NCT03881709|Completed
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Sponsor study identifier
interventional
110
1 country
1
Study Start
January 4, 2019
Actual (reported)Primary Completion
March 30, 2019
Actual (reported)Study Completion
March 30, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 30, 2019
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 4, 2019
Actual (reported)March 14, 2019
Actual (reported)March 19, 2019
Actual (reported)March 30, 2019
Actual (reported)March 30, 2019
Actual (reported)Prostate Biopsy Knowledge Scale
The scale measures patient's knowledge of prostate biopsy. There are 16 items in the scale. Each item is rated on dichotomy. The possible score for the scale ranges from 0 to 16. The higher values represent more knowledge of prostate biopsy patient have.
1 hour after pre-test
Decision Self-Efficacy Scale
There are 11 items in the scale. Each item is rated on a 5-point Likert scale from 0(not confident) to 4(a lot confident). The mean of 11 items multiplied by 25 represent the total score. The possible of the total score for the scale ranges from 0 \[not confident\] to 100 \[extremely confident\].
1 hour after pre-test
Decisional Conflict Scale
There are 16 items in the scale. Each item is rated on a 5-point Likert scale from 0(strongly agree) to 4(strongly disagree). The mean of 16 items multiplied by 25 represent the total score. The possible of the total score for the scale ranges from 0 \[no decisional conflict\] to 100 \[extremely high decisional conflict\]. Scores exceeding 37.5 are associated with decision delay.
1 hour after pre-test
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Cheng Hsin General Hospital
Taipei, 112, Taiwan
Chen NH, Lin YP, Liang SY, Tung HH, Tsay SL, Wang TJ. Conflict when making decisions about dialysis modality. J Clin Nurs. 2018 Jan;27(1-2):e138-e146. doi: 10.1111/jocn.13890. Epub 2017 Jul 17.
Luque JS, Ross L, Gwede CK. Prostate Cancer Education in African American Barbershops: Baseline Client Survey Results and Differences in Decisional Conflict and Stage of Decision Making. Am J Mens Health. 2016 Nov;10(6):533-536. doi: 10.1177/1557988316630952. Epub 2016 Feb 9.
Tsae Jyy Wang, PhD
National Taipei University of Nursing and Health Sciences
110 participants (actual enrollment reported by the registry).
First Submitted
March 14, 2019
First Posted
March 19, 2019
Study Start
January 4, 2019
Actual (reported)A Cluster Package Intervention to Promote an Evidence-based Use of PSA-tests in General Practice
Contact the study team to confirm eligibility.
Catalona WJ, Richie JP, Ahmann FR, Hudson MA, Scardino PT, Flanigan RC, DeKernion JB, Ratliff TL, Kavoussi LR, Dalkin BL, Waters WB, MacFarlane MT, Southwick PC. Comparison of Digital Rectal Examination and Serum Prostate Specific Antigen in the Early Detection of Prostate Cancer: Results of a Multicenter Clinical Trial of 6,630 Men. J Urol. 2017 Feb;197(2S):S200-S207. doi: 10.1016/j.juro.2016.10.073. Epub 2016 Dec 22.
Groarke A, Curtis R, Walsh DMJ, Sullivan FJ. What predicts emotional response in men awaiting prostate biopsy? BMC Urol. 2018 Apr 24;18(1):27. doi: 10.1186/s12894-018-0340-9.
Primary Completion
March 30, 2019
Actual (reported)Study Completion
March 30, 2019
Actual (reported)Last Updated
April 17, 2019
Record last verified: 2019-04
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