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| Name | Class |
|---|---|
| Applied Health Research Centre | OTHER |
| Canadian Breast Cancer Foundation | OTHER |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Intervention | Other | The BEFORE decision aid will be available for use on the RUBY communication portals (Twitter, Facebook and study portal) Data will be collected 6 weeks before the implementation of the BEFORE decision aid in RUBY sites to establish a baseline |
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| BEFORE Decision Aid Intervention | Experimental | Evaluate more intensive strategies to promote use of the BEFORE decision aid through:
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| Post-Intervention | Other | Data will be collected after the BEFORE decision aid has been implemented in each RUBY site regarding the recommendation of fertility resources, most useful/least useful tool, and use of the BEFORE decision aid. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BEFORE decision aid | Behavioral | Implementation of the BEFORE decision aid in clinical practice |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported outcome questionnaire - Fertility Preservation Questionnaire | Number of patients reporting that fertility tools were recommended to them following their breast cancer diagnosis | 3 months from date of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| BEFORE decision aid online survey - Provider Recommendation of Decision Aid | Specific provider who recommended the BEFORE decision aid to the patient | From date of randomization until the end of the study at 48 weeks |
| BEFORE decision aid online survey - Patient Learning About Decision Aid |
| Measure | Description | Time Frame |
|---|---|---|
| Google Analytics - Number of Visits | Number of visits to the BEFORE decision aid | From date of randomization until the end of the study at 48 weeks |
| Google Analytics - Length of Visits | Length of visits to the BEFORE decision aid |
Inclusion Criteria:
Young females diagnosed with histologically-confirmed breast cancer will be eligible to participate if they:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nancy N Baxter, MD, FRCSC, FACS, PhD | Contact | 416-864-6060 | 77021 | baxtern@smh.ca |
| Brittany Speller, MSc | Contact | 416-864-6060 | 77029 | spellerb@smh.ca |
| Name | Affiliation | Role |
|---|---|---|
| Nancy N Baxter, MD, FRCSC, FACS, PhD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
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| Label | URL |
|---|---|
| BEFORE decision aid | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 17, 2023 | |
| Reset | Dec 15, 2023 | |
| Release | Dec 28, 2025 | |
| Reset | Jan 15, 2026 | |
| Release | Mar 27, 2026 | |
| Reset | Apr 16, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 17, 2023 | Dec 15, 2023 | |||
| Dec 28, 2025 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Stepped Wedge Cluster Randomized Trial
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| BEFORE decision aid | Behavioral | Implementation of the BEFORE decision aid on RUBY communication portals |
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| BEFORE decision aid | Behavioral | Review impact of BEFORE decision aid implementation in clinical practice |
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How the patient first learned about the aid (e.g, by the poster or their care provider) |
| From date of randomization until the end of the study at 48 weeks |
| BEFORE decision aid online survey - Patient Satisfaction | Patient satisfaction with the way they found out about the BEFORE decision aid | From date of randomization until the end of the study at 48 weeks |
| From date of randomization until the end of the study at 48 weeks |
| Google Analytics - Most Visited Page | Most visited page on the BEFORE decision aid | From date of randomization until the end of the study at 48 weeks |
| Google Analytics - Least Visited Page | Least visited page on the BEFORE decision aid | From date of randomization until the end of the study at 48 weeks |
| Google Analytics - Decision Aid Download | Number of people who downloaded the paper BEFORE decision aid | From date of randomization until the end of the study at 48 weeks |
| Google Analytics - User Location | BEFORE decision aid user location by province in Canada | From date of randomization until the end of the study at 48 weeks |
| Jan 15, 2026 |
| Mar 27, 2026 | Apr 16, 2026 |
| D017437 |
| Skin and Connective Tissue Diseases |