Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04491591 · ClinicalTrials.gov registry record · NA
Implementing BREASTChoice Into Practice
A NA study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 396
- Enrollment target
NCT04491591: Completed NA study, sponsored by Washington University School of Medicine.
NCT04491591 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 396 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04491591, a NA study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 396 participants
- Enrollment target
Study 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 complications exceeds that of most elective procedures. In past work, a clinical decision support tool, BREASTChoice, with personalized risk information and patient preferences, was created to be used to address these issues. It was modified with extensive stakeholder input and built to be incorporated into electronic health records and patient portals. This randomized control trial will evaluate whether the implementation of BREASTChoice into routine care delivery is more effective than a control website, at improving the quality of reconstruction decisions.
Primary Outcome
-The validated Breast Reconstruction Decision Quality Instrument (DQI) knowledge scale contains 9 items on key facts about reconstruction. A value of 1 is given for each correct answer and a value of 0 is given for each incorrect answer. An overall knowledge score is calculated for each patient by dividing the number of correct responses (range 0-9) by 9 to be re-scaled from 0-100. Higher values indicate higher knowledge.
Interventions
- OTHER Breast Reconstruction Education and Support Tool (BREASTChoice)
- OTHER Attention Control Website
- OTHER Clinician Survey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 396 participants |
| Start Date | 2020-11-04 |
| Est. Completion | 2023-02-28 |
| Phase | NA |
What the finished NCT04491591 record still lists
NCT04491591 is an interventional study that assigns participants to a tested intervention. The registered 396 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 3 interventions - of which Breast Reconstruction Education and Support Tool (BREASTChoice) is the first listed.
NCT04491591 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04491591 about?
NCT04491591 is a clinical study titled "Implementing BREASTChoice Into Practice". 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 complications exceeds that of most elective procedures. In past work, a clinical decision support tool, BREASTCh...
What is the current status of trial NCT04491591?
This trial is currently completed. It is a NA study. The enrollment target is 396 participants. The study started on 2020-11-04. Estimated completion is 2023-02-28.
What interventions are being tested in trial NCT04491591?
The interventions under investigation include: Breast Reconstruction Education and Support Tool (BREASTChoice) (OTHER), Attention Control Website (OTHER), Clinician Survey (OTHER).
Who is sponsoring clinical trial NCT04491591?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04491591's enrollment target sits among peer trials
396 268th of 2000 higher than 1,733 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05633615 · 396 participants · Phase 2
Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
- NCT06227910 · 396 participants · Phase 3
A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
- NCT06545331 · 396 participants · Phase 1
Study of XB010 in Subjects With Solid Tumors
- NCT06666790 · 396 participants · NA
DermaSensor Postmarket Surveillance Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI