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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Evidence-based information; Other: Patient Decision Aid; Other: Sham information

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.

• Study Type: Interventional
• Enrollment (Actual): 308
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8P0A1
      • McMaster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• English speaking men, > 50 years old

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Evidence + PDA; 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	Other: 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).; Other: Patient Decision Aid; Patient Decision Aid for prostate cancer screening decision
Experimental: Evidence only; 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	Other: 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).
Sham Comparator: Attention control; Information on how to distinguish high from low-quality health information, not specific to cancer screening or PDAs	Other: Sham information; Educational information not specific to PSA testing or cancer screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decisional conflict	Decisional Conflict Scale	Change from baseline to 6-mo

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Canadian Cancer Society (CCS)
• Investigators: Principal Investigator: Maureen Dobbins, RN, PhD, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: March 12, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Screening; Patient Decision Aid; PSA testing
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 4351

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No