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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Evidence-based information
Patient Decision Aid
Sham information
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Prostate Cancer focused on measuring Screening, PSA testing, Patient Decision Aid

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • English speaking men, > 50 years old

Exclusion Criteria:

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

Sites / Locations

  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Evidence + PDA

Evidence only

Attention control

Arm Description

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

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

Information on how to distinguish high from low-quality health information, not specific to cancer screening or PDAs

Outcomes

Primary Outcome Measures

Decisional conflict
Decisional Conflict Scale

Secondary Outcome Measures

Decision quality
Decision Quality Worksheet for PSA testing
Preparation for decision making
Preparation for decision making scale
Screening behaviour
Congruency between self-reported screening status and stated decision

Full Information

First Posted
March 12, 2018
Last Updated
October 17, 2023
Sponsor
McMaster University
Collaborators
Canadian Cancer Society (CCS)
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1. Study Identification

Unique Protocol Identification Number
NCT03477591
Brief Title
Evaluating the Impact of Evidence-based Information About PSA Testing on Prostate Cancer Screening Decisions
Official Title
McMaster Choices Study: Evaluating the Impact of Evidence-based Information About PSA Testing on Prostate Cancer Screening Decisions
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Canadian Cancer Society (CCS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Screening, PSA testing, Patient Decision Aid

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
308 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evidence + PDA
Arm Type
Experimental
Arm Description
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
Arm Title
Evidence only
Arm Type
Experimental
Arm Description
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
Arm Title
Attention control
Arm Type
Sham Comparator
Arm Description
Information on how to distinguish high from low-quality health information, not specific to cancer screening or PDAs
Intervention Type
Other
Intervention Name(s)
Evidence-based information
Intervention Description
Evidence-based information on PSA testing such as blog posts, plain language evidence summaries and web resource ratings (quality-appraised online resources).
Intervention Type
Other
Intervention Name(s)
Patient Decision Aid
Intervention Description
Patient Decision Aid for prostate cancer screening decision
Intervention Type
Other
Intervention Name(s)
Sham information
Intervention Description
Educational information not specific to PSA testing or cancer screening
Primary Outcome Measure Information:
Title
Decisional conflict
Description
Decisional Conflict Scale
Time Frame
Change from baseline to 6-mo
Secondary Outcome Measure Information:
Title
Decision quality
Description
Decision Quality Worksheet for PSA testing
Time Frame
Change from baseline to 6-mo
Title
Preparation for decision making
Description
Preparation for decision making scale
Time Frame
Change from baseline to 6-mo
Title
Screening behaviour
Description
Congruency between self-reported screening status and stated decision
Time Frame
Change from baseline to 6-mo

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: English speaking men, > 50 years old Exclusion Criteria: History of prostate cancer or PSA test in the last 12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen Dobbins, RN, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8P0A1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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