BEFORE Decision Aid Implementation Study

August 11, 2018 updated by: Nancy Baxter, Unity Health Toronto

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

224

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nancy N Baxter, MD, FRCSC, FACS, PhD
  • Phone Number: 77021 416-864-6060
  • Email: baxtern@smh.ca

Study Contact Backup

  • Name: Brittany Speller, MSc
  • Phone Number: 77029 416-864-6060
  • Email: spellerb@smh.ca

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
        • Contact:
          • Brittany, Speller
          • Phone Number: 77029 416-864-6060
          • Email: spellerb@smh.ca
        • Sub-Investigator:
          • May Lynn Quan, MD, MSc, FRCSC
        • Sub-Investigator:
          • Ellen Warner, MD, FRCPC, FACP, MSc
        • Sub-Investigator:
          • Adena Scheer, MD, FRCSC, MSc
        • Sub-Investigator:
          • Erin Kennedy, MD, PhD, FRCSC
        • Sub-Investigator:
          • Kelly Metcalfe, RN, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
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
Experimental: 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.
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
Other: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported outcome questionnaire - Fertility Preservation Questionnaire
Time Frame: 3 months from date of randomization
Number of patients reporting that fertility tools were recommended to them following their breast cancer diagnosis
3 months from date of randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BEFORE decision aid online survey - Provider Recommendation of Decision Aid
Time Frame: From date of randomization until the end of the study at 48 weeks
Specific provider who recommended the BEFORE decision aid to the patient
From date of randomization until the end of the study at 48 weeks
BEFORE decision aid online survey - Patient Learning About Decision Aid
Time Frame: From date of randomization until the end of the study at 48 weeks
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
BEFORE decision aid online survey - Patient Satisfaction
Time Frame: From date of randomization until the end of the study at 48 weeks
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Google Analytics - Number of Visits
Time Frame: From date of randomization until the end of the study at 48 weeks
Number of visits to the BEFORE decision aid
From date of randomization until the end of the study at 48 weeks
Google Analytics - Length of Visits
Time Frame: From date of randomization until the end of the study at 48 weeks
Length of visits to the BEFORE decision aid
From date of randomization until the end of the study at 48 weeks
Google Analytics - Most Visited Page
Time Frame: From date of randomization until the end of the study at 48 weeks
Most visited page on the BEFORE decision aid
From date of randomization until the end of the study at 48 weeks
Google Analytics - Least Visited Page
Time Frame: From date of randomization until the end of the study at 48 weeks
Least visited page on the BEFORE decision aid
From date of randomization until the end of the study at 48 weeks
Google Analytics - Decision Aid Download
Time Frame: From date of randomization until the end of the study at 48 weeks
Number of people who downloaded the paper BEFORE decision aid
From date of randomization until the end of the study at 48 weeks
Google Analytics - User Location
Time Frame: From date of randomization until the end of the study at 48 weeks
BEFORE decision aid user location by province in Canada
From date of randomization until the end of the study at 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Collaborators

Canadian Institutes of Health Research (CIHR)
Canadian Breast Cancer Foundation
Applied Health Research Centre

Investigators

  • Principal Investigator: Nancy N Baxter, MD, FRCSC, FACS, PhD, Unity Health Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2018

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

August 7, 2018

First Submitted That Met QC Criteria

August 11, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 11, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-361

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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