BEFORE Decision Aid Implementation Study

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03629509
• Other study ID #: 17-361
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2018
• Source: St. Michael's Hospital, Toronto
• Contact: Nancy N Baxter, MD, FRCSC, FACS, PhD
• Phone: 416-864-6060
• Email: baxtern[@]smh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 224
• Est. completion date: December 31, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Applied Health Research Centre, Canadian Breast Cancer Foundation, Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Google Analytics - Number of Visits	Number of visits to the BEFORE decision aid	From date of randomization until the end of the study at 48 weeks
Other	Google Analytics - Length of Visits	Length of visits to the BEFORE decision aid	From date of randomization until the end of the study at 48 weeks
Other	Google Analytics - Most Visited Page	Most visited page on the BEFORE decision aid	From date of randomization until the end of the study at 48 weeks
Other	Google Analytics - Least Visited Page	Least visited page on the BEFORE decision aid	From date of randomization until the end of the study at 48 weeks
Other	Google Analytics - Decision Aid Download	Number of people who downloaded the paper BEFORE decision aid	From date of randomization until the end of the study at 48 weeks
Other	Google Analytics - User Location	BEFORE decision aid user location by province in Canada	From date of randomization until the end of the study at 48 weeks
Primary	Patient-reported outcome questionnaire - Fertility Preservation Questionnaire	Number of patients reporting that fertility tools were recommended to them following their breast cancer diagnosis	3 months from date of randomization
Secondary	BEFORE decision aid online survey - Provider Recommendation of Decision Aid	Specific provider who recommended the BEFORE decision aid to the patient	From date of randomization until the end of the study at 48 weeks
Secondary	BEFORE decision aid online survey - Patient Learning About Decision Aid	How the patient first learned about the aid (e.g, by the poster or their care provider)	From date of randomization until the end of the study at 48 weeks
Secondary	BEFORE decision aid online survey - Patient Satisfaction	Patient satisfaction with the way they found out about the BEFORE decision aid	From date of randomization until the end of the study at 48 weeks

External Links

•   BEFORE decision aid
•   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 aid