Breast Neoplasm Female Clinical Trial
Official title:
Implementation of the Begin Exploring Fertility Options, Risks and Expectations (BEFORE) Decision Aid - A Stepped Wedge Cluster Randomized Trial
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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