Clinical trial NCT01951534: Decisional Aid Intervention for Women Considering Breast Reconstruction
Official title: Decisional Aid Intervention for Women Considering Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast reconstruction
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Rutgers Cancer Institute of New Jersey
First posted: 2013-09-26
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Feasibility of a decisional aid to assist women with making the decision to undergo breast reconstruction
timeFrame: 3 years
Secondary outcomes:
measure: Acceptability of BRDA
timeFrame: 3 years
measure: Impact of breast reconstruction decisional aid on knowledge and attitudes
timeFrame: 3 years
Other outcomes:
Locations:
city: Brick
country: United States
facility: Ocean Medical Center
state: New Jersey
city: Camden
country: United States
facility: Cooper Hospital/University Medical Center
state: New Jersey
city: Holmdel
country: United States
facility: Bayshore Community Hospital
state: New Jersey
city: Manahawkin
country: United States
facility: Southern Ocean Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Red Bank
country: United States
facility: Riverview Medical Center
state: New Jersey
city: Somerville
country: United States
facility: Somerset Medical Center
state: New Jersey
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Sharon Manne, PhD
role: PRINCIPAL_INVESTIGATOR
References: