Decision Aid for Breast Cancer
(SDMPOSSIBLE Trial)

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byMara Schonberg, MD

Age: 65+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Beth Israel Deaconess Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?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 6 large health systems in 4 regions 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

This trial is for women aged 70 or older who have been diagnosed with low-risk Stage I breast cancer. It's designed to help them make treatment decisions using a special decision aid and training for surgeons.

Inclusion Criteria

Administrator, social worker, physician assistant, navigator, nurse, or other allied health professional in breast surgery willing to provide verbal consent

I am a woman aged 70 or older with a small, early-stage, ER+ HER2- breast cancer.

I am a surgeon over 18, treating women 70+ at a participating practice and agree to give verbal consent.

+3 more

Exclusion Criteria

Resident surgeon, non-surgeons, or those with psychiatric illness situations that would limit compliance with study requirements

Primary caregivers under 18 years old, non-English and non-Spanish speaking individuals, or those with psychiatric illness situations that would limit compliance with study requirements

Trainees or those with psychiatric illness situations that would limit compliance with study requirements for allied health professionals in Aim 4 at the end of the trial

+2 more

Participant Groups

The study tests whether giving patients a decision aid and providing their surgeons with shared decision-making training can improve the quality of treatment decisions compared to usual care. The aids are sent through mail, patient portals, or email before the first surgery meeting.

2Treatment groups

Experimental Treatment

Active Control

Group I: Surgeons + SDM/DAExperimental Treatment1 Intervention

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.

Group II: Standard-of-CareActive Control1 Intervention

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.