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NCT03346161 · ClinicalTrials.gov registry record · Phase 1
Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
NCT03346161: Completed Phase 1 study, sponsored by Washington University School of Medicine.
NCT03346161 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 120 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03346161, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
Study Summary
Although clinical decision tools (CDTs) exist for a variety of treatments, CDTs designed to support personalized breast reconstruction decisions, particularly about type and timing of reconstruction, are lacking. The objective of this proposal is to develop and pilot test a clinical decision tool that provides personalized risk information and reflects patients' preferences and clinical needs.
Primary Outcome
To determine whether the CDT increases knowledge about their choice, the investigators will compare objective knowledge scores between participants using the CDT and those who received usual care
Interventions
- OTHER Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction"
- OTHER Decision tool
- OTHER Usual Care Group - Outcome Measures
- OTHER Decision Group - Outcome Measures
- OTHER Demographic and Background Questions
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2018-01-09 |
| Est. Completion | 2018-10-24 |
| Phase | Phase 1 |
What the finished NCT03346161 record still lists
NCT03346161 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher).
The record links to 0 conditions, and to 5 interventions - of which Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction" is the first listed.
NCT03346161 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03346161 about?
NCT03346161 is a clinical study titled "Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach". Although clinical decision tools (CDTs) exist for a variety of treatments, CDTs designed to support personalized breast reconstruction decisions, particularly about type and timing of reconstruction, are lacking. The objective of this proposal is to develop and pilot test a clinical decision tool th...
What is the current status of trial NCT03346161?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2018-01-09. Estimated completion is 2018-10-24.
What interventions are being tested in trial NCT03346161?
The interventions under investigation include: Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction" (OTHER), Decision tool (OTHER), Usual Care Group - Outcome Measures (OTHER), Decision Group - Outcome Measures (OTHER), Demographic and Background Questions (OTHER).
Who is sponsoring clinical trial NCT03346161?
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 NCT03346161's enrollment target sits among peer trials
120 479th of 2000 higher than 1,503 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
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