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NCT01951534 · ClinicalTrials.gov registry record · NA
Decisional Aid Intervention for Women Considering Breast Reconstruction
A NA study, sponsored by Rutgers, The State University of New Jersey.
- Completed
- Registry status
- NA
- Development phase
- 56
- Enrollment target
NCT01951534 is a NA study that has completed, run by Rutgers, The State University of New Jersey. The registered enrollment target is 56 participants.
The verdict
NCT01951534, a NA study, has completed, sponsored by Rutgers, The State University of New Jersey.
- COMPLETED
- Registry status
- NA
- Development phase
- 56 participants
- Enrollment target
Study Summary
This is an intervention development and pilot study whose purpose is to determine the feasibility and acceptability of the breast reconstruction decisional aid (BRDA) and provide preliminary data on its impact on decisional outcomes. The primary aim of this study is: "Is the intervention trial feasible?" The purpose is to develop a feasible web-based decisional aid (DA) for a larger scale trial. Thus it is important that this trial provide evidence of feasibility. The investigators will define feasibility as the rate of study acceptance and participation. The secondary aim of this study is: " Is the BRDA acceptable and used?" The team will evaluate BRDA acceptability, use, difficulty with internet use, and what factors predict uptake and use. The investigators anticipate that, due to interest in the topic, the majority of women will access the website. An additional secondary aim of this study is: "What is the impact of BRDA on BR knowledge, attitudes about BR, decisional conflict, preparedness and completeness of preparation, anxiety, and discussion with oncologist?" The purpose is to calculate effect sizes for a larger randomized trial.
Interventions
- BEHAVIORAL Usual Care
- BEHAVIORAL Breast Reconstruction Decisional Aid (BRDA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2011-01 |
| Est. Completion | 2016-06-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01951534
The ClinicalTrials.gov registry entry for NCT01951534 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rutgers, The State University of New Jersey, which has 413 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Usual Care is the first listed.
NCT01951534 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01951534 about?
NCT01951534 is a clinical study titled "Decisional Aid Intervention for Women Considering Breast Reconstruction". This is an intervention development and pilot study whose purpose is to determine the feasibility and acceptability of the breast reconstruction decisional aid (BRDA) and provide preliminary data on its impact on decisional outcomes. The primary aim of this study is: "Is the intervention trial feas...
What is the current status of trial NCT01951534?
This trial is currently completed. It is a NA study. The enrollment target is 56 participants. The study started on 2011-01. Estimated completion is 2016-06-07.
What interventions are being tested in trial NCT01951534?
The interventions under investigation include: Usual Care (BEHAVIORAL), Breast Reconstruction Decisional Aid (BRDA) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01951534?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
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