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

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ClinicalTrials.gov Identifier: NCT03881709
Recruitment Status : Completed
First Posted : March 19, 2019
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
Cheng-Hsin General Hospital
Information provided by (Responsible Party):
Tsae Jyy, Wang, National Taipei University of Nursing and Health Sciences

Tracking Information
First Submitted Date  ICMJE March 14, 2019
First Posted Date  ICMJE March 19, 2019
Last Update Posted Date April 17, 2019
Actual Study Start Date  ICMJE January 4, 2019
Actual Primary Completion Date March 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
  • 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.
  • 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].
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03881709 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Decision Support E-book for Prostate Biopsy Decision Making
Official Title  ICMJE The Efficacy of Decision Support E-book for Reducing Decisional Conflict on Prostate Biopsy Decision Making in Patients With Elevated Prostate-specific Antigen
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Condition  ICMJE Prostate-Specific Antigen
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Using an E-Book
  • No Intervention: The control group
    The control group will receive a health education about prostate biopsy.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2019)
110
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 30, 2019
Actual Primary Completion Date March 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03881709
Other Study ID Numbers  ICMJE (667)107A-39
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tsae Jyy, Wang, National Taipei University of Nursing and Health Sciences
Study Sponsor  ICMJE National Taipei University of Nursing and Health Sciences
Collaborators  ICMJE Cheng-Hsin General Hospital
Investigators  ICMJE
Principal Investigator: Tsae Jyy Wang, PhD National Taipei University of Nursing and Health Sciences
PRS Account National Taipei University of Nursing and Health Sciences
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP