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Patient Educational Materials for Prostate Cancer Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03222466
Recruitment Status : Completed
First Posted : July 19, 2017
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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.

Condition or disease Intervention/treatment Phase
Patient Educational Materials Other: Co-created PEM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 573 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
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.
Actual Study Start Date : October 6, 2017
Actual Primary Completion Date : October 27, 2017
Actual Study Completion Date : October 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03222466


Locations
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Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto

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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03222466     History of Changes
Other Study ID Numbers: SMH REB #:16-376
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Michael's Hospital, Toronto:
Patient educational materials; prostate cancer; co-creation