Prostate Cancer ScreeningProCaSSNCT03633214
Evaluation of An Online Intervention In Improving General Practitioners' Practice In Prostate Cancer Screening
A study testing Online training module in people with Prostate Cancer Screening, run by University of Malaya at 1 site in Malaysia.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer Screening
- What is being tested?
- Online training module
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteMalaysia
- Study dates
- 25 Jul 2018to 25 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Full time general practitioners in the Klang valley (Petaling district and Kuala Lumpur)
Who cannot join
- GPs who do not see male patients
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Department of Primary Care Medicine, University of Malaya Medical Centre
Kuala Lumpur, Lembah Pantai, 59100
About this study
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.
Read the 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
- Conditions
- Prostate Cancer Screening
- Being tested
- Online training module
- Keywords
- Prostatic neoplasms, Mass screening, General practitioners, Primary health care, Clinical trial
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online training moduleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Online training module |
| No training module (Control) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 6 months
Secondary outcomes (1)
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
Measured: An average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start25 Jul 2018
- Primary completion15 Apr 2019
- Study completion25 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Tun Firzara Abdul Malik, University of Malaya
- Investigators
- Tun Firzara Abdul Malik, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633214
- Sponsor's protocol ID
- BK070-2016
- Acronym
- ProCaSS
- Status last verified
- Apr 2019
- First submitted
- 1 Aug 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
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.
PubMed 22417251Andriole 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.
PubMed 19297565
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of An Online Intervention In Improving General Practitioners' Practice In Prostate Cancer Screening
- ClinicalTrials.gov ID
- NCT03633214
- Acronym / sponsor ID
- ProCaSS / BK070-2016
- Conditions
- Prostate Cancer Screening
- Keywords
- Prostatic neoplasms, Mass screening, General practitioners, Primary health care, Clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 25 Jun 2019 (estimated)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training module (Intervention) | Active comparator | Other: Online training moduleResponses of GPs in the intervention group will then be compared before and immediately after the online training video and also 3-months later |
| No training module (Control) | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Full time general practitioners in the Klang valley (Petaling district and Kuala Lumpur)
Key exclusion criteria (1 listed)
- GPs who do not see male patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online training moduleResponses 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. | Other | Training module (Intervention) |
Primary outcome
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.
1 secondary outcome
Post-online training module knowledge in prostate cancer screening
Time frame: An average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Background: PubMed 22417251Schroder 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.
- Background: PubMed 19297565Andriole 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.
- Cancer Incidence and Mortality Worldwide: IARC CancerBaseLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tun Firzara Abdul Malik principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online training module in people with Prostate Cancer Screening, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of effectiveness of online training module among general practitioners in prostate cancer screening (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03633214, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019; AzTrials last refreshed its copy on 27 Oct 2026.