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NCT04817709 · ClinicalTrials.gov registry record
Development of a Patient Decision Aid for Women Considering Breast Reconstruction
A clinical trial, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- 126
- Enrollment target
NCT04817709: Completed study, sponsored by M.D. Anderson Cancer Center.
NCT04817709 is a clinical trial that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 126 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04817709 has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- 126 participants
- Enrollment target
Study Summary
This study engages cancer survivors who have considered breast reconstruction after mastectomy in developing and pilot testing an up-to-date, understandable, meaningful patient decision aid video and workbook. Once the video and workbook are pilot-tested, a field test with new patients will then compare whether it is more feasible and useful for women considering breast reconstruction after mastectomy to view a video and workbook before their appointment or an educational booklet during their appointment. The video explains the process and types of reconstruction, the timeline for how breast reconstruction is done, and how the cost of this surgery is covered. The workbook helps patients compare your options and prepare for the appointment. The educational booklet explains the same process, types, timeline and costs, and is designed to help the patient and their surgeon compare and discuss the options together during the appointment. By comparing these two methods, researchers may learn which of these is more effective in helping patients make a decision about breast reconstruction.
Primary Outcome
The statistician will calculate how many women to whom the research assistant was able to deliver the video/workbook or educational materials (i.e., by sending them the URL link or scheduling time to show them the video/workbook or educational materials on an iPad at the clinic), out of the total n = 130 eligible women. The statistician will also calculate the rates of women who prefer to view the video and workbook at home or at the clinic; and of women who re-visit the video and workbook after
Interventions
- OTHER Questionnaire Administration
- OTHER Medical Chart Review
- OTHER Usual Care
- OTHER Educational Intervention
- OTHER Media Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2017-03-20 |
| Est. Completion | 2021-05-20 |
What the finished NCT04817709 record still lists
NCT04817709 is an observational study that tracks outcomes without assigning an intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 5 interventions - of which Questionnaire Administration is the first listed.
NCT04817709 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04817709 about?
NCT04817709 is a clinical study titled "Development of a Patient Decision Aid for Women Considering Breast Reconstruction". This study engages cancer survivors who have considered breast reconstruction after mastectomy in developing and pilot testing an up-to-date, understandable, meaningful patient decision aid video and workbook. Once the video and workbook are pilot-tested, a field test with new patients will then com...
What is the current status of trial NCT04817709?
This trial is currently completed. The enrollment target is 126 participants. The study started on 2017-03-20. Estimated completion is 2021-05-20.
What interventions are being tested in trial NCT04817709?
The interventions under investigation include: Questionnaire Administration (OTHER), Medical Chart Review (OTHER), Usual Care (OTHER), Educational Intervention (OTHER), Media Intervention (OTHER).
Who is sponsoring clinical trial NCT04817709?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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