Breast Cancer
Conditions
Keywords
breast reconstruction
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.
Interventions
BEHAVIORALBreast Reconstruction Decisional Aid (BRDA)
BEHAVIORALUsual Care
Sponsors
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of a decisional aid to assist women with making the decision to undergo breast reconstruction | 3 years | 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
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of BRDA | 3 years | 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 | 3 years | 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. |
Countries
United States
Outcome results
None listed