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

NCT03477591 | Completed

• 1 other identifier: 4351
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Screening; PSA testing; Patient Decision Aid

Outcome Measures

Primary Outcomes (1)

• Decisional conflict

  Decisional Conflict Scale

  Change from baseline to 6-mo

Secondary Outcomes (3)

• Decision quality

  Change from baseline to 6-mo

• Preparation for decision making

  Change from baseline to 6-mo

• Screening behaviour

  Change from baseline to 6-mo

Study Arms (3)

Evidence + PDA

EXPERIMENTAL

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; Other: Patient Decision Aid

Evidence only

EXPERIMENTAL

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

Attention control

SHAM COMPARATOR

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

Other: Sham information

Interventions

Evidence-based information OTHER

Evidence-based information on PSA testing such as blog posts, plain language evidence summaries and web resource ratings (quality-appraised online resources).

Evidence + PDA; Evidence only

Patient Decision Aid OTHER

Patient Decision Aid for prostate cancer screening decision

Evidence + PDA

Sham information OTHER

Educational information not specific to PSA testing or cancer screening

Attention control

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking men, \> 50 years old

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead
• Canadian Cancer Society (CCS): collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8P0A1, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Maureen Dobbins, RN, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 26, 2018
• Study Start: October 1, 2018
• Primary Completion: August 30, 2019
• Study Completion: July 1, 2021
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)