Prostate Cancer Screening Clinical Trial
Official title:
Evaluation of An Online Intervention In Improving General Practitioners' Practice In Prostate Cancer Screening
The incidence of prostate cancer has been rising steadily both globally and in Malaysia.
Besides an ageing population, another reason cited to explain the increase, is the
corresponding increase in the prostate cancer screening rates, especially using non-invasive
tests like the prostate specific antigen (PSA).
General practitioners, being front liners in medicine, play an important role in helping men
make an informed decision on prostate cancer screening. In Malaysia, about 50% of GPs would
routinely screen asymptomatic men and 95% of them would use PSA as a screening tool. Despite
this, the evidence for screening is inconclusive, as evidenced from two major trials on
screening [The European Randomised Study of Screening for Prostate Cancer (ERSPC) and
Prostate, Lung, Colorectal and Ovarian Cancer Screening trial (PLCO)]. Furthermore, clinical
practice guidelines globally provide conflicting recommendations on this subject, and none
has been published in Malaysia to date.
Therefore, our study aims to determine the effectiveness of an online training module in
helping GPs' better understand the controversies surrounding prostate cancer screening, and
in so doing, improve their practice of screening. The investigators hypothesise that GPs who
are randomised to receive their online module will be less inclined to screen unnecessarily
for prostate cancer.
Study design: Randomised controlled trial
Setting: This trial will involve GPs in the Klang Valley, encompassing the Petaling district
and Kuala Lumpur.
The healthcare system in Malaysia is divided into public and private sectors. Patients pay a
standard minimal fee for public healthcare system whereas the private sector charges patients
based on the services provided. The study will be conducted in private GP clinics as PSA
testing is readily available compared to the public primary care setting. In public primary
care clinics, PSA screening is not offered as part of a routine screening programme.
Sample size:
With 80% power and 5% (two-sided) significance, with an estimated 40% reduction in PSA
screening from baseline in the intervention group and 10% in the control group, the number of
participants needed for each group is 38 (total 76). Therefore, a total of 96 GPs in the
Klang Valley will be recruited for this study, assuming a non-response rate of 20 GPs.
Intervention:
The intervention consists of two phases.
Phase 1 The research team will develop 3 self-administered, online surveys, with the input of
family physicians and urologists. The surveys will capture basic demographic information
about the participating GPs (but not any identifiable information), and also their overall
knowledge and perception towards prostate cancer screening. In addition, all 3 surveys will
also contain 5 clinical vignettes that will relate to prostate cancer screening. After
reading the vignettes, the GPs will be asked whether or not they would recommend screening
for the particular patient in the given scenario; and should they choose to screen, which
screening method they would use (PSA, DRE, or both).
GPs will then be randomised to either receive an online training module (intervention) or
none (control).
Phase 2:
Upon successful receipt of the GPs' response to the first survey, a second survey will be
sent to all the GPs via email. The participants will once again be invited to read and
respond to another set of vignettes of similar nature to those in phase 1.
GPs who have been randomised to the intervention arm will also receive a link in the second
email that will enable them to download an online training module. The participants will be
asked to view the training module prior to answering the second survey.
GPs in the control group will only receive the second survey and not the training module.
A third and final email will be sent to all the GPs who have successfully answered the second
survey, 3 months after the date of receipt of their second survey response. This final survey
will likewise, contain five clinical vignettes of similar nature to those of the two previous
surveys. The responses of GPs in the intervention group will then be compared before and
immediately after the online training video and also 3-months later; as well as to the
control group.
Recruitment:
The research team will recruit the GPs from an existing GP database which has been created
from previous studies conducted in the Petaling District and Kuala Lumpur. A researcher and a
research assistant will be responsible for identifying and recruiting eligible participants.
An invitation letter, a study summary, a participant information sheet and consent form will
be sent via email to each GP. Consenting participants will be remunerated for their time and
effort spent in participating in the study. In the event response is poor, a research
assistant may need to arrange an appointment to visit the GPs at their clinics'.
Analysis:
The McNemar test will be used to determine the phase differences in the proportion of GPs who
perform screening unnecessarily and the differences between the intervention and control
group. Chi square test will be used to compare the difference in proportions between the
intervention and control groups. GPs' characteristics associated with unnecessary screening
practice will be explored using logistic regression models using phase 1 data. Logistic
regression will be used for binary outcomes and the analyses will be adjusted for baseline
data. SPSS will be used to manage the data sets
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