Evaluating the Impact of Evidence-based Information About PSA Testing on Prostate Cancer Screening Decisions

Not Applicable

Completed

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

• Registration Number: NCT03477591
• 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 men facing prostate cancer screening decisions.

Detailed Description

Guidelines for prostate 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 prostate cancer screening in men.

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: 2018-03-12
• Study First Submitted QC: 2018-03-19
• Study First Posted: 2018-03-26
• Study Start: 2018-10-01
• Primary Completion: 2019-08-30
• Study Completion: 2021-07-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 308

Inclusion Criteria

• English speaking men, > 50 years old

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Exclusion Criteria

• History of prostate cancer or PSA test in the last 12 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Evidence + PDA	Evidence-based information	Evidence-based information on PSA testing 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 + PDA	Patient Decision Aid	Evidence-based information on PSA testing 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
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

Primary Outcome Measures

Name	Time	Method
Decisional conflict	Change from baseline to 6-mo	Decisional Conflict Scale

Secondary Outcome Measures

Name	Time	Method
Decision quality	Change from baseline to 6-mo	Decision Quality Worksheet for PSA testing
Preparation for decision making	Change from baseline to 6-mo	Preparation for decision making scale
Screening behaviour	Change from baseline to 6-mo	Congruency between self-reported screening status and stated decision

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada