Decisional Aid Intervention for Women Considering Breast Reconstruction (BRDA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Rutgers, The State University of New Jersey
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01951534
First received: May 7, 2013
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: Breast Reconstruction Decisional Aid (BRDA)
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Decisional Aid Intervention for Women Considering Breast Reconstruction

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Feasibility of a decisional aid to assist women with making the decision to undergo breast reconstruction [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Acceptability of BRDA [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.

  • Impact of breast reconstruction decisional aid on knowledge and attitudes [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: January 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Breast Reconstruction Decisional Aid (BRDA)
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.
Behavioral: Breast Reconstruction Decisional Aid (BRDA)
Usual Care (UC)
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.
Behavioral: Usual Care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01951534

Contacts
Contact: Sharon L Manne, Ph.D. 732-235-6759 mannesl@cinj.rutgers.edu
Contact: Tina M Gajda, MA 732-235-6472 gajdatm@cinj.rutgers.edu

Locations
United States, New Jersey
Ocean Medical Center Recruiting
Brick, New Jersey, United States, 08742
Cooper Hospital/University Medical Center Recruiting
Camden, New Jersey, United States, 08103
Bayshore Community Hospital Recruiting
Holmdel, New Jersey, United States, 07733
Southern Ocean Medical Center Recruiting
Manahawkin, New Jersey, United States, 08050
Jersey Shore University Medical Center Recruiting
Neptune, New Jersey, United States, 07754
The Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Tina M Gajda, MA    732-235-6472    gajdatm@cinj.rutgers.edu   
Contact: Office of Human Research Services    732-235-8675      
Principal Investigator: Sharon L Manne, Ph.D.         
Riverview Medical Center Recruiting
Red Bank, New Jersey, United States, 07701
Somerset Medical Center Recruiting
Somerville, New Jersey, United States
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Sara E Frederick, MS    215-214-3794    sara.worhach@fccc.edu   
Principal Investigator: Neal Topham, MD         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Sharon Manne, PhD Rutgers Cancer Institute of New Jersey
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01951534     History of Changes
Other Study ID Numbers: 131025, R21CA149531-01A1
Study First Received: May 7, 2013
Last Updated: April 30, 2014
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by Rutgers, The State University of New Jersey:
breast reconstruction

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014