Clinical trial NCT03629509: BEFORE Decision Aid Implementation Study
Official title: Implementation of the Begin Exploring Fertility Options, Risks and Expectations (BEFORE) Decision Aid - A Stepped Wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Decision Support Techniques
Breast Neoplasm Female
Young Adult
Evaluation Studies
Keywords: decision aid
breast cancer
young females
implementation
stepped wedge trial
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Applied Health Research Centre
name: Canadian Breast Cancer Foundation
name: Canadian Institutes of Health Research (CIHR)
First posted: 2018-08-14
Enrollment: 224
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped Wedge Cluster Randomized Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient-reported outcome questionnaire - Fertility Preservation Questionnaire
timeFrame: 3 months from date of randomization
Secondary outcomes:
measure: BEFORE decision aid online survey - Provider Recommendation of Decision Aid
timeFrame: From date of randomization until the end of the study at 48 weeks
measure: BEFORE decision aid online survey - Patient Learning About Decision Aid
timeFrame: From date of randomization until the end of the study at 48 weeks
measure: BEFORE decision aid online survey - Patient Satisfaction
timeFrame: From date of randomization until the end of the study at 48 weeks
Other outcomes:
measure: Google Analytics - Number of Visits
timeFrame: From date of randomization until the end of the study at 48 weeks
measure: Google Analytics - Length of Visits
timeFrame: From date of randomization until the end of the study at 48 weeks
measure: Google Analytics - Most Visited Page
timeFrame: From date of randomization until the end of the study at 48 weeks
measure: Google Analytics - Least Visited Page
timeFrame: From date of randomization until the end of the study at 48 weeks
measure: Google Analytics - Decision Aid Download
timeFrame: From date of randomization until the end of the study at 48 weeks
measure: Google Analytics - User Location
timeFrame: From date of randomization until the end of the study at 48 weeks
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Nancy N Baxter, MD, FRCSC, FACS, PhD
role: PRINCIPAL_INVESTIGATOR
References: