Decisional Aid Intervention for Women Considering Breast Reconstruction
BRDA
2 other identifiers
interventional
56
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Jan 2011
Longer than P75 for not_applicable breast-cancer
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 7, 2013
CompletedFirst Posted
Study publicly available on registry
September 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2016
CompletedJanuary 24, 2017
January 1, 2017
4.5 years
May 7, 2013
January 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Acceptability of BRDA
3 years
Impact of breast reconstruction decisional aid on knowledge and attitudes
3 years
Study Arms (2)
Breast Reconstruction Decisional Aid (BRDA)
EXPERIMENTALIn 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.
Usual Care (UC)
OTHERIn 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patient who selects lumpectomy and not mastectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rutgers, The State University of New Jerseylead
- National Cancer Institute (NCI)collaborator
- Rutgers Cancer Institute of New Jerseycollaborator
Study Sites (9)
Ocean Medical Center
Brick, New Jersey, 08742, United States
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103, United States
Bayshore Community Hospital
Holmdel, New Jersey, 07733, United States
Southern Ocean Medical Center
Manahawkin, New Jersey, 08050, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07754, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Riverview Medical Center
Red Bank, New Jersey, 07701, United States
Somerset Medical Center
Somerville, New Jersey, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sharon Manne, PhD
Rutgers Cancer Institute of New Jersey
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2013
First Posted
September 26, 2013
Study Start
January 1, 2011
Primary Completion
June 30, 2015
Study Completion
June 7, 2016
Last Updated
January 24, 2017
Record last verified: 2017-01