Clinical trial NCT02156869: Impact of a Printed Decision Aid on Patients' Intent to Undertake Prostate Cancer Screening
Official title: Impact of a Printed Decision Aid on Patients' Intent to Undertake Prostate Cancer Screening: a Multicenter Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
Screening
Decision aids
Lead sponsor: University Paris 7 - Denis Diderot
Sponsor class: OTHER
Collaborators: name: University of Paris 5 - Rene Descartes
First posted: 2014-06-05
Enrollment: 1170
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility 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

Primary outcomes:
measure: patients' intent to undergo screening for prostate cancer
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
measure: Reasons to undergo or not screening for prostate cancer
timeFrame: Immediate
Locations:
city: Paris
country: France
facility: SFTG
Study officials:
affiliation: Paris Diderot University
name: Viet Thi Tran, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moyer VA; U.S. Preventive Services Task Force. Screening for prostate cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012 Jul 17;157(2):120-34. doi: 10.7326/0003-4819-157-2-201207170-00459.
citation: Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014 Jan 28;(1):CD001431. doi: 10.1002/14651858.CD001431.pub4.