Trials / Recruiting
RecruitingNCT06940505
Telemedicine Follow-Up for Early Laryngeal Cancer: a Randomized Controlled Trial Comparing Care Close to Home Versus Standard of Care
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- Sponsor
- University Medical Center Groningen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Telemedicine Follow-up | Oncological follow-up in a general hospital close to the patient, with aid of Telemedicine evaluation of the endoscopy video's by a Head and Neck surgeon in a specialised oncology centre |
Timeline
- Start date
- 2025-04-01
- Primary completion
- 2027-04-01
- Completion
- 2027-06-01
- First posted
- 2025-04-23
- Last updated
- 2025-08-19
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT06940505. Inclusion in this directory is not an endorsement.