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Impact of a Printed Decision Aid on Patients' Intent to Undertake Prostate Cancer Screening (PSAMG)

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ClinicalTrials.gov Identifier: NCT02156869
Recruitment Status : Completed
First Posted : June 5, 2014
Last Update Posted : June 5, 2014
Sponsor:
Collaborator:
University of Paris 5 - Rene Descartes
Information provided by (Responsible Party):
TRAN Viet thi, University Paris 7 - Denis Diderot

Brief Summary:

Although the number of recommendations against systematic screening of prostate cancer, 70% of patients still request testing because they overestimate the benefits and are unaware of the limitations.

The investigators aim is to assess the impact of a short printed decision aid presenting benefits and limits of screening, on patients' intent to undergo prostate cancer screening.


Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Decision aid Not Applicable

Detailed Description:

A Cochrane systematic review of 5 randomized controlled trials showed that screening for prostate cancer, using digital rectal examination and dosage of prostate specific antigen (PSA), did not significantly decrease prostate cancer specific mortality. Rather, screening for prostate cancer often led to over-diagnosis by detecting tumors that would not otherwise have become symptomatic or by producing false positive results. It could therefore result in unnecessary supplementary testing (including prostate biopsies), inadequate and/or harmful treatment, and negative psychological outcomes among patients.

Although the growing number of recommendations against PSA testing for screening of prostate cancer, 70% of patients still request testing prior to any information because they overestimate the benefits and are unaware of the limitations. As a result, about 55% of patients between 50 and 74 years old, undergo prostate cancer screening in the USA every year, despite recommendations against it.

To help patients understand the complexities about PSA testing for prostate cancer screening, professional organizations encourage physicians and patients to use decision aids to make informed decisions.

The aim of this study was to evaluate the impact of a decision aid, usable in daily practice by general practitioners, presenting harms and benefits of prostate cancer screening on patients' intent to undergo screening.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Impact of a Printed Decision Aid on Patients' Intent to Undertake Prostate Cancer Screening: a Multicenter Pragmatic Randomized Controlled Trial
Study Start Date : November 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Intervention arm
The intervention was the use of a decision aid.
Other: Decision aid
Intervention was use of a decision aid. Decision aid contained information about: 1) the epidemiology of prostate cancer; 2) what is a PSA test and advantages and limits of screening for prostate cancer using it (including risk of overtreatment and risk of becoming impotent and/or incontinent) and; 3) the position on screening for prostate cancer of major scientific societies in France at the time of the study. The second page contained a visual representation of the benefits of PSA screening for prostate cancer versus usual care based on the results of the European Randomized study of Screening for Prostate Cancer trial (ERSPC) The decision aid was pretested with 20 patients to ensure clarity and wording. It was revised accordingly to comments.

No Intervention: Control arm
Usual care



Primary Outcome Measures :
  1. patients' intent to undergo screening for prostate cancer [ Time Frame: Immediate ]
    patients' intent to undergo screening for prostate cancer was assessed by the question: "Do you want to be screened (or in case you have already been screened before, do intend to continue to be screened) for prostate cancer?" in a self administered questionnaire. Patients could answer "Yes", "No" or "I don't know", measured one time after receiving the decision aid or not.


Other Outcome Measures:
  1. Reasons to undergo or not screening for prostate cancer [ Time Frame: Immediate ]
    We systematically asked patients to elicit reasons underlying their answers using open-ended questions. Answers were read by a single investigator (EKR) and classified into categories. We compared proportion of individuals eliciting ech reason between the 2 arms



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male patients from 50 to 75 years old

Exclusion Criteria:

  • personal history of prostate cancer
  • any urinary tract symptoms
  • history of prostate cancer in a first degree relative
  • known exposition to chlordecone

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): NCT02156869


Locations
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France
SFTG
Paris, France, 75000
Sponsors and Collaborators
University Paris 7 - Denis Diderot
University of Paris 5 - Rene Descartes
Investigators
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Principal Investigator: Viet Thi Tran, MD Paris Diderot University

Publications:
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Responsible Party: TRAN Viet thi, Assistant professor, University Paris 7 - Denis Diderot
ClinicalTrials.gov Identifier: NCT02156869     History of Changes
Other Study ID Numbers: DMG1
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: June 5, 2014
Last Verified: June 2014

Keywords provided by TRAN Viet thi, University Paris 7 - Denis Diderot:
Prostate cancer
Screening
Decision aids

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases