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

NCT03881709 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2019-04-17

No results posted yet for this study

Summary

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.

Conditions

  • Prostate-Specific Antigen

Interventions

BEHAVIORAL

Using an E-Book

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.

Sponsors & Collaborators

  • Cheng-Hsin General Hospital

    collaborator OTHER
  • National Taipei University of Nursing and Health Sciences

    lead OTHER

Principal Investigators

  • Tsae Jyy Wang, PhD · National Taipei University of Nursing and Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-04
Primary Completion
2019-03-30
Completion
2019-03-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03881709 on ClinicalTrials.gov