search
Back to results

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

Primary Purpose

Prostate Cancer Screening

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Online training module
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostate Cancer Screening focused on measuring Prostatic neoplasms, Mass screening, General practitioners, Primary health care, Clinical trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • GPs who do not see male patients

Sites / Locations

  • Department of Primary Care Medicine, University of Malaya Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Training module (Intervention)

No training module (Control)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Post-online training module knowledge in prostate cancer screening
Difference in the post-online training module knowledge and attitudes towards prostate cancer screening between the intervention and control groups. GPs' characteristics that are associated with prostate cancer screening

Full Information

First Posted
August 1, 2018
Last Updated
April 17, 2019
Sponsor
University of Malaya
search

1. Study Identification

Unique Protocol Identification Number
NCT03633214
Brief Title
Evaluation of An Online Intervention In Improving General Practitioners' Practice In Prostate Cancer Screening
Acronym
ProCaSS
Official Title
Evaluation of An Online Intervention In Improving General Practitioners' Practice In Prostate Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 25, 2018 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
June 25, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer Screening
Keywords
Prostatic neoplasms, Mass screening, General practitioners, Primary health care, Clinical trial

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Training module (Intervention)
Arm Type
Active Comparator
Arm Description
Responses of GPs in the intervention group will then be compared before and immediately after the online training video and also 3-months later
Arm Title
No training module (Control)
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Online training module
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of effectiveness of online training module among general practitioners in prostate cancer screening
Description
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.
Time Frame
Through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
Post-online training module knowledge in prostate cancer screening
Description
Difference in the post-online training module knowledge and attitudes towards prostate cancer screening between the intervention and control groups. GPs' characteristics that are associated with prostate cancer screening
Time Frame
An average of 6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Full time general practitioners in the Klang valley (Petaling district and Kuala Lumpur) Exclusion Criteria: GPs who do not see male patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tun Firzara Abdul Malik
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Primary Care Medicine, University of Malaya Medical Centre
City
Kuala Lumpur
State/Province
Lembah Pantai
ZIP/Postal Code
59100
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
It is not yet known if there will be a plan to make IPD available.
Citations:
PubMed Identifier
22417251
Citation
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. Erratum In: N Engl J Med. 2012 May 31;366(22):2137.
Results Reference
background
PubMed Identifier
19297565
Citation
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. Erratum In: N Engl J Med. 2009 Apr 23;360(17):1797.
Results Reference
background
Links:
URL
http://globocan.iarc.fr
Description
Cancer Incidence and Mortality Worldwide: IARC CancerBase

Learn more about this trial

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

We'll reach out to this number within 24 hrs