Overview

This trial has been completed.

Condition breast cancer
Treatments breast reconstruction decisional aid (brda), usual care
Sponsor Rutgers, The State University of New Jersey
Collaborator National Cancer Institute (NCI)
Start date January 2011
End date January 2017
Trial size 50 participants
Trial identifier NCT01951534, 131025, R21CA149531-01A1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Arm
(Experimental)
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.
breast reconstruction decisional aid (brda)
(Other)
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.
usual care

Primary Outcomes

Measure
Feasibility of a decisional aid to assist women with making the decision to undergo breast reconstruction
time frame: 3 years

Secondary Outcomes

Measure
Acceptability of BRDA
time frame: 3 years
Impact of breast reconstruction decisional aid on knowledge and attitudes
time frame: 3 years

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Decisional Aid Intervention for Women Considering Breast Reconstruction
Principal investigator Sharon Manne, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey.
Location data was received from the National Cancer Institute and was last updated in November 2016.