Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE July 11, 2017
First Posted Date  ICMJE July 19, 2017
Last Update Posted Date November 1, 2017
Actual Study Start Date  ICMJE October 6, 2017
Actual Primary Completion Date October 27, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03222466 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2017)
  • 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).
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patient Educational Materials for Prostate Cancer Screening
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Patient Educational Materials
Intervention  ICMJE Other: Co-created PEM
A co-created PEM has been designed in collaboration with patients.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Co-created PEM
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2017)
573
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2017)
422
Actual Study Completion Date  ICMJE October 27, 2017
Actual Primary Completion Date October 27, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: Male
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03222466
Other Study ID Numbers  ICMJE SMH REB #:16-376
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party St. Michael's Hospital, Toronto
Study Sponsor  ICMJE St. Michael's Hospital, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account St. Michael's Hospital, Toronto
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP