Quality of Life and Functional Outcomes in Laryngeal Cancer Patients

NCT07320820 | Not Yet Recruiting

• 2 other identifiers: SaglikBUniversityAnkara Etlik City Hospital
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Voice Quality; Swallowing Function; Pain Management; Anxiety Depression; Laryngeal Carcinoma; Quality of Life (QOL); Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (pre-treatment), 3 months, 6 months, and 12 months after completion of treatment. Type of Measure: Patient-reported outcome; continuous scale.

Secondary Outcomes (7)

• Change in Global Quality of Life (EORTC QLQ-C30)

  Baseline, 3 months, 6 months, and 12 months after completion of treatment.

• Change in Swallowing Function (MD Anderson Dysphagia Inventory - MDADI)

  Baseline, 3 months, 6 months, and 12 months after completion of treatment.

• Change in Patient Satisfaction (EORTC PATSAT-C33)

  3 months, 6 months, and 12 months after completion of treatment.

• Change in Dysphagia Severity (Eating Assessment Tool - EAT-10)

  Baseline, 3 months, 6 months, and 12 months after completion of treatment.

• Change in Voice-Related Handicap (Voice Handicap Index-10 - VHI-10)

  Baseline, 3 months, 6 months, and 12 months after completion of treatment.

Study Arms (3)

Surgical Treatment Group

This group includes patients with laryngeal squamous cell carcinoma who undergo primary surgical treatment, such as partial or total laryngectomy, with or without neck dissection, in accordance with standard oncological indications. Patients in this group may receive adjuvant radiotherapy or chemoradiotherapy when clinically indicated based on pathological findings.

Other: Quality of Life Assessment; Other: Patient Satisfaction Assessment; Other: Swallowing Function Assessment; Other: Voice Assessment; Other: Pain Assessment; Other: Anxiety and Depression Assessment

Radiotherapy Group

This group consists of patients with laryngeal squamous cell carcinoma treated with definitive radiotherapy as the primary treatment modality. Radiotherapy is delivered according to established clinical protocols, and no surgical intervention to the primary tumor is performed as the initial treatment.

Other: Quality of Life Assessment; Other: Patient Satisfaction Assessment; Other: Swallowing Function Assessment; Other: Voice Assessment; Other: Pain Assessment; Other: Anxiety and Depression Assessment

Chemoradiotherapy Group

This group includes patients with laryngeal squamous cell carcinoma who receive concurrent chemoradiotherapy as the primary treatment modality, typically for organ preservation purposes or in locally advanced disease. Chemotherapy is administered concurrently with radiotherapy in accordance with institutional and international treatment guidelines.

Other: Quality of Life Assessment; Other: Patient Satisfaction Assessment; Other: Swallowing Function Assessment; Other: Voice Assessment; Other: Pain Assessment; Other: Anxiety and Depression Assessment

Interventions

Quality of Life Assessment OTHER

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.

Chemoradiotherapy Group; Radiotherapy Group; Surgical Treatment Group

Patient Satisfaction Assessment OTHER

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.

Chemoradiotherapy Group; Radiotherapy Group; Surgical Treatment Group

Swallowing Function Assessment OTHER

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.

Chemoradiotherapy Group; Radiotherapy Group; Surgical Treatment Group

Voice Assessment OTHER

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.

Chemoradiotherapy Group; Radiotherapy Group; Surgical Treatment Group

Pain Assessment OTHER

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.

Chemoradiotherapy Group; Radiotherapy Group; Surgical Treatment Group

Anxiety and Depression Assessment OTHER

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.

Chemoradiotherapy Group; Radiotherapy Group; Surgical Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients diagnosed with laryngeal squamous cell carcinoma who are planned to undergo surgical treatment, radiotherapy, or chemoradiotherapy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

MeSH Terms

Conditions

Laryngeal Neoplasms; Patient Satisfaction; Agnosia

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 13, 2025
• First Posted: January 6, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): January 2, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share