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

April 16, 2019 updated by: Tsae Jyy, Wang, National Taipei University of Nursing and Health Sciences

The Efficacy of Decision Support E-book for Reducing Decisional Conflict on Prostate Biopsy Decision Making in Patients With Elevated Prostate-specific Antigen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prostate-specific antigen (PSA) is the primary screening test for prostate cancer. The elevated PSA test result is usually followed by the transrectal ultrasound-guided prostate biopsy (TRUS-Bx) for further diagnosis. However, patients often have lots concerns while deciding whether or not to undergo a prostate biopsy. They may worry about the biopsy associated complications such as urinary tract infection, pain, hematuria, bloody stools, etc., causing damage to urinary tract or sexual function, diagnosed with prostate cancer, or cancer spreading. Some may even worry about that a cancer cell can be transmitted to a partner through sexual activity after a biopsy. All these can cause physiological stress and decisional conflict for the patients. Therefore, it is necessary to provide decision support measures in order to improve the patients' knowledge regarding the advantages and disadvantages of prostate biopsy, to increase their decision self-efficacy, and to decrease their decisional conflict, thereby to achieve the share decision making goal. However, few studies have examined the efficacy of decision aids on prostate biopsy decision making. Therefore, the purpose of 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.

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. The study instruments include the prostate biopsy knowledge scale, the Decision Self-Efficacy Scale, and the Decisional Conflict Scale. Data on whether the patients received a prostate biopsy will also be collected from the patients' medical records.

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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • Cheng Hsin General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. had been diagnosed with prostate cancer
  2. had been diagnosed with psychiatric diseases
  3. with cognition impairments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The intervention 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.
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.
No Intervention: The control group
The control group will receive a health education about prostate biopsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prostate Biopsy Knowledge Scale
Time Frame: 1 hour after pre-test
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
Time Frame: 1 hour after pre-test
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
Time Frame: 1 hour after pre-test
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taipei University of Nursing and Health Sciences

Collaborators

Cheng-Hsin General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2019

Primary Completion (Actual)

March 30, 2019

Study Completion (Actual)

March 30, 2019

Study Registration Dates

First Submitted

March 14, 2019

First Submitted That Met QC Criteria

March 18, 2019

First Posted (Actual)

March 19, 2019

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • (667)107A-39

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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