Patient Educational Materials for Prostate Cancer Screening

A Randomized Trial to Assess Whether Co-creating Patient Educational Materials With Patients Has Added Value Over Researchers and Clinicians Developing Patient Education Materials and Engaging Patients During Usability Testing Only.

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.

Study Overview

• Status: Completed
• Conditions: Patient Educational Materials
• Intervention / Treatment: Other: Co-created PEM

• Study Type: Interventional
• Enrollment (Actual): 573
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• English-speaking men aged 40+ years will be eligible to take part in the project if they have never been diagnosed with prostate cancer and do not have any signs or symptoms of prostate cancer.

Exclusion Criteria:

• Individuals will not be eligible for the project if they indicate that they are a health care professional or have any conflicts of interest relevant to the guideline topic (e.g., owning shares in a company related to prostate cancer treatment).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Co-created PEM; A co-created PEM has been designed in collaboration with patients. Participants receiving the intervention will be asked to read and answer questions before and after viewing the co-created PEM.	Other: Co-created PEM; A co-created PEM has been designed in collaboration with patients.
No Intervention: Traditional PEM; Participants will be asked to read and answer questions before and after viewing the traditional PEM created by clinicians and researchers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pretest-posttest change in prostate cancer screening decisional conflict and intention to be screened between the co-created PEM group and the traditional PEM group.	The investigators will assess differences and changes in prostate cancer screening decisional conflict and intention to be screened for the co-created PEM group and the traditional PEM group using repeated measures ANOVAs.	This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pretest-posttest change in knowledge of prostate cancer screening	The investigators will assess the differences in the pretest-posttest change in prostate cancer screening knowledge between the co-created PEM group and the traditional PEM group using a 7-item knowledge measure. Assessed by conducting a repeated measures analysis of variance (ANOVA).	This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month.
Comparison of PEM usability	The investigators will assess the differences between the two study arms in PEM/recommendation usability using a one-way ANOVA	This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month.
Participant preference of PEM	The investigators will evaluate participants' preferred material (co-created or traditional PEM). Use a chi-square test to analyze the difference in the proportion of patients who prefer each type of material.	This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month
Resources use for PEM development	The investigators will record the resources required (e.g., personnel hours and participant reimbursement) for a health care organization to develop a co-created PEM in comparison to a PEM created by clinicians and researchers.	This measure will be assessed after the intervention (survey) is administered (i.e., post analysis), up to 1 month.

Collaborators and Investigators

• Sponsor: Unity Health Toronto

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2017
• Primary Completion (Actual): October 27, 2017
• Study Completion (Actual): October 27, 2017

Study Registration Dates

• First Submitted: July 11, 2017
• First Submitted That Met QC Criteria: July 17, 2017
• First Posted (Actual): July 19, 2017

Study Record Updates

• Last Update Posted (Actual): November 1, 2017
• Last Update Submitted That Met QC Criteria: October 30, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Patient educational materials; prostate cancer; co-creation
• Other Study ID Numbers: SMH REB #:16-376

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