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

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

Sponsors

Lead sponsor: National Taipei University of Nursing and Health Sciences

Collaborator: Cheng-Hsin General Hospital

Source 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.

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.

Overall Status Completed
Start Date January 4, 2019
Completion Date March 30, 2019
Primary Completion Date March 30, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Prostate Biopsy Knowledge Scale 1 hour after pre-test
Decision Self-Efficacy Scale 1 hour after pre-test
Decisional Conflict Scale 1 hour after pre-test
Enrollment 110
Condition
Intervention

Intervention type: Behavioral

Intervention name: Using an E-Book

Description: 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.

Arm group label: The intervention group

Eligibility

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

Gender: Male

Minimum age: 40 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Tsae Jyy Wang, PhD Principal Investigator National Taipei University of Nursing and Health Sciences
Location
facility Cheng Hsin General Hospital
Location Countries

Taiwan

Verification Date

April 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: National Taipei University of Nursing and Health Sciences

Investigator full name: Tsae Jyy, Wang

Investigator title: RN PhD Professor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: The intervention group

Arm group type: Experimental

Description: 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.

Arm group label: The control group

Arm group type: No Intervention

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Double (Participant, Care Provider)

Source: ClinicalTrials.gov