Status:
ACTIVE_NOT_RECRUITING
Increasing Patients' Engagement in Breast Cancer Surgery Decision-Making
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Agency for Healthcare Research and Quality (AHRQ)
Conditions:
Breast Cancer Stage 0
Breast Cancer Stage I
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This trial studies how well a breast cancer surgery decision aid works in increasing patient engagement in decision making for patients with newly diagnosed stage 0-III breast cancer. The trial also e...
Detailed Description
The primary and secondary objectives of the study: PRIMARY OBJECTIVES: I. Test the effectiveness of a breast cancer surgery decision aid in increasing patient engagement in decision making (measured...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Newly diagnosed with stage 0-III breast cancer
- Eligible patients must be planning breast surgery as a component of their definitive treatment
- Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study
- Patients with hearing impairment requiring the use of an interpreter are not eligible for this study
- Patients must be able to speak English with the fluency required to have a direct discussion around treatment decision-making (i.e. without interpreter)
- CLINIC STAKEHOLDER (SURGEONS AND CLINIC STAFF): Breast surgeon(s) and nursing staff, medical assistant, or mid-level provider at each participating clinic who participates in the care of patients newly diagnosed with breast cancer
- INSTITUTIONAL: 10 clinics that annually provide surgical care for 120-300 patients newly diagnosed with breast cancer will be selected to participate in this study
- INSTITUTIONAL: Surgeons at eligible clinics must consent to the study as a requirement for site participation
Exclusion
Key Trial Info
Start Date :
June 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2026
Estimated Enrollment :
627 Patients enrolled
Trial Details
Trial ID
NCT03766009
Start Date
June 5 2019
End Date
December 15 2026
Last Update
January 28 2025
Active Locations (58)
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1
Epic Care-Dublin
Dublin, California, United States, 94568
2
Bay Area Breast Surgeons Inc
Emeryville, California, United States, 94608
3
Epic Care Partners in Cancer Care
Emeryville, California, United States, 94608
4
Contra Costa Regional Medical Center
Martinez, California, United States, 94553-3156