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Spots Global Cancer Trial Database for Decisional Aid Intervention for Women Considering Breast Reconstruction

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Decisional Aid Intervention for Women Considering Breast Reconstruction

Official Title: Decisional Aid Intervention for Women Considering Breast Reconstruction

Study ID: NCT01951534

Conditions

Breast Cancer

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Sharon Manne, PhD

Affiliation: Rutgers Cancer Institute of New Jersey

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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