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

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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.


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
New Brunswick, New Jersey 08903
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New Brunswick, NJ
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Brick, New Jersey 08724
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Brick, NJ
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Camden, NJ
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Holmdel, New Jersey 07733
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Holmdel, NJ
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Manahawkin, New Jersey 08050
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Manahawkin, NJ
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Neptune, New Jersey 07754
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Neptune, NJ
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Philadelphia, Pennsylvania 19111
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Philadelphia, PA
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Red Bank, New Jersey 07701
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Red Bank, NJ
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Somerville, New Jersey 08876
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Somerville, NJ
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