Decisional Aid Intervention for Women Considering Breast Reconstruction (BRDA)

Rutgers The State University of New Jersey

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Usual Care; Behavioral: Breast Reconstruction Decisional Aid (BRDA)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01951534

131025

R21CA149531-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Breast Reconstruction Decisional Aid (BRDA)

Experimental group

Description:

In the BRDA arm, participants will be provided with a website address for using the Breast Reconstruction Decisional Aid, a secure password, and instructions for using the website for the decisional aid.

Treatment:

Behavioral: Breast Reconstruction Decisional Aid (BRDA)

Usual Care (UC)

Other group

Description:

In the UC Condition, the participant will not be given the web-based decisional aid but will be given the Cancer Support Community pamphlet. This 56-page pamphlet contains information about the types of Breast Reconstruction, lists reasons why women choose reconstruction, key factors to considering when deciding, how to plan for surgery, possible risks, and a glossary of terms. The pamphlet is primarily informational. It is not customized, not interactive.

Treatment:

Behavioral: Usual Care