Decisional Aid Intervention for Women Considering Breast Reconstruction

Breast Cancer Clinical Trial

— BRDA  

Official title:

Decisional Aid Intervention for Women Considering Breast Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01951534
• Other study ID #: 131025
• Secondary ID: R21CA149531-01A1
• Status: Completed
• Phase: N/A
• First received: May 7, 2013
• Last updated: January 20, 2017
• Start date: January 2011
• Est. completion date: June 7, 2016

Study information

• Verified date: January 2017
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 7, 2016
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Behavioral:
• Breast Reconstruction Decisional Aid (BRDA)

• Usual Care

Locations

Country	Name	City	State
United States	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	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Riverview Medical Center	Red Bank	New Jersey
United States	Somerset Medical Center	Somerville	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of a decisional aid to assist women with making the decision to undergo breast reconstruction	We will define feasibility as the rate of study acceptance and participation. First, we will examine acceptance as determined by consents and completed baselines. Second, we will examine time for completing surveys. We will judge this trial feasible if: 1) the acceptance rate among eligible patients is equal to or greater than 70%. We will judge completion rates at follow-up to be feasible for a larger scale trial if our completion rate is 75%. 2) If the survey length averages are > 35 minutes, we will deem this unacceptable and shorten the survey.	3 years
Secondary	Acceptability of BRDA	We will define acceptability using both quantitative and qualitative methods. Basic descriptive information will be automatically gathered from the DA tracking system regarding whether participants logged in, how many times, and for how long. Time spent in each module will be tracked and summarized. Participants will rate the DA and provide interview feedback regarding its ease of use. Interview feedback regarding home versus public access will be gathered. A second indicator of acceptability will be ratings on the DA evaluation and interview. The range of items on the scale is 1-7. An item mean of 4 is mid-range. We judge our intervention as acceptable if 75% of BRDA participants used the DA and if the average score on the evaluation was > 5.6, which is 80% of the highest score.	3 years
Secondary	Impact of breast reconstruction decisional aid on knowledge and attitudes	This is an exploratory objective to calculate effect sizes for a larger randomized trial. Using survey data that we will collect as part of this research, we will look at the impact of BRDA on knowledge and attitudes.	3 years