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Evaluating the Impact of Evidence-based Information About PSA Testing on Prostate Cancer Screening Decisions

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: NCT03477591
Recruitment Status : Active, not recruiting
First Posted : March 26, 2018
Last Update Posted : September 2, 2020
Sponsor:
Collaborator:
Canadian Cancer Society Research Institute (CCSRI)
Information provided by (Responsible Party):
McMaster University

Brief Summary:
Patient decision aids are tools that help guide individuals through a healthcare-related decision making process. They help users combine evidence-based information and recommendations by a health care provider with their personal needs, values and preferences. Through this project, Dr. Dobbins and her research team will explore whether the use of patient decision aids with high-quality and user-friendly summaries of research evidence, or summaries of research evidence alone, help to improve the quality of decision making by men facing prostate cancer screening decisions.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Evidence-based information Other: Patient Decision Aid Other: Sham information Not Applicable

Detailed Description:
Guidelines for prostate screening in Canada are based on low-moderate quality evidence of effectiveness and screening is associated with potential harms. Patient Decision Aids (PDAs) are tools that assist users to understand treatment options, risks and benefits to align decisions with values and preferences. The investigators would now like to know whether use of a PDA alongside evidence-based information provided through the McMaster Optimal Aging Portal, or simply access to evidence-based information alone, can help users to make informed decisions about prostate cancer screening in men.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: McMaster Choices Study: Evaluating the Impact of Evidence-based Information About PSA Testing on Prostate Cancer Screening Decisions
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : August 30, 2019
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Evidence + PDA
Evidence-based information on PSA testing such as blog posts, plain language evidence summaries and web resource ratings (quality-appraised online resources), plus a blog post on PDAs and the relevant decision aid from the Portal database
Other: Evidence-based information
Evidence-based information on PSA testing such as blog posts, plain language evidence summaries and web resource ratings (quality-appraised online resources).

Other: Patient Decision Aid
Patient Decision Aid for prostate cancer screening decision

Experimental: Evidence only
The same evidence-based information as group 1 (Evidence + PDA), but without the PDA to quantify the effect of accessing evidence through the Portal alone
Other: Evidence-based information
Evidence-based information on PSA testing such as blog posts, plain language evidence summaries and web resource ratings (quality-appraised online resources).

Sham Comparator: Attention control
Information on how to distinguish high from low-quality health information, not specific to cancer screening or PDAs
Other: Sham information
Educational information not specific to PSA testing or cancer screening




Primary Outcome Measures :
  1. Decisional conflict [ Time Frame: Change from baseline to 6-mo ]
    Decisional Conflict Scale


Secondary Outcome Measures :
  1. Decision quality [ Time Frame: Change from baseline to 6-mo ]
    Decision Quality Worksheet for PSA testing

  2. Preparation for decision making [ Time Frame: Change from baseline to 6-mo ]
    Preparation for decision making scale

  3. Screening behaviour [ Time Frame: Change from baseline to 6-mo ]
    Congruency between self-reported screening status and stated decision



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • English speaking men, > 50 years old

Exclusion Criteria:

  • History of prostate cancer or PSA test in the last 12 months

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): NCT03477591


Locations
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Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8P0A1
Sponsors and Collaborators
McMaster University
Canadian Cancer Society Research Institute (CCSRI)
Investigators
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Principal Investigator: Maureen Dobbins, RN, PhD McMaster University
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03477591    
Other Study ID Numbers: 4351
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020
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 McMaster University:
Screening
PSA testing
Patient Decision Aid
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases