Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
224 participants
INTERVENTIONAL
2018-09-01
2019-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Increasing Patients' Engagement in Breast Cancer Surgery Decision-Making
NCT03766009
Decision Aid Website in Helping to Make Decisions About Fertility in Participants With Cancer
NCT03141437
Facilitating Web-based Patient Decision Support: Decision About Medication to Lower Breast Cancer Risk
NCT00906321
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
NCT03591848
Pilot Study of a Decision Aid Intervention for Family-building After Cancer
NCT04059237
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pre-Intervention
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
BEFORE decision aid
Implementation of the BEFORE decision aid on RUBY communication portals
BEFORE Decision Aid Intervention
Evaluate more intensive strategies to promote use of the BEFORE decision aid through:
1. We will advertise the availability of the BEFORE decision aid with posters placed in clinic areas at each RUBY site, and will have small handouts available to be distributed in clinic.
2. We will conduct an educational intervention describing and promoting the use of the BEFORE decision aid and general oncofertility information to nurses and support staff at each RUBY site. This will include an optional 1hr informational webinar, direct outreach and training of nurses/support staff on the use of the tool.
BEFORE decision aid
Implementation of the BEFORE decision aid in clinical practice
Post-Intervention
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.
BEFORE decision aid
Review impact of BEFORE decision aid implementation in clinical practice
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BEFORE decision aid
Implementation of the BEFORE decision aid in clinical practice
BEFORE decision aid
Implementation of the BEFORE decision aid on RUBY communication portals
BEFORE decision aid
Review impact of BEFORE decision aid implementation in clinical practice
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
18 Years
40 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Applied Health Research Centre
OTHER
Canadian Breast Cancer Foundation
OTHER
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Unity Health Toronto
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nancy Baxter
Chief of General Surgery, Scientist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nancy N Baxter, MD, FRCSC, FACS, PhD
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St. Michael's Hospital
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
17-361
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.