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

Prostate-Specific Antigen Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03881709
• Other study ID #: (667)107A-39
• Status: Completed
• Phase: N/A
• Start date: January 4, 2019
• Est. completion date: March 30, 2019

Study information

• Verified date: April 2019
• Source: National Taipei University of Nursing and Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate-Specific Antigen

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Cheng Hsin General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences	Cheng-Hsin General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2016 Feb 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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