SDM POSSIBLE: A Breast Cancer Treatment Decision Aid for Women 70+ With Low-Risk Stage I Breast Cancers (NCT06896474)
SDM POSSIBLE: A Cluster RCT of a Breast Cancer Treatment Decision Aid for Women 70+ With Low-Risk Stage I Breast Cancers
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Beckman Research Institute of the City of Hope โ Los Angeles, California
Age range: 18 Years
๐งช Interventions in This Study
- Shared Decision-Making Training and Decision Aid (BEHAVIORAL)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (11 Sites)
- Beckman Research Institute of the City of Hope โ Los Angeles, California
- Beth Israel Deaconess Medical Center โ Boston, Massachusetts
- Brigham and Women's Hospital โ Boston, Massachusetts
- Dana Farber Cancer Institute โ Boston, Massachusetts
- Lahey Hospital and Medical Center โ Burlington, Massachusetts
- Beth Israel Deaconess Hospital โ Needham, Massachusetts
- Dana-Farber/Brigham and Women's Cancer Center at South Shore Hospital โ Weymouth, Massachusetts
- Rutgers State University of New Jersey Medical School โ Newark, New Jersey
- University of New Mexico โ Albuquerque, New Mexico
- University of Rochester โ Rochester, New York
- Duke University โ Durham, North Carolina
๐ Contact the Study Coordinator
Phone: (617) 754-1414
Email: mschonbe@bidmc.harvard.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.