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Completed

NCT Number: NCT03222466

Patient Educational Materials for Prostate Cancer Screening

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.

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Key information

Conditions

Patient Educational Materials Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Co-created PEM

Other

A co-created PEM has been designed in collaboration with patients.

Primary outcomes

  1. 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.

    Time frame: This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month.

    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.

Secondary outcomes

  1. Pretest-posttest change in knowledge of prostate cancer screening

    Time frame: This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month.

    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).

  2. Comparison of PEM usability

    Time frame: This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month.

    The investigators will assess the differences between the two study arms in PEM/recommendation usability using a one-way ANOVA

  3. Participant preference of PEM

    Time frame: This measure will be assessed from date of randomization until date of survey completion, assessed up to 1 month

    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.

  4. Resources use for PEM development

    Time frame: This measure will be assessed after the intervention (survey) is administered (i.e., post analysis), up to 1 month.

    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.

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 19, 2017
Registry last updated
Nov 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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