Ignite Creation Date:
2024-05-06 @ 1:44 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01886547
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2013-06-23
Brief Title:
2013 Annual National Digital Rectal Exam DRE Day Study
Sponsor:
St Lukes Medical Center Philippines
Organization:
St Lukes Medical Center Philippines
Study Overview
Official Title:
2013 Annual National Digital Rectal Exam DRE Day Impact on Prostate Health Awareness and Disease Detection
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We aim to determine the effectiveness of 2013 Mag paDRE ka programme in increasing general public awareness on prostate health and promoting prostate health assessment among Filipino males aged 40 or older
Detailed Description:
Convenience sampling method will be applied to collect all completed Philippine Urological Association PUA survey forms from the 11 Philippine Board of Urology accredited training institutions A data collection form for the purpose of this study will be used to extract data from the Philippine Urological Association survey forms The data collection form for this study will extract data which include basic demographic characteristics of the patients such as age and educational attainment family history of prostate cancer other medical conditions history of prior prostate screening consultation for Lower urinary tract Symptoms or prostate disease The International Prostate Symptom scores IPSS collected will be stratified according to mild 1-7 moderate 8-19 and severe 20-35 and the Filipino version Quality of Life QoL ratings will be stratified according to Grade 1 grade 2 and grade 3 DRE findings including the approximation of prostate size and prostate characteristic findings will be clustered to normal in size 20grams or less versus enlarged 20grams or 2 fingerbreadths in width nodular vs non-nodular doughy or hard and tender versus non-tender
Participants will be classified according to the following
1 Target population for screening or not
Target population for screening is defined as Filipino males aged 40 years or older who also had no previous consultation for Lower urinary tract symptoms LUTS or prostate cancer screening in the past 12 months
2 Case Finding for significant LUTS or prostate cancer or not
Case of LUTS or prostate cancer is defined as Filipino males aged 40 years or older with IPSS 8 OR has abnormal Digital rectal exam DRE finding which is defined as nodular OR hard OR tender However DRE finding of an enlarged prostate but non-nodular doughy in character and non-tender will not be considered as a case of LUTS or prostate cancer suspect
Confidentiality of all data will be assured The case report forms data collection form for this study will not contain any patient identifiers All patient records will be coded in the electronic database as serial number and PUA-designated Institutional code ie SLMC 0001 Only the investigators of this study and other authorized personnel from PUA will be given access to the study data The PUA survey forms will be secured filed and only accessed in PUA secretariat building The electronic database coded with the data from the data collection from of this study will be set with password and only the study investigators have access to the password
Participants will be classified according to the following
1 Target population for screening or not
Target population for screening is defined as Filipino males aged 40 years or older who also had no previous consultation for Lower urinary tract symptoms LUTS or prostate cancer screening in the past 12 months
2 Case Finding for significant LUTS or prostate cancer or not
Case of LUTS or prostate cancer is defined as Filipino males aged 40 years or older with IPSS 8 OR has abnormal Digital rectal exam DRE finding which is defined as nodular OR hard OR tender However DRE finding of an enlarged prostate but non-nodular doughy in character and non-tender will not be considered as a case of LUTS or prostate cancer suspect
Confidentiality of all data will be assured The case report forms data collection form for this study will not contain any patient identifiers All patient records will be coded in the electronic database as serial number and PUA-designated Institutional code ie SLMC 0001 Only the investigators of this study and other authorized personnel from PUA will be given access to the study data The PUA survey forms will be secured filed and only accessed in PUA secretariat building The electronic database coded with the data from the data collection from of this study will be set with password and only the study investigators have access to the password
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None