Evaluation StudiesBEFORENCT03629509
Implementation of the Begin Exploring Fertility Options, Risks and Expectations (BEFORE) Decision Aid
A study testing Educational Webinar and Resources in people with Evaluation Studies and Implementation Research, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The Begin Exploring Fertility Options, Risks and Expectations (BEFORE) decision aid was created to support fertility discussions and decision-making for young breast cancer patients in Canada. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Evaluation Studies, Implementation Research, Decision Aid
- What is being tested?
- Educational Webinar and Resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jul 2018to 2 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Eligible patients included those enrolled in the RUBY study during the study period who indicated on a 3-month fertility questionnaire that they were unsure or planning on having one of more (additional) children in the future.
The RUBY study eligibility criteria includes:
- Canadian women between 18 and 40 years of age
- Newly diagnosed with breast cancer (invasive, ductal carcinoma in situ or malignant phyllodes)
- Able to provide informed consent and complete required questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of the Begin Exploring Fertility Options, Risks and Expectations (BEFORE) Decision Aid - a Pragmatic Stepped Wedge Cluster Randomized Trial
The Begin Exploring Fertility Options, Risks and Expectations (BEFORE) decision aid was created to support fertility discussions and decision-making for young breast cancer patients in Canada. While decision aids are valuable as an adjunct to consultations with health care providers, successful implementation in clinical settings following development remains low.
This goal of this study was to evaluate the effectiveness of an educational intervention (a one-hour webinar targeted to oncology nurses introducing the BEFORE decision aid, and posters and handouts in clinical settings) on health care provider recommendations of fertility tools to young breast cancer patients. The main question aims to answer:
Read more
- What is the proportion of patients who were planning or were unsure about having future children who reported their health care provider recommended fertility tools following the intervention?
Data from a fertility questionnaire that young breast cancer patients are completing as part of an ongoing prospective cohort study in Canada will be used to answer the main question.
Read the detailed description
A pragmatic stepped wedge cluster randomized trial was completed by sequentially administering an educational intervention and implementing the BEFORE decision aid in 19 centres across Canada that were recruiting young breast cancer patients for the Reducing the bUrden of Breast cancer in Young women (RUBY) Study (https://www.rubystudy.ca/Home).
There were 19 participating RUBY centres grouped into 12 clusters (1 to 3 centres per cluster). The intervention was sequentially rolled out to all centres between March 2019 and January 2020. Two clusters moved from the control period to the intervention period every 7 weeks (called a 'step'). There was 6 steps plus a baseline step during the study period. At the end of the study period all clusters (i.e., participating RUBY sites) received the intervention. The time-point of when the clusters were switched from control to intervention and the two clusters that received the intervention together was randomized.
Eligible participants included those who indicated they were planning or were unsure about having future children and were enrolled in the RUBY study during the study period. The data collection includes obtaining secondary data collected as part of the RUBY study. Specifically, demographic data and data from a fertility questionnaire completed at 3-months following enrollment in the RUBY study was used to determine the primary outcome.
The primary outcome was the number of patients reporting that their health care provider recommended fertility tools. We hypothesized that following the intervention a 20% difference would be observed, from 10% in the control period to 30% in the intervention period, in the number of patients who report that someone in their care team recommended a fertility tool.
- Conditions
- Evaluation Studies, Implementation Research, Decision Aid, Young Adult Cancer, Educational Intervention, Fertility Perservation
- Being tested
- Educational Webinar and Resources
- Keywords
- decision aid, breast cancer, young females, implementation, stepped wedge trial, education
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Webinar and ResourcesBehavioural
Educational webinar and resources on oncofertility and the BEFORE decision aid
| Study group | Role | What they receive |
|---|---|---|
| Educational Webinar and Resources (EWR) | Experimental | The educational intervention included two aspects:
1. A one hour webinar was conducted with health care providers. The target audience was oncology nurses but any health care provider that discussed fertility with breast cancer patients was able to participate. The webinar was interactive and included an overview of oncofertility, explained how treatment can cause infertility, and provided information on the fertility preservation options available before and after treatment, approximate cost of fertility preservation in Canada, fertility resources, and how to overcome barriers in oncofertility. The webinar also provided an overview on the BEFORE decision aid development and content, along with training on use of the tool in clinical settings.
2. We advertised the availability of the BEFORE decision aid through posters and handouts in clinic areas at each of the centres. Receives: Behavioral: Educational Webinar and Resources |
| No Educational Webinar and Resources (No EWR) | No intervention | Participants in this group did not receive the educational webinar or resources intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported Outcome Questionnaire - Fertility Preservation Questionnaire
The number of patients reporting that their health care provider recommended fertility tools
Measured: 3 months from date of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start30 Jul 2018
- Primary completion2 Mar 2020
- Study completion2 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Evaluation StudiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Stepped Wedge Cluster Randomized Trial. There are 19 centres grouped into 12 clusters with 1-3 centres per cluster. The intervention was rolled out over 6 steps (plus a baseline step) with 2 clusters switching from control to intervention during each step.
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Applied Health Research Centre, Canadian Institutes of Health Research (CIHR), Canadian Cancer Society (CCS)
- Responsible party
- Principal investigator, Nancy Baxter, Unity Health Toronto
- Investigators
- Nancy N Baxter, MD, FRCSC, FACS, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629509
- Sponsor's protocol ID
- 17-361
- Acronym
- BEFORE
- Status last verified
- Jul 2026
- First submitted
- 7 Aug 2018
- Last updated
- 26 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Speller B, Metcalfe K, Kennedy ED, Facey M, Greenblatt E, Scheer AS, Warner E, Joy AA, Wright FC, Baxter NN. The "Begin Exploring Fertility Options, Risks and Expectations" (BEFORE) decision aid: development and alpha testing of a fertility tool for premenopausal breast cancer patients. BMC Med Inform Decis Mak. 2019 Oct 28;19(1):203. doi: 10.1186/s12911-019-0912-y.
PubMed 31660965
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the Begin Exploring Fertility Options, Risks and Expectations (BEFORE) Decision Aid - a Pragmatic Stepped Wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT03629509
- Acronym / sponsor ID
- BEFORE / 17-361
- Conditions
- Evaluation Studies, Implementation Research, Decision Aid, Young Adult Cancer, Educational Intervention, Fertility Perservation
- Keywords
- decision aid, breast cancer, young females, implementation, stepped wedge trial, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Applied Health Research Centre, Canadian Institutes of Health Research (CIHR), Canadian Cancer Society (CCS)
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Posted 26 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Begin Exploring Fertility Options, Risks and Expectations (BEFORE) decision aid was created to support fertility discussions and decision-making for young breast cancer patients in Canada. While decision aids are valuable as an adjunct to consultations with health care providers, successful implementation in clinical settings following development remains low.
This goal of this study was to evaluate the effectiveness of an educational intervention (a one-hour webinar targeted to oncology nurses introducing the BEFORE decision aid, and posters and handouts in clinical settings) on health care provider recommendations of fertility tools to young breast cancer patients. The main question aims to answer:
- What is the proportion of patients who were planning or were unsure about having future children who reported their health care provider recommended fertility tools following the intervention?
Data from a fertility questionnaire that young breast cancer patients are completing as part of an ongoing prospective cohort study in Canada will be used to answer the main question.
Detailed description
A pragmatic stepped wedge cluster randomized trial was completed by sequentially administering an educational intervention and implementing the BEFORE decision aid in 19 centres across Canada that were recruiting young breast cancer patients for the Reducing the bUrden of Breast cancer in Young women (RUBY) Study (https://www.rubystudy.ca/Home).
There were 19 participating RUBY centres grouped into 12 clusters (1 to 3 centres per cluster). The intervention was sequentially rolled out to all centres between March 2019 and January 2020. Two clusters moved from the control period to the intervention period every 7 weeks (called a 'step'). There was 6 steps plus a baseline step during the study period. At the end of the study period all clusters (i.e., participating RUBY sites) received the intervention. The time-point of when the clusters were switched from control to intervention and the two clusters that received the intervention together was randomized.
Eligible participants included those who indicated they were planning or were unsure about having future children and were enrolled in the RUBY study during the study period. The data collection includes obtaining secondary data collected as part of the RUBY study. Specifically, demographic data and data from a fertility questionnaire completed at 3-months following enrollment in the RUBY study was used to determine the primary outcome.
The primary outcome was the number of patients reporting that their health care provider recommended fertility tools. We hypothesized that following the intervention a 20% difference would be observed, from 10% in the control period to 30% in the intervention period, in the number of patients who report that someone in their care team recommended a fertility tool.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped Wedge Cluster Randomized Trial. There are 19 centres grouped into 12 clusters with 1-3 centres per cluster. The intervention was rolled out over 6 steps (plus a baseline step) with 2 clusters switching from control to intervention during each step.
| Arm | Type | Receives |
|---|---|---|
| Educational Webinar and Resources (EWR) | Experimental | Behavioral: Educational Webinar and ResourcesThe educational intervention included two aspects: 1. A one hour webinar was conducted with health care providers. The target audience was oncology nurses but any health care provider that discussed fertility with breast cancer patients was able to participate. The webinar was interactive and included an overview of oncofertility, explained how treatment can cause infertility, and provided information on the fertility preservation options available before and after treatment, approximate cost of fertility preservation in Canada, fertility resources, and how to overcome barriers in oncofertility. The webinar also provided an overview on the BEFORE decision aid development and content, along with training on use of the tool in clinical settings. 2. We advertised the availability of the BEFORE decision aid through posters and handouts in clinic areas at each of the centres. |
| No Educational Webinar and Resources (No EWR) | No intervention | –Participants in this group did not receive the educational webinar or resources intervention. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Webinar and ResourcesEducational webinar and resources on oncofertility and the BEFORE decision aid | Behavioural | Educational Webinar and Resources (EWR) |
Primary outcome
Patient-reported Outcome Questionnaire - Fertility Preservation Questionnaire
Time frame: 3 months from date of randomization
The number of patients reporting that their health care provider recommended fertility tools
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31660965Speller B, Metcalfe K, Kennedy ED, Facey M, Greenblatt E, Scheer AS, Warner E, Joy AA, Wright FC, Baxter NN. The "Begin Exploring Fertility Options, Risks and Expectations" (BEFORE) decision aid: development and alpha testing of a fertility tool for premenopausal breast cancer patients. BMC Med Inform Decis Mak. 2019 Oct 28;19(1):203. doi: 10.1186/s12911-019-0912-y.
- Reducing the bUrden of Breast cancer in Young women (RUBY) Study - cohort of young females to use secondary data from to determine outcomes following the implementation of the BEFORE decision aidLink provided by the sponsor.
- Begin Exploring Fertility Options, Risks and Expectations (BEFORE) decision aidLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy N Baxter, MD, FRCSC, FACS, PhD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Webinar and Resources in people with Evaluation Studies and Implementation Research, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported Outcome Questionnaire - Fertility Preservation Questionnaire (time frame: 3 months from date of randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03629509, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.