Prostate Cancer Clinical Trial
Official title:
Impact of a Printed Decision Aid on Patients' Intent to Undertake Prostate Cancer Screening: a Multicenter Pragmatic Randomized Controlled Trial
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.
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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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
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