Quality of Life and Functional Outcomes in Laryngeal Cancer Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSaglik Bilimleri Universitesi

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Quality of Life Assessment

    Other intervention

    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 intervention

    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 intervention

    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 intervention

    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 intervention

    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 intervention

    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.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Surgical Treatment Group6 interventions
Group B: Radiotherapy Group6 interventions
Group C: Chemoradiotherapy Group6 interventions

Trial outcomes

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.

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 outcomes

1

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.

Time frame
Baseline, 3 months, 6 months, and 12 months after completion of treatment.
2

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.

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

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.

Time frame
3 months, 6 months, and 12 months after completion of treatment.
4

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.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: