Patient Educational Materials for Prostate Cancer Screening

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Patient Educational Materials

Intervention / Treatment
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* Other: Co-created PEM


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Co-created PEM<br>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<br>* A co-created PEM has been designed in collaboration with patients.<br>|
| No Intervention: Traditional PEM<br>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?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient educational materials; prostate cancer; co-creation