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

Not Applicable
Completed
Conditions
Prostate Cancer
Interventions
Other: Decision aid
Registration Number
NCT02156869
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
1170
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intervention armDecision aidThe intervention was the use of a decision aid.
Primary Outcome Measures
NameTimeMethod
patients' intent to undergo screening for prostate cancerImmediate

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

SFTG

🇫🇷

Paris, France

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