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Brief Title: Decisional Aid Intervention for Women Considering Breast Reconstruction
Official Title: Decisional Aid Intervention for Women Considering Breast Reconstruction
Study ID: NCT01951534
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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, 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
Name: Sharon Manne, PhD
Affiliation: Rutgers Cancer Institute of New Jersey
Role: PRINCIPAL_INVESTIGATOR