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NCT03428399 · ClinicalTrials.gov registry record
Depression and Body Image Distress Following Mastectomy With Reconstruction
A clinical trial, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- 51
- Enrollment target
NCT03428399: Completed study, sponsored by Massachusetts General Hospital.
NCT03428399 is a clinical trial that has completed, run by Massachusetts General Hospital. The registered enrollment target is 51 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03428399 has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- 51 participants
- Enrollment target
Study Summary
Mastectomy is a major surgery that can have a profound effect on women's psychosocial wellbeing, including elevated depression and body image distress. Reconstructive breast surgery aims to improve patients' psychosocial adjustment to mastectomy, yet for some women substantial distress persists after reconstruction. However, very little is known about risk or protective factors for persistent depression or body image distress following mastectomy with reconstruction. The present study aims to address this critical gap. In women undergoing mastectomy with breast reconstruction, the investigators will assess risk and protective factors for post-surgery depression severity and body image distress.
Primary Outcome
Assesses severity of body image distress related to breast cancer treatment with a summed total score, which ranges from 0 (no body image distress) to 30 (substantial body image distress).
Interventions
- OTHER Psychosocial variables
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2017-10-12 |
| Est. Completion | 2021-05-03 |
What the finished NCT03428399 record still lists
NCT03428399 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 51 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Psychosocial variables is the first listed.
NCT03428399 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03428399 about?
NCT03428399 is a clinical study titled "Depression and Body Image Distress Following Mastectomy With Reconstruction". Mastectomy is a major surgery that can have a profound effect on women's psychosocial wellbeing, including elevated depression and body image distress. Reconstructive breast surgery aims to improve patients' psychosocial adjustment to mastectomy, yet for some women substantial distress persists afte...
What is the current status of trial NCT03428399?
This trial is currently completed. The enrollment target is 51 participants. The study started on 2017-10-12. Estimated completion is 2021-05-03.
What interventions are being tested in trial NCT03428399?
The interventions under investigation include: Psychosocial variables (OTHER).
Who is sponsoring clinical trial NCT03428399?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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