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NCT03881709

The Efficacy of Decision Support E-book for Prostate Biopsy Decision Making

Completed NA Last updated 17 April 2019
What this trial tests

NA trial testing Using an E-Book in Prostate-Specific Antigen in 110 participants. Completed in 30 March 2019.

Timeline
4 January 2019
Primary endpoint
30 March 2019
30 March 2019

Quick facts

Lead sponsorNational Taipei University of Nursing and Health Sciences
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposesupportive care
Enrollment110
Start date4 January 2019
Primary completion30 March 2019
Estimated completion30 March 2019
Sites1 location across Taiwan

Drugs / interventions tested

Conditions studied

Sponsor

National Taipei University of Nursing and Health Sciences

Who can join

Adults 40 to 80, male only, with Prostate-Specific Antigen. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

PURPOSE: This study is to test the efficacy of decision support E-Book for 1) increasing prostate biopsy knowledge and decision self-efficacy, and 2) reducing decisional conflict on prostate biopsy decision making in patients with elevated serum PSA. DESIGN: The study is based on an experimental design. A convent sample of 110 adult males with a PSA greater than 4.0 ng/mL and the transrectal ultrasound-guided prostate biopsy suggested by a physician will be recruited from the urology clinics. Patients will be randomly assigned to the intervention and control group. The intervention group will receive the biopsy decision support intervention delivered by a nurse using an E-Book containing a comprehensive information about prostate biopsy. The control group will receive a health education about prostate biopsy. Data on biopsy knowledge, decision self-efficacy and decision conflict will be collected at pre and post test by using the study questionnaires. ANALYSIS: Independent sample t -tests and chi-square tests will be used to compare the between group baseline equilibrium. Independent sample t -tests will be also used to analyze the between group differences in biopsy knowledge, decision self-efficacy, and decision conflict at post-test to evaluate the efficacy of the decision support intervention.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Trials by the same sponsor.

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