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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: Evidence-based information; Other: Sham information; Behavioral: Patient Decision Aid

• 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Evidence + PDA	Evidence-based information	Evidence-based information on mammography such as blog posts, plain language evidence summaries and web resource ratings (quality-appraised online resources), plus a blog post on PDAs and the relevant decision aid from the Portal database
Attention control	Sham information	Information on how to distinguish high from low-quality health information, not specific to cancer screening or PDAs
Evidence only	Evidence-based information	The same evidence-based information as group 1 (Evidence + PDA), but without the PDA to quantify the effect of accessing evidence through the Portal alone
Experimental: Evidence + PDA	Patient Decision Aid	Evidence-based information on mammography such as blog posts, plain language evidence summaries and web resource ratings (quality-appraised online resources), plus a blog post on PDAs and the relevant decision aid from the Portal database

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