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

Paris Diderot University

Status: Completed

Conditions: Prostate Cancer

Treatments: Other: Decision aid

Study type: Interventional

Funder types: Other

Identifiers

NCT02156869

DMG1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,170 patients

Sex: Male

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,170 participants in 2 patient groups

Intervention arm

Experimental group

Description:

The intervention was the use of a decision aid.

Treatment:

Other: Decision aid

Control arm

No Intervention group

Description:

Usual care