Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT06940505
Status:
RECRUITING
Last Update Posted:
2025-08-19
First Post:
2025-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telemedicine Follow-Up for Early Laryngeal Cancer: a Randomized Controlled Trial Comparing Care Close to Home Versus Standard of Care
Sponsor:
University Medical Center Groningen
Organization:
Study Overview
Official Title:
Telemedicine Follow-up for Pre-malignant and Malignant Glottic Lesions: a Randomised Controlled Trial Study Protocol Comparing Care Close to Home Versus Standard of Care
Status:
RECRUITING
Status Verified Date:
2025-04
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:
Telemedicine
Brief Summary:
The goal of this clinical trial is to evaluate whether Telemedicine follow-up is a satisfactory and safe alternative to traditional follow-up care for patients treated for early glottic (vocal cord) cancer, particularly those who live far from a specialized head and neck oncology centre (HNOC).
The main questions it aims to answer are:
Is patient satisfaction with Telemedicine follow-up comparable to standard care?
Is the safety of Telemedicine follow-up (measured by recurrence rates, complications, and survival) comparable to in-person follow-up at an HNOC?
Researchers will compare patients receiving Telemedicine follow-up in a nearby hospital with standard in-person follow-up at the HNOC, to see if remote evaluation of endoscopic procedures can maintain patient satisfaction and safety outcomes.
Participants with a travel time of \> 45 minutes from a HNOC will:
Be randomly assigned to either a Telemedicine follow-up group (in a nearby hospital, by a general ENT-surgeon) or a standard of care group
Undergo follow-up including HD-laryngoscopy, according to clinical guidelines
Have endoscopy videos evaluated remotely by specialists at the HNOC (= Telemedicine) (intervention group only)
Complete surveys including patient-reported outcomes and experience measures at baseline, 6 months, and 12 months
The main questions it aims to answer are:
Is patient satisfaction with Telemedicine follow-up comparable to standard care?
Is the safety of Telemedicine follow-up (measured by recurrence rates, complications, and survival) comparable to in-person follow-up at an HNOC?
Researchers will compare patients receiving Telemedicine follow-up in a nearby hospital with standard in-person follow-up at the HNOC, to see if remote evaluation of endoscopic procedures can maintain patient satisfaction and safety outcomes.
Participants with a travel time of \> 45 minutes from a HNOC will:
Be randomly assigned to either a Telemedicine follow-up group (in a nearby hospital, by a general ENT-surgeon) or a standard of care group
Undergo follow-up including HD-laryngoscopy, according to clinical guidelines
Have endoscopy videos evaluated remotely by specialists at the HNOC (= Telemedicine) (intervention group only)
Complete surveys including patient-reported outcomes and experience measures at baseline, 6 months, and 12 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: