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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

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.


Condition or disease Intervention/treatment Phase
Prostate-Specific Antigen Behavioral: Using an E-Book Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: The Efficacy of Decision Support E-book for Reducing Decisional Conflict on Prostate Biopsy Decision Making in Patients With Elevated Prostate-specific Antigen
Actual Study Start Date : January 4, 2019
Actual Primary Completion Date : March 30, 2019
Actual Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.

  2. 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].

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881709


Locations
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Taiwan
Cheng Hsin General Hospital
Taipei, Taiwan, 112
Sponsors and Collaborators
National Taipei University of Nursing and Health Sciences
Cheng-Hsin General Hospital
Investigators
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Principal Investigator: Tsae Jyy Wang, PhD National Taipei University of Nursing and Health Sciences

Publications:
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Responsible Party: Tsae Jyy, Wang, RN PhD Professor, National Taipei University of Nursing and Health Sciences
ClinicalTrials.gov Identifier: NCT03881709     History of Changes
Other Study ID Numbers: (667)107A-39
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tsae Jyy, Wang, National Taipei University of Nursing and Health Sciences:
prostate biopsy
E-Book
decision support intervention
decision self-efficacy
decision conflict