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

NCT03633214 | Unknown

• 1 other identifier: BK070-2016
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer Screening

Keywords

Prostatic neoplasms; Mass screening; General practitioners; Primary health care; Clinical trial

Outcome Measures

Primary Outcomes (1)

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

  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.

  Through study completion, an average of 6 months

Secondary Outcomes (1)

• Post-online training module knowledge in prostate cancer screening

  An average of 6 months

Study Arms (2)

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

Other: Online training module

No training module (Control)

NO INTERVENTION

Interventions

Online training module OTHER

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.

Training module (Intervention)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• GPs who do not see male patients

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Department of Primary Care Medicine, University of Malaya Medical Centre

Kuala Lumpur, Lembah Pantai, 59100, Malaysia

Location

Related Publications (2)

• Schroder FH, Hugosson J, Roobol MJ, Tammela TL, Ciatto S, Nelen V, Kwiatkowski M, Lujan M, Lilja H, Zappa M, Denis LJ, Recker F, Paez A, Maattanen L, Bangma CH, Aus G, Carlsson S, Villers A, Rebillard X, van der Kwast T, Kujala PM, Blijenberg BG, Stenman UH, Huber A, Taari K, Hakama M, Moss SM, de Koning HJ, Auvinen A; ERSPC Investigators. Prostate-cancer mortality at 11 years of follow-up. N Engl J Med. 2012 Mar 15;366(11):981-90. doi: 10.1056/NEJMoa1113135.

  PMID: 22417251 BACKGROUND

• Andriole GL, Crawford ED, Grubb RL 3rd, Buys SS, Chia D, Church TR, Fouad MN, Gelmann EP, Kvale PA, Reding DJ, Weissfeld JL, Yokochi LA, O'Brien B, Clapp JD, Rathmell JM, Riley TL, Hayes RB, Kramer BS, Izmirlian G, Miller AB, Pinsky PF, Prorok PC, Gohagan JK, Berg CD; PLCO Project Team. Mortality results from a randomized prostate-cancer screening trial. N Engl J Med. 2009 Mar 26;360(13):1310-9. doi: 10.1056/NEJMoa0810696. Epub 2009 Mar 18.

  PMID: 19297565 BACKGROUND

Related Links

• Cancer Incidence and Mortality Worldwide: IARC CancerBase

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Tun Firzara Abdul Malik

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 16, 2018
• Study Start: July 25, 2018
• Primary Completion: April 15, 2019
• Study Completion: June 25, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

MY (1)