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Clinical Trials/NCT03633214
NCT03633214UnknownNot Applicable

Evaluation of An Online Intervention In Improving General Practitioners' Practice In Prostate Cancer Screening

University of Malaya1 site in 1 country96 target enrollmentStarted: July 25, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
96
Locations
1
Primary Endpoint
Evaluation of effectiveness of online training module among general practitioners in prostate cancer screening

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Investigator)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Full time general practitioners in the Klang valley (Petaling district and Kuala Lumpur)

Exclusion Criteria

  • •GPs who do not see male patients

Arms & Interventions

Training module (Intervention)

Active Comparator

Responses of GPs in the intervention group will then be compared before and immediately after the online training video and also 3-months later

Intervention: Online training module (Other)

No training module (Control)

No Intervention

Outcomes

Primary Outcomes

Evaluation of effectiveness of online training module among general practitioners in prostate cancer screening

Time Frame: Through study completion, an average of 6 months

Difference in the change in proportions of appropriate prostate cancer screening from baseline by GPs between intervention (online training module) and control (no online training module) groups.

Secondary Outcomes

  • Post-online training module knowledge in prostate cancer screening(An average of 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr Tun Firzara Abdul Malik

Principal Investigator

University of Malaya

Study Sites (1)

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