The Efficacy of Decision Support E-book for Prostate Biopsy Decision Making
Condition: Prostate-Specific Antigen
Study type: Interventional

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.
    

Intervention name(s): Using an E-Book
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: prostate biopsy; E-Book; decision support intervention; decision self-efficacy; decision conflict