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NCT04477538 · ClinicalTrials.gov registry record
Long Term Function Outcomes and Pain in Implant-based Post-mastectomy Breast Reconstruction
A clinical trial, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- 240
- Enrollment target
NCT04477538: Clinical Trial study, sponsored by Washington University School of Medicine.
NCT04477538 is a clinical trial that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 240 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04477538 was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- 240 participants
- Enrollment target
Study Summary
The objective of this proposal is to broadly assess patient physical functioning following breast reconstruction.
Primary Outcome
The physical well-being module is one of the domains of the BREAST-Q that can be administered in isolation. Patients answer specific questions with answers that range from 1-4 to 1-5. Upon completion of this component of the survey, a physical well-being-specific numerical score is generated. This is then converted, based on previously published Rasch-modeling to generate a Q-score whose values range from 0-100. This same approach is used for all other domains of the BREAST-Q. Pre- versus postop
Interventions
- OTHER Post-mastectomy breast reconstruction physical well-being survey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2020-07-07 |
| Est. Completion | 2021-11-08 |
Why NCT04477538 stopped before completion
NCT04477538 is an observational study that tracks outcomes without assigning an intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Post-mastectomy breast reconstruction physical well-being survey is the first listed.
NCT04477538 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04477538 about?
NCT04477538 is a clinical study titled "Long Term Function Outcomes and Pain in Implant-based Post-mastectomy Breast Reconstruction". The objective of this proposal is to broadly assess patient physical functioning following breast reconstruction.
What is the current status of trial NCT04477538?
This trial is currently terminated. The enrollment target is 240 participants. The study started on 2020-07-07. Estimated completion is 2021-11-08.
What interventions are being tested in trial NCT04477538?
The interventions under investigation include: Post-mastectomy breast reconstruction physical well-being survey (OTHER).
Who is sponsoring clinical trial NCT04477538?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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