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
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.
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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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05187949 -
Promoting Shared-decision Making in Opportunistic Screening for Prostate Cancer
|
||
| Recruiting |
NCT03968692 -
Adequacy of Prostate-Specific Antigen (PSA) Requests
|