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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477591
• Other study ID #: 4351
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: July 1, 2021

Study information

• Verified date: October 2023
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: July 1, 2021
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• English speaking men, > 50 years old

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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).
• Patient Decision Aid
Patient Decision Aid for prostate cancer screening decision
• Sham information
Educational information not specific to PSA testing or cancer screening

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Canadian Cancer Society (CCS)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional conflict	Decisional Conflict Scale	Change from baseline to 6-mo
Secondary	Decision quality	Decision Quality Worksheet for PSA testing	Change from baseline to 6-mo
Secondary	Preparation for decision making	Preparation for decision making scale	Change from baseline to 6-mo
Secondary	Screening behaviour	Congruency between self-reported screening status and stated decision	Change from baseline to 6-mo