Clinical trial NCT03222466: Patient Educational Materials for Prostate Cancer Screening
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Educational Materials
Keywords: Patient educational materials; prostate cancer; co-creation
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 573
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: 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.
timeFrame: This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month.
Secondary outcomes:
measure: Pretest-posttest change in knowledge of prostate cancer screening
timeFrame: This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month.
measure: Comparison of PEM usability
timeFrame: This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month.
measure: Participant preference of PEM
timeFrame: This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month
measure: Resources use for PEM development
timeFrame: This measure will be assessed after the intervention (survey) is administered (i.e., post analysis), up to 1 month.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
References: