* 3-month training follow up survey evaluating the training~Approximately, 153 patients and 17 care-givers will be in this arm. They will complete a survey at 1 week and 6 months.
Related Therapeutic Areas
Sponsors
Leads: Beth Israel Deaconess Medical Center

This content was sourced from clinicaltrials.gov