Head and Neck Cancers, Laryngeal Carcinoma
Conditions
Keywords
head and neck cancer, follow-up, patient satisfaction, telemedicine, patient reported outcome measures, quality of life
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
Interventions
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
Sponsors
Isala
Saxenburgh Group
University Medical Center Groningen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease specific and overall survival | 12 months | Safety: survival |
| Patient satisfaction | 12 months | 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. |
| Local and regional recurrence rate | 12 months | Safety is measured by addressing local and regional recurrence rate |
| Postoperative complications after recurrence | 12 months | Safety: postoperative complications after recurrence |
| Re-referral to the head and neck oncology center | 12 months | Safety: re-referral rates to the oncology center |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of visits to the hospital | 12 months | Amount of hospital visits |
| Traveling time and distance | 12 months | Travel time in hours and minutes, distance in kilometres |
| HRQoL | 12 months | In addition, the following outcome measures will be assessed: health related quality-of-life (HRQoL) using the ED-5D-5L questionnaire |
| Symptom burden | 12 months | Using specific questions from the EORTC QLQ - H&N35 questionnaire |
| Fear of disease recurrence | 12 months | Using the Cancer Worry scale |
Countries
Netherlands
Contacts
Primary ContactNathalie F van Rhee, MD
Outcome results
None listed