NCT03629509

BEFORE Decision Aid Implementation Study

Implementation of the Begin Exploring Fertility Options, Risks and Expectations (BEFORE) Decision Aid - A Stepped Wedge Cluster Randomized Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Decision Support Techniques
• Breast Neoplasm Female
• Young Adult
• Evaluation Studies

Interventions

Type	Name	Description
BEHAVIORAL	BEFORE decision aid	Implementation of the BEFORE decision aid in clinical practice
BEHAVIORAL	BEFORE decision aid	Implementation of the BEFORE decision aid on RUBY communication portals
BEHAVIORAL	BEFORE decision aid	Review impact of BEFORE decision aid implementation in clinical practice

Timeline

• Start date: 2018-09-01
• Primary completion: 2019-10-01
• Completion: 2019-12-31
• First posted: 2018-08-14
• Last updated: 2018-08-14

Locations

1 site across 1 country: Canada