Decisional Aid Intervention for Women Considering Breast Reconstruction

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT01951534

Run by

Rutgers, The State University of New Jersey

People needed

56

Starts

2011-01-01

Expected to finish

2016-06-07

Last updated by the study team

2017-01-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patient who selects lumpectomy and not mastectomy

Where it is running

• Ocean Medical Center — Brick, New Jersey, United States
• Cooper Hospital/University Medical Center — Camden, New Jersey, United States
• Bayshore Community Hospital — Holmdel, New Jersey, United States
• Southern Ocean Medical Center — Manahawkin, New Jersey, United States
• Jersey Shore University Medical Center — Neptune City, New Jersey, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• Riverview Medical Center — Red Bank, New Jersey, United States
• Somerset Medical Center — Somerville, New Jersey, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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