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NCT Number: NCT07320820

Quality of Life and Functional Outcomes in Laryngeal Cancer Patients

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.

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Key information

Conditions

Laryngeal Carcinoma Agnosia Anxiety Depression Behavior Head and Neck Neoplasms Health Behavior Laryngeal Diseases Laryngeal Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pain Management Pathological Conditions, Signs and Symptoms Patient Satisfaction Perceptual Disorders Quality of Life (QOL) Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Swallowing Function Treatment Adherence and Compliance Voice Quality

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

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.

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.

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.

Primary outcomes

  1. 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.

    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

  1. 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 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.

  2. 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 swallowing-related quality of life assessed by the MD Anderson Dysphagia Inventory (MDADI). Higher scores indicate better perceived swallowing function and quality of life.

  3. Change in Patient Satisfaction (EORTC PATSAT-C33)

    Time frame: 3 months, 6 months, and 12 months after completion of treatment.

    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.

  4. 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 dysphagia symptom severity measured by the Eating Assessment Tool-10 (EAT-10). Higher scores indicate more severe swallowing difficulties.

  5. 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 patient-perceived voice handicap measured by the Voice Handicap Index-10 (VHI-10). Higher scores indicate greater perceived voice-related disability.

  6. Change in Pain Intensity (Visual Analog Scale - VAS)

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

    Change in pain intensity measured using a Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.

  7. 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.

    Change in anxiety and depression symptoms measured by the Hospital Anxiety and Depression Scale (HADS), including HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D) subscales. Higher scores indicate greater psychological distress.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study 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

Acronym: QoL in LSSC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 6, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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