Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-01-04 @ 3:41 AM
Study NCT ID:
NCT06684067
Status:
COMPLETED
Last Update Posted:
2024-11-12
First Post:
2024-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Patient Navigation on Colonoscopy Completion Screening Rate for Colorectal Cancer.
Sponsor:
University of Malaya
Organization:
Study Overview
Official Title:
A Prospective Randomized Controlled Trial to Evaluate the Effect of Patient Navigation on Colonoscopy Screening Rate for Colorectal Cancer (CRC) in University Malaya Medical Centre (UMMC)
Status:
COMPLETED
Status Verified Date:
2024-10
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:
The goal of this randomized controlled trial is to evaluate the effectiveness of patient navigation on colonoscopy completion rates in a population screened for colorectal cancer. The main question\[s\] it aims to answer are:
Are colonoscopy completion rates in colorectal cancer screening increased in navigated (intervention arm) compared with non-navigated (control arm) participants?
Is mental well-being, as measured by HADs and GHQ12 scores, better in the intervention arm compared with the control arm?
Participants in the intervention arm will receive:
* standard clinic instructions for the colonoscopy
* phone calls from the patient navigator to discuss the purpose, preparation, and additional information regarding the colonoscopy procedure
* a webpage QR code consist of information on visual image on colonoscopy preparation and procedures, layout and map guidance to navigate in the hospital
* a direct line for phone calls to patient navigators for further guidance on overcoming barriers
Participants in the control arm will only receive:
* standard clinic instructions for the colonoscopy
* one phone call from the patient navigator to discuss the colonoscopy procedure
Are colonoscopy completion rates in colorectal cancer screening increased in navigated (intervention arm) compared with non-navigated (control arm) participants?
Is mental well-being, as measured by HADs and GHQ12 scores, better in the intervention arm compared with the control arm?
Participants in the intervention arm will receive:
* standard clinic instructions for the colonoscopy
* phone calls from the patient navigator to discuss the purpose, preparation, and additional information regarding the colonoscopy procedure
* a webpage QR code consist of information on visual image on colonoscopy preparation and procedures, layout and map guidance to navigate in the hospital
* a direct line for phone calls to patient navigators for further guidance on overcoming barriers
Participants in the control arm will only receive:
* standard clinic instructions for the colonoscopy
* one phone call from the patient navigator to discuss the colonoscopy procedure
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: