Decisional Aid Intervention for Women Considering Breast Reconstruction
Status: | Active, not recruiting |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | January 2011 |
End Date: | January 2017 |
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.
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.
Inclusion Criteria:
- Patient is scheduled for a surgical consult with a breast surgeon
- Primary diagnosis of Stage 0 (Ductal Carcinoma in situ), 1, 2, or 3a breast cancer
- Patient speaks and reads English
- Patient is considering mastectomy
Exclusion Criteria:
- Patient who selects lumpectomy and not mastectomy
We found this trial at
9
sites
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