Evaluating the Impact of Evidence-based Information About Mammography on Breast Cancer Screening Decisions

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT03631758
• Lead Sponsor: McMaster University

Brief Summary

Patient decision aids are tools that help guide individuals through a healthcare-related decision making process. They help users combine evidence-based information and recommendations by a health care provider with their personal needs, values and preferences. Through this project, Dr. Dobbins and her research team will explore whether the use of patient decision aids with high-quality and user-friendly summaries of research evidence, or summaries of research evidence alone, help to improve the quality of decision making by women facing breast cancer screening decisions.

Detailed Description

Guidelines for breast screening in Canada are based on low-moderate quality evidence of effectiveness and screening is associated with potential harms. Patient Decision Aids (PDAs) are tools that assist users to understand treatment options, risks and benefits to align decisions with values and preferences. The investigators would now like to know whether use of a PDA alongside evidence-based information provided through the McMaster Optimal Aging Portal, or simply access to evidence-based information alone, can help users to make informed decisions about breast cancer screening in women.

Study Timeline

• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-15
• Study Start: 2019-01-01
• Primary Completion: 2020-01-31
• Study Completion: 2020-12-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 209

Inclusion Criteria

• English speaking women, 40-49 years old
• Residents of British Columbia, Nova Scotia, and Prince Edward Island

Exclusion Criteria

• History of breast cancer or mammography in the last 12 months
• Classified as above-average risk for breast cancer (i.e., known genetic mutation linked to BC; no genetic testing, but a parent, sibling or child with a genetic mutation linked to BC; or received chest wall radiation before age 30)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Decisional Conflict Scale	Change from baseline to 6-mo	A validated scale in which items are summed and scored to create a total score. Scores range from 0 to 100, with higher scores indicating higher decisional conflict.

Secondary Outcome Measures

Name	Time	Method
Preparation for Decision Making Scale	Change from baseline to 6-mo	A validated scale, items are summed and scored to create a score of 0-100. Higher scores indicate higher preparation for decision making
Screening behaviour	Change from baseline to 6-mo	Congruency between self-reported screening status and stated decision
Decision quality	Change from baseline to 6-mo	Decision Quality Worksheet for Mammography

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada