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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Change in Head and Neck-Specific Quality of Life (EORTC QLQ-H&N35)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Quality of Life Assessment (Other)
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.
干预措施: Patient Satisfaction Assessment (Other)
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.
干预措施: Swallowing Function Assessment (Other)
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.
干预措施: Pain Assessment (Other)
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.
干预措施: Anxiety and Depression Assessment (Other)
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.
干预措施: Quality of Life Assessment (Other)
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.
干预措施: Patient Satisfaction Assessment (Other)
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.
干预措施: Swallowing Function Assessment (Other)
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.
干预措施: Voice Assessment (Other)
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.
干预措施: Pain Assessment (Other)
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.
干预措施: Anxiety and Depression Assessment (Other)
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.
干预措施: Quality of Life Assessment (Other)
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.
干预措施: Swallowing Function Assessment (Other)
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.
干预措施: Voice Assessment (Other)
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.
干预措施: Pain Assessment (Other)
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.
干预措施: Anxiety and Depression Assessment (Other)
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.
干预措施: Voice Assessment (Other)
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.
干预措施: Patient Satisfaction Assessment (Other)
结局指标
主要结局
Change in Head and Neck-Specific Quality of Life (EORTC QLQ-H&N35)
时间窗: 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.
次要结局
- Change in Global Quality of Life (EORTC QLQ-C30)(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 Swallowing Function (MD Anderson Dysphagia Inventory - MDADI)(Baseline, 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.)
- Change in Pain Intensity (Visual Analog Scale - VAS)(Baseline, 3 months, 6 months, and 12 months after completion of treatment.)
- Change in Anxiety and Depression Levels (Hospital Anxiety and Depression Scale - HADS)(Baseline, 3 months, 6 months, and 12 months after completion of treatment.)
研究者
Sumeyra DOLUOGLU
Associate Professor
Saglik Bilimleri Universitesi