Quality of Life and Functional Outcomes in Laryngeal Cancer Patients

Official title

Assessment of Quality of Life, Patient Satisfaction, Swallowing Function, Voice Outcomes, Pain, and Anxiety-Depression at Baseline and at 3-, 6-, and 12-Month Follow-Up in Patients Diagnosed With Laryngeal Squamous Cell Carcinoma: A Prospective Questionnaire-Based Study

Overview

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.

Interventions

• Other Quality of Life Assessment
  Quality 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.
• Other Patient Satisfaction Assessment
  Patient 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.
• Other Swallowing Function Assessment
  Swallowing 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.
• Other Voice Assessment
  Voice-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.
• Other Pain Assessment
  Pain 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.
• Other Anxiety and Depression Assessment
  Psychological 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.

Primary outcome measures

• Change in Head and Neck-Specific Quality of Life (EORTC QLQ-H&N35) [Time frame: Baseline (pre-treatment), 3 months, 6 months, and 12 months after completion of treatment. Type of Measure: Patient-reported outcome; continuous scale.]

Secondary outcome measures (7)

• Change in Global Quality of Life (EORTC QLQ-C30) [Time frame: Baseline, 3 months, 6 months, and 12 months after completion of treatment.]
• Change in Swallowing Function (MD Anderson Dysphagia Inventory - MDADI) [Time frame: Baseline, 3 months, 6 months, and 12 months after completion of treatment.]
• Change in Patient Satisfaction (EORTC PATSAT-C33) [Time frame: 3 months, 6 months, and 12 months after completion of treatment.]
• Change in Dysphagia Severity (Eating Assessment Tool - EAT-10) [Time frame: Baseline, 3 months, 6 months, and 12 months after completion of treatment.]
• Change in Voice-Related Handicap (Voice Handicap Index-10 - VHI-10) [Time frame: Baseline, 3 months, 6 months, and 12 months after completion of treatment.]
• Change in Pain Intensity (Visual Analog Scale - VAS) [Time frame: Baseline, 3 months, 6 months, and 12 months after completion of treatment.]
• Change in Anxiety and Depression Levels (Hospital Anxiety and Depression Scale - HADS) [Time frame: Baseline, 3 months, 6 months, and 12 months after completion of treatment.]

Eligibility criteria

Inclusion criteria

• 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.
• No history of psychiatric or neurological disorders that could impair comprehension, questionnaire completion, or study participation.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07320820 · SaglikBUniversity · Ankara Etlik City Hospital

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗