Status:
COMPLETED
Implementing BREASTChoice Into Practice
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Agency for Healthcare Research and Quality (AHRQ)
Conditions:
Breast Reconstruction
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Breast reconstruction after mastectomy is a highly personal decision. Although it can restore quality of life for many, there are numerous risks associated with the procedure. The risk of complication...
Detailed Description
Prior to the beginning of the Randomized Control Trial (RCT), a pilot phase will be launched to test the workflow and procedures. The investigators plan to recruit up to 20 patients, continuing until ...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Diagnosis of incident or recurrent stage 0-III breast carcinoma
Exclusion
- Stage IV breast carcinoma
- Histology type besides ductal/lobular carcinoma (e.g. phyllodes, sarcoma - these rare tumors differ in treatment and prognosis)
- Prior mastectomy and are seeking delayed breast reconstruction
- No malignancy (i.e., considering mastectomy for prophylaxis only)
- Cannot give informed consent or use provided study materials due to self-reported or observed cognitive, visual, or emotional barriers
- Inclusion Criteria for Clinicians:
- Clinicians who provide breast cancer care within the plastic and reconstructive surgery at Barnes Jewish Hospital, Siteman Cancer Center, Barnes Jewish West County, Christian Hospital North East, and the Stefanie Spielman Comprehensive Breast Center of OSU who provide care for patients considering breast reconstruction after mastectomy
- Exclusion Criteria for Clinicians:
- Plastic and reconstructive clinicians working at other breast clinic locations, and surgeons who do provider breast reconstruction care to patients who have undergone a mastectomy due to breast cancer
Key Trial Info
Start Date :
November 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2023
Estimated Enrollment :
396 Patients enrolled
Trial Details
Trial ID
NCT04491591
Start Date
November 4 2020
End Date
February 28 2023
Last Update
August 12 2024
Active Locations (2)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
2
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210