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| Name | Class |
|---|---|
| Isala | OTHER |
| Saxenburgh Group | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine Group - Intervention | Experimental | Participants in the intervention group will receive follow-up care at a general hospital located nearby their residence. They will have a travel time reduction of ≥ 40%. During these visits, a general otolaryngologist will perform guideline-based follow-up evaluations, including high-definition laryngoscopy. The recorded endoscopic videos will be securely transferred and remotely evaluated by specialists at the Head and Neck Oncology Centre (HNOC) via Telemedicine. This collaborative model allows for specialist oversight without requiring the patient to travel long distances, aiming to maintain high standards of care while improving accessibility and convenience. |
|
| Control group | No Intervention | Participants in the control group (standard of care) will receive their follow-up care directly at the Head and Neck Oncology Centre (HNOC), in accordance with national guidelines. Follow-up visits will include in-person evaluations by a specialized head and neck oncologist, including high-definition laryngoscopy performed and interpreted on-site. This group represents the current standard practice for follow-up care in the Netherlands and serves as the control (long travel time) for evaluating patient satisfaction and safety in comparison to the Telemedicine model. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine Follow-up | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Our primary outcomes are satisfaction with care and travel distance. Satisfaction is reported on a 0-10 numerical rating scale (NRS) and will be compared between study groups at baseline and 6 months and 12 months post-inclusion. | 12 months |
| Patient satisfaction | Specific questions from the Consumer Quality Index (CQI) questionnaires are used for assessing patient satisfaction | 12 months |
| Local and regional recurrence rate | Safety is measured by addressing local and regional recurrence rate | 12 months |
| Postoperative complications after recurrence | Safety: postoperative complications after recurrence | 12 months |
| Re-referral to the head and neck oncology center | Safety: re-referral rates to the oncology center | 12 months |
| Disease specific and overall survival | Safety: survival | 12 months |
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| Measure | Description | Time Frame |
|---|---|---|
| HRQoL | In addition, the following outcome measures will be assessed: health related quality-of-life (HRQoL) using the ED-5D-5L questionnaire | 12 months |
| Symptom burden | Using specific questions from the EORTC QLQ - H&N35 questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathalie F van Rhee, MD | Contact | +31614915058 | n.f.van.rhee@umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| Boudewijn E.C. Plaat, MD, PhD | UMC Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Recruiting | Groningen | Provincie Groningen | 9713GZ | Netherlands |
Participants will not provide explicit consent for their data to be shared beyond the scope of the current study
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| 12 months |
| Fear of disease recurrence | Using the Cancer Worry scale | 12 months |
| Traveling time and distance | Travel time in hours and minutes, distance in kilometres | 12 months |
| Number of visits to the hospital | Amount of hospital visits | 12 months |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D007822 | Laryngeal Neoplasms |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D010038 | Otorhinolaryngologic Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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