The investigators will obtain three-monthly voice recordings and fiberendoscopic examinations of the larynx/hypopharynx for a minimal period of 6 months from all laryngeal/hypopharyngeal squamous cell carcinoma (LSCC/HPSCC) patients, who have successfully completed curative primary treatment, except those who underwent total laryngectomy. Furthermore, the investigators will ask the patients to fill out the voice handicap index-30 questionnaire (VHI-30) during each study visit. The VHI-30 allows to make a subjective assessment of the patients' own vocal problem. The primary objective is to assess the feasibility and compliance of longterm regular voice monitoring in LSCC and HPSCC follow-up.
Study Type
OBSERVATIONAL
Enrollment
100
The following speech samples will be recorded from the study participants: * Standardized, phonetically balanced text * Sustained, modulated production of five vowels * Picture description * Diadochokinetic exercise. Before starting speech recording, the participant fills in a questionnaire consisting of: * Health barometer * Self-rating in terms of stress/fatigue/emotional status. An Ear, Nose and Throat examination incl. transnasal fiberendoscopy is performed at each visit. The investigators will assess the vocal folds/aryepiglottic folds for the presence of paralysis or reduced mobility, as well as the presence of scar/synechia, edema, erythro-/leukoplakia, or a cancer-suspicious lesion/mass in the larynx/hypopharynx or a chondroradionecrosis in the larynx. Additionally, it will be assessed, if a tracheotomy canula or a nasogastric tube is in place or was used since the last visit. Furthermore, the investigators will ask the patients to fill out the VHI-30.
Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Inselspital, Bern University Hospital
Bern, Switzerland
RECRUITINGDepartment of Oto-Rhino-Larnygology, Head and Neck Surgery, University Hospital Zurich
Zurich, Switzerland
RECRUITINGPatients' compliance with scheduled 3-monthly endoscopic exam, voice recordings, and filling out of questionnaire
The number of completed visits/exams out of all scheduled visits/exams.
Time frame: 3-21 months
Recruitment rate
Recruitment rate (number of enrolled participants per year).
Time frame: 0-21 months
Subjective changes in voice
Subjective changes in voice assessed by the voice handicap index-30 (VHI-30).
Time frame: 0-21 months
Objective changes in voice 1
Changes in Roughness - Breathiness - Hoarseness (RBH).
Time frame: 0-21 months
Objective changes in voice 2
Changes in Jitter and Shimmer (JS).
Time frame: 0-21 months
Objective changes in voice 3
Changes in Glottal-to-Noise Excitation Ratio (GNE).
Time frame: 0-21 months
Objective changes in voice 4
Changes in Singing Power Ratio (SPR).
Time frame: 0-21 months
Recurrences of the index tumor
Number/Percentage of patients with biopsy-proven local, regional, and/or systemic recurrences of the initially treated LSCC/HPSCC. Note: In special scenarios such as co-morbidities, patient's rejection or other medical conditions, a biopsy can be omitted if there is a consensus for a recurrence at the multidisciplinary tumor board based on the clinical and/or radiologic findings.
Time frame: 0-21 months
Recurrences in other localizations
Number/Percentage of patients with biopsy-proven local, regional, and/or systemic recurrences in other localizations. Note: In special scenarios such as co-morbidities, patient's rejection or other medical conditions, a biopsy can be omitted if there is a consensus for a recurrence at the multidisciplinary tumor board based on the clinical and/or radiologic findings.
Time frame: 0-21 months
Second primary malignancies in the larynx/hypopharynx
Number/Percentage of patients with biopsy-proven local, regional, and/or systemic second primary malignancy in the larynx/hypopharynx. Note: In special scenarios such as co-morbidities, patient's rejection or other medical conditions, a biopsy can be omitted if there is a consensus for a second primary malignancy at the multidisciplinary tumor board based on the clinical and/or radiologic findings.
Time frame: 0-21 months
Second primary malignancies in other localizations
Number/Percentage of patients with biopsy-proven local, regional, and/or systemic second primary malignancy in other localizations. Note: In special scenarios such as co-morbidities, patient's rejection or other medical conditions, a biopsy can be omitted if there is a consensus for a second primary malignancy at the multidisciplinary tumor board based on the clinical and/or radiologic findings.
Time frame: 0-21 months
Composite of clinical events
Composite endpoint: Number/Percentage of patients with laryngeal/hypopharyngeal recurrence, second primary malignancy, edema, scar/synechia, erythro-/leukoplakia, laryngeal chondroradionecrosis and hypomobility/ paralysis determined by fiber-endoscopy.
Time frame: 0-21 months
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