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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: Completed NA study, sponsored by Rutgers, The State University of New Jersey.
NCT01951534 is a NA study that has completed, run by Rutgers, The State University of New Jersey. The registered enrollment target is 56 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
We will define feasibility as the rate of study acceptance and participation. First, we will examine acceptance as determined by consents and completed baselines. Second, we will examine time for completing surveys. We will judge this trial feasible if: 1) the acceptance rate among eligible patients is equal to or greater than 70%. We will judge completion rates at follow-up to be feasible for a larger scale trial if our completion rate is 75%. 2) If the survey length averages are \> 35 minutes,
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 |
What the finished NCT01951534 record still lists
NCT01951534 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Usual Care is the first listed.
NCT01951534 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01951534's enrollment target sits among peer trials
56 1262nd of 2000 higher than 737 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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