About this trial
Laryngeal squamous cell carcinomas are head and neck malignancies that directly affect both swallowing and voice functions and are associated with a significant deterioration in patients' quality of life throughout the treatment process.
The aim of this study is to evaluate quality of life, voice and swallowing functions, pain, anxiety-depression levels, and patient satisfaction at the pre-treatment period and at the 3rd, 6th, and 12th months post-treatment in patients with laryngeal malignancies, using validated questionnaires, in order to:
Elucidate the course of functional recovery following treatment,
Individualize rehabilitation and follow-up strategies, and
Examine the relationship between functional outcomes and oncological survival.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years at the time of enrollment.
Histopathologically confirmed diagnosis of laryngeal squamous cell carcinoma.
Planned to undergo surgical treatment or radiotherapy/chemoradiotherapy as part of standard oncological care.
Willing and able to participate in the study and to provide written informed consent.
Disqualifiers
Age < 18 years.
Presence of comorbid conditions that may independently affect swallowing or voice functions.
Patients who withdraw consent or request to discontinue participation during or after the treatment period.
History of psychiatric disorders or use of psychiatric medications that may interfere with study participation or completion of patient-reported outcome measures.
Trial population
The study population consists of patients diagnosed with laryngeal squamous cell carcinoma who are planned to undergo surgical treatment, radiotherapy, or chemoradiotherapy.
Trial design
Cohort
Prospective
Treatments tested in this trial
Quality of Life Assessment
Other interventionQuality of life will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) and the Head and Neck Cancer-Specific Module (QLQ-H\&N35). The QLQ-C30 evaluates global health status, functional domains, and symptom scales, while the QLQ-H\&N35 provides disease-specific information related to head and neck cancer, including symptoms associated with swallowing, speech, pain, and social eating.
Patient Satisfaction Assessment
Other interventionPatient satisfaction with cancer care will be evaluated using the EORTC In-Patient Satisfaction with Care Questionnaire (PATSAT-C33). This instrument assesses patients' perceptions of the quality of care, communication with healthcare professionals, and overall satisfaction with treatment and supportive care services.
Swallowing Function Assessment
Other interventionSwallowing function will be assessed using the MD Anderson Dysphagia Inventory (MDADI) and the Eating Assessment Tool-10 (EAT-10). The MDADI is a disease-specific, patient-reported outcome measure that evaluates the impact of dysphagia on quality of life across emotional, functional, and physical domains. The EAT-10 is a symptom-specific screening tool designed to quantify the severity of swallowing difficulties and their effect on daily activities.
Voice Assessment
Other interventionVoice-related outcomes will be evaluated using the Voice Handicap Index-10 (VHI-10), a validated patient-reported questionnaire that measures the perceived impact of voice disorders on functional, physical, and emotional aspects of daily life.
Pain Assessment
Other interventionPain intensity will be assessed using the Visual Analog Scale (VAS), a widely used, validated tool that allows patients to rate their pain severity on a continuous scale, providing a quantitative measure of pain perception over time.
Anxiety and Depression Assessment
Other interventionPsychological status will be evaluated using the Hospital Anxiety and Depression Scale (HADS), a validated self-report instrument designed to assess symptoms of anxiety and depression in medically ill populations, minimizing the influence of somatic symptoms related to physical illness.
Treatment groups
Trial outcomes
Primary outcomes
Change in Head and Neck-Specific Quality of Life (EORTC QLQ-H&N35)
Change in head and neck cancer-specific quality of life as assessed by the EORTC QLQ-H\&N35 questionnaire. The instrument evaluates symptoms and functional impairments related to head and neck cancer and its treatment; higher scores indicate greater symptom burden and worse quality of life.
Secondary outcomes
Change in Global Quality of Life (EORTC QLQ-C30)
Change in global health status/quality of life score measured by the EORTC QLQ-C30 questionnaire. Higher scores on the global health status scale indicate better overall quality of life.
Change in Swallowing Function (MD Anderson Dysphagia Inventory - MDADI)
Change in swallowing-related quality of life assessed by the MD Anderson Dysphagia Inventory (MDADI). Higher scores indicate better perceived swallowing function and quality of life.
Change in Patient Satisfaction (EORTC PATSAT-C33)
Change in patient satisfaction with cancer care measured using the EORTC PATSAT-C33 questionnaire, which assesses satisfaction with physicians, nurses, organization of care, and overall treatment experience. Higher scores indicate greater patient satisfaction.
Change in Dysphagia Severity (Eating Assessment Tool - EAT-10)
Change in dysphagia symptom severity measured by the Eating Assessment Tool-10 (EAT-10). Higher scores indicate more severe swallowing difficulties.
Locations
Sponsors and contacts
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