NCT06940505 Telemedicine Follow-Up for Early Laryngeal Cancer: a Randomized Controlled Trial Comparing Care Close to Home Versus Standard of Care
| NCT ID | NCT06940505 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Groningen |
| Condition | Head and Neck Cancers |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2025-04-01 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
Inclusion Criteria: * patients who underwent TOLS for early stage glottic squamous cell carcinoma (T1 or carcinoma-in-situ) * a one-way travel time to the HNOC of ≥45 minutes (intervention group) or \< 30 minutes (control group) * within 2 years postoperatively * can speak and write Dutch Exclusion Criteria: * Patients will be excluded if they continue to undergo follow-up for other (head and neck) cancers in the HNOC.
Contact & Investigator
Boudewijn E.C. Plaat, MD, PhD
PRINCIPAL INVESTIGATOR
UMC Groningen
Frequently Asked Questions
Who can join the NCT06940505 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06940505 currently recruiting?
Yes, NCT06940505 is actively recruiting participants. Contact the research team at n.f.van.rhee@umcg.nl for enrollment information.
Where is the NCT06940505 trial being conducted?
This trial is being conducted at Groningen, Netherlands.
Who is sponsoring the NCT06940505 clinical trial?
NCT06940505 is sponsored by University Medical Center Groningen. The principal investigator is Boudewijn E.C. Plaat, MD, PhD at UMC Groningen. The trial plans to enroll 140 participants.
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