BEFORE Decision Aid Implementation Study

NCT03629509 | Unknown

• 1 other identifier: 17-361
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

decision aid; breast cancer; young females; implementation; stepped wedge trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• BEFORE decision aid online survey - Provider Recommendation of Decision Aid

  From date of randomization until the end of the study at 48 weeks

• BEFORE decision aid online survey - Patient Learning About Decision Aid

  From date of randomization until the end of the study at 48 weeks

• BEFORE decision aid online survey - Patient Satisfaction

  From date of randomization until the end of the study at 48 weeks

Other Outcomes (6)

• Google Analytics - Number of Visits

  From date of randomization until the end of the study at 48 weeks

• Google Analytics - Length of Visits

  From date of randomization until the end of the study at 48 weeks

• Google Analytics - Most Visited Page

  From date of randomization until the end of the study at 48 weeks

Study Arms (3)

Pre-Intervention

OTHER

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

BEFORE Decision Aid Intervention

EXPERIMENTAL

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

Post-Intervention

OTHER

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

Interventions

BEFORE decision aid BEHAVIORAL

Implementation of the BEFORE decision aid in clinical practice

BEFORE Decision Aid Intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Young females diagnosed with histologically-confirmed breast cancer will be eligible to participate if they:
• are age =18 years and prior to their 41st birthday;
• are able to provide verbal informed consent and complete the interviews in English or French;
• completed the 3-month fertility questionnaire as part of the RUBY Study.

Sponsors & Collaborators

• Unity Health Toronto: lead
• Applied Health Research Centre: collaborator
• Canadian Breast Cancer Foundation: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Links

• BEFORE decision aid

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nancy N Baxter, MD, FRCSC, FACS, PhD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy N Baxter, MD, FRCSC, FACS, PhD

CONTACT

416-864-6060; baxtern@smh.ca

Brittany Speller, MSc

CONTACT

416-864-6060; spellerb@smh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of General Surgery, Scientist

Model Details: Stepped Wedge Cluster Randomized Trial

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 14, 2018
• Study Start: September 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: December 31, 2019
• Last Updated: August 14, 2018

Record last verified: 2018-08

Locations

CA (1)