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NCT03881709
The Efficacy of Decision Support E-book for Prostate Biopsy Decision Making
NA trial testing Using an E-Book in Prostate-Specific Antigen in 110 participants. Completed in 30 March 2019.
30 March 2019
Quick facts
| Lead sponsor | National Taipei University of Nursing and Health Sciences |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 110 |
| Start date | 4 January 2019 |
| Primary completion | 30 March 2019 |
| Estimated completion | 30 March 2019 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- Using an E-Book
Conditions studied
- Prostate-Specific Antigen — all drugs for Prostate-Specific Antigen →
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.
Verify or expand the search:
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03881709 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Taipei University of Nursing and Health Sciences
- Last refreshed: 17 April 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03881709.
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