Breast Neoplasm Female, Decision Support Techniques, Evaluation Studies, Young Adult
Conditions
Keywords
decision aid, breast cancer, young females, implementation, stepped wedge trial
Brief summary
Fertility is of great importance to young women with cancer. Concerns about the ability to become pregnant after cancer treatment may influence treatment decisions and fertility decision-making is challenging. Despite these challenges, there is a lack of fertility decision support tools. Our team developed the Begin Exploring Fertility Options, Risks and Expectations (BEFORE) decision aid for young breast cancer patients in Canada. This study aims to evaluate the implementation of the BEFORE decision aid in hospital settings through a stepped wedge cluster randomized trial.
Detailed description
The investigators will conduct a stepped wedge cluster randomized trial to sequentially implement the BEFORE decision aid in clinical settings that are currently recruiting young breast cancer patients for the Reducing the bUrden of Breast cancer in Young women (RUBY) Study (www.womensresearch.ca/ruby-study/). For this trial 24 participating RUBY sites were grouped into 14 clusters (1 to 3 sites per cluster). The decision aid intervention will be sequentially rolled out over the course of 48 weeks to all clusters. None of the clusters will be switched from control to intervention during the first 6 weeks of the study to establish a baseline. Then two clusters will move from the control to the intervention every 6 weeks (called a 'step'). There will be 7 steps total during the study period. At the end of the 7th step all clusters (i.e., participating RUBY sites) will have received the decision aid intervention. The time-point of when the clusters will be switched from control to intervention will be randomized. The data collection includes obtaining secondary data collected as part of the RUBY study from all patient participants who were enrolled in RUBY during the study period. The primary outcome is the number of patients reporting that fertility tools were recommended to them, based on RUBY participant responses to a 3-month fertility questionnaire. The investigators hypothesizes that following the implementation of the decision aid intervention a 20% difference will be observed, from 10% in the control to 30% in the intervention, in the number of patients who report that someone in their care team recommended a fertility tool.
Interventions
BEHAVIORALBEFORE decision aid
Implementation of the BEFORE decision aid in clinical practice
Sponsors
Applied Health Research Centre
Canadian Breast Cancer Foundation
Canadian Institutes of Health Research (CIHR)
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Stepped Wedge Cluster Randomized Trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Young females diagnosed with histologically-confirmed breast cancer will be eligible to participate if they: 1. are age =18 years and prior to their 41st birthday; 2. are able to provide verbal informed consent and complete the interviews in English or French; 3. completed the 3-month fertility questionnaire as part of the RUBY Study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported outcome questionnaire - Fertility Preservation Questionnaire | 3 months from date of randomization | Number of patients reporting that fertility tools were recommended to them following their breast cancer diagnosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BEFORE decision aid online survey - Provider Recommendation of Decision Aid | From date of randomization until the end of the study at 48 weeks | Specific provider who recommended the BEFORE decision aid to the patient |
| BEFORE decision aid online survey - Patient Learning About Decision Aid | From date of randomization until the end of the study at 48 weeks | How the patient first learned about the aid (e.g, by the poster or their care provider) |
| BEFORE decision aid online survey - Patient Satisfaction | From date of randomization until the end of the study at 48 weeks | Patient satisfaction with the way they found out about the BEFORE decision aid |
Other
| Measure | Time frame | Description |
|---|---|---|
| Google Analytics - Decision Aid Download | From date of randomization until the end of the study at 48 weeks | Number of people who downloaded the paper BEFORE decision aid |
| Google Analytics - Number of Visits | From date of randomization until the end of the study at 48 weeks | Number of visits to the BEFORE decision aid |
| Google Analytics - User Location | From date of randomization until the end of the study at 48 weeks | BEFORE decision aid user location by province in Canada |
| Google Analytics - Length of Visits | From date of randomization until the end of the study at 48 weeks | Length of visits to the BEFORE decision aid |
| Google Analytics - Most Visited Page | From date of randomization until the end of the study at 48 weeks | Most visited page on the BEFORE decision aid |
| Google Analytics - Least Visited Page | From date of randomization until the end of the study at 48 weeks | Least visited page on the BEFORE decision aid |
Countries
Canada
Contacts
Primary ContactNancy N Baxter, MD, FRCSC, FACS, PhD
Backup ContactBrittany Speller, MSc
Outcome results
None listed