NCT03222466

Patient Educational Materials for Prostate Cancer Screening

Completed NA Last updated 1 November 2017

What this trial tests

NA trial testing Co-created PEM in Patient Educational Materials in 573 participants. Completed in 27 October 2017.

Timeline

6 October 2017

Primary endpoint
27 October 2017

27 October 2017

Quick facts

Lead sponsor	Unity Health Toronto
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	health services research
Enrollment	573
Start date	6 October 2017
Primary completion	27 October 2017
Estimated completion	27 October 2017
Sites	1 location across Canada

Drugs / interventions tested

• Co-created PEM

Conditions studied

• Patient Educational Materials — all drugs for Patient Educational Materials →

Sponsor

Unity Health Toronto — full company profile →

Who can join

40 and older, any sex, with Patient Educational Materials. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Although the harms of screening for prostate cancer with the prostate-specific antigen (PSA) test outweigh the benefits, 560,000 Ontario men undergo PSA screening each year. Guideline developers, such as the Canadian Task Force on Preventive Health Care (CTFPHC), have disseminated patient educational materials (PEMs) on PSA screening widely in Ontario, yet men remain confused about screening harms and benefits. One potential contributing factor may be that PEMs are typically developed by researchers and clinicians and may not address patient barriers to change. The investigators will assess whether a PSA screening PEM that is co-created with patients provides added value over PEMs developed using the traditional approach (i.e., researchers and clinicians develop a PEM with patient involvement in usability testing only. The investigators will also assess satisfaction with the engagement process and calculate the costs and resources required for each method (i.e. co-creation, usability, and recommendations only). This study will generate a PSA screening PEM to help patients make evidence-based screening decisions. It will also help Ontario organizations, including Cancer Care Ontario, identify optimal methods for developing PEMs for PSA screening and other areas of preventive health care, such as breast and colorectal cancer screening.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of consumers and health providers working in partnership on health services planning, delivery and evaluation.
   Lowe D, Ryan R, Schonfeld L, Merner B, et al · · 2021 · cited 30× · PMID 34523117 · DOI 10.1002/14651858.cd013373.pub2
2. Are patient education materials about cancer screening more effective when co-created with patients? A qualitative interview study and randomized controlled trial.
   Bashir NY, Moore JE, Buckland D, Rodrigues M, et al · · 2019 · cited 11× · PMID 31043815 · DOI 10.3747/co.26.4621