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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D007822', 'term': 'Laryngeal Neoplasms'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2025-04-07', 'studyFirstSubmitQcDate': '2025-04-15', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'HRQoL', 'timeFrame': '12 months', 'description': 'In addition, the following outcome measures will be assessed: health related quality-of-life (HRQoL) using the ED-5D-5L questionnaire'}, {'measure': 'Symptom burden', 'timeFrame': '12 months', 'description': 'Using specific questions from the EORTC QLQ - H\\&N35 questionnaire'}, {'measure': 'Fear of disease recurrence', 'timeFrame': '12 months', 'description': 'Using the Cancer Worry scale'}, {'measure': 'Traveling time and distance', 'timeFrame': '12 months', 'description': 'Travel time in hours and minutes, distance in kilometres'}, {'measure': 'Number of visits to the hospital', 'timeFrame': '12 months', 'description': 'Amount of hospital visits'}], 'primaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': '12 months', 'description': '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.'}, {'measure': 'Patient satisfaction', 'timeFrame': '12 months', 'description': 'Specific questions from the Consumer Quality Index (CQI) questionnaires are used for assessing patient satisfaction'}, {'measure': 'Local and regional recurrence rate', 'timeFrame': '12 months', 'description': 'Safety is measured by addressing local and regional recurrence rate'}, {'measure': 'Postoperative complications after recurrence', 'timeFrame': '12 months', 'description': 'Safety: postoperative complications after recurrence'}, {'measure': 'Re-referral to the head and neck oncology center', 'timeFrame': '12 months', 'description': 'Safety: re-referral rates to the oncology center'}, {'measure': 'Disease specific and overall survival', 'timeFrame': '12 months', 'description': 'Safety: survival'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['head and neck cancer', 'follow-up', 'patient satisfaction', 'telemedicine', 'patient reported outcome measures', 'quality of life'], 'conditions': ['Head and Neck Cancers', 'Laryngeal Carcinoma']}, 'descriptionModule': {'briefSummary': '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).\n\nThe main questions it aims to answer are:\n\nIs patient satisfaction with Telemedicine follow-up comparable to standard care?\n\nIs the safety of Telemedicine follow-up (measured by recurrence rates, complications, and survival) comparable to in-person follow-up at an HNOC?\n\nResearchers 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.\n\nParticipants with a travel time of \\> 45 minutes from a HNOC will:\n\nBe randomly assigned to either a Telemedicine follow-up group (in a nearby hospital, by a general ENT-surgeon) or a standard of care group\n\nUndergo follow-up including HD-laryngoscopy, according to clinical guidelines\n\nHave endoscopy videos evaluated remotely by specialists at the HNOC (= Telemedicine) (intervention group only)\n\nComplete surveys including patient-reported outcomes and experience measures at baseline, 6 months, and 12 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who underwent TOLS for early stage glottic squamous cell carcinoma (T1 or carcinoma-in-situ)\n* a one-way travel time to the HNOC of ≥45 minutes (intervention group) or \\< 30 minutes (control group)\n* within 2 years postoperatively\n* can speak and write Dutch\n\nExclusion Criteria:\n\n* Patients will be excluded if they continue to undergo follow-up for other (head and neck) cancers in the HNOC.'}, 'identificationModule': {'nctId': 'NCT06940505', 'acronym': 'Telemedicine', 'briefTitle': 'Telemedicine Follow-Up for Early Laryngeal Cancer: a Randomized Controlled Trial Comparing Care Close to Home Versus Standard of Care', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'M23.325004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telemedicine Group - Intervention', 'description': '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.', 'interventionNames': ['Other: Telemedicine Follow-up']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': '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.'}], 'interventions': [{'name': 'Telemedicine Follow-up', 'type': 'OTHER', 'description': "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", 'armGroupLabels': ['Telemedicine Group - Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9713GZ', 'city': 'Groningen', 'state': 'Provincie Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Nathalie F van Rhee, MD', 'role': 'CONTACT', 'email': 'n.f.van.rhee@umcg.nl', 'phone': '+31614915058'}], 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'centralContacts': [{'name': 'Nathalie F van Rhee, MD', 'role': 'CONTACT', 'email': 'n.f.van.rhee@umcg.nl', 'phone': '+31614915058'}], 'overallOfficials': [{'name': 'Boudewijn E.C. Plaat, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Groningen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Participants will not provide explicit consent for their data to be shared beyond the scope of the current study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Isala', 'class': 'OTHER'}, {'name': 'Saxenburgh Group', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}