SDM POSSIBLE: A Cluster RCT of a Breast Cancer Treatment Decision Aid for Women 70+ With Low-Risk Stage I Breast Cancers
Beth Israel Deaconess Medical Center
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.
Description
In a parallel group-randomized trial, investigators aim to test the effects of training breast surgeons in shared decision making and providing their female patients aged 70 and older with Stage 1 (2 centimeters or less), estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer a patient decision aid on breast cancer treatment. The decision aid is novel in that it includes comprehensive information about the benefits and harms of the different breast cancer treatments that older woman may be offered. It also highlights the complex interplay betw…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 in…
Interventions
- BehavioralShared Decision-Making Training and Decision Aid
The intervention includes training surgeons in shared decision making techniques and providing eligible participants with a tailored breast cancer treatment decision aid prior to the initial surgical consultation.
Locations (11)
- Beckman Research Institute of the City of HopeLos Angeles, California
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Brigham and Women's HospitalBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts
- Lahey Hospital and Medical CenterBurlington, Massachusetts
- Beth Israel Deaconess HospitalNeedham, Massachusetts