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

NCT03881709 | Completed

• 1 other identifier: (667)107A-39
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

prostate biopsy; E-Book; decision support intervention; decision self-efficacy; decision conflict

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

The intervention group

EXPERIMENTAL

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.

Behavioral: Using an E-Book

The control group

NO INTERVENTION

The control group will receive a health education about prostate biopsy.

Interventions

Using an E-Book BEHAVIORAL

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 intervention group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged between 40-80
• PSA greater than 4.0 ng/mL
• the transrectal ultrasound-guided prostate biopsy suggested by a physician
• able to communicate in Mandarin or Taiwanese.

You may not qualify if:

• had been diagnosed with prostate cancer
• had been diagnosed with psychiatric diseases
• with cognition impairments

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead
• Cheng-Hsin General Hospital: collaborator

Study Sites (1)

Cheng Hsin General Hospital

Taipei, 112, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 28543737 BACKGROUND

• 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.

  PMID: 26860126 BACKGROUND

• 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.

  PMID: 28012755 BACKGROUND

• 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.

  PMID: 29699543 BACKGROUND

Study Officials

• Tsae Jyy Wang, PhD

  National Taipei University of Nursing and Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN PhD Professor

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 19, 2019
• Study Start: January 4, 2019
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2019
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)