Laryngeal CarcinomaQoL in LSSCNCT07320820
Quality of Life and Functional Outcomes in Laryngeal Cancer Patients
An observational study of Laryngeal Carcinoma and Quality of Life (QOL), run by Saglik Bilimleri Universitesi.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngeal Carcinoma, Quality of Life (QOL), Patient Satisfaction
- What is being tested?
- Quality of Life Assessment, Patient Satisfaction Assessment and Swallowing Function Assessment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 2 Apr 2026to 31 Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients diagnosed with laryngeal squamous cell carcinoma who are planned to undergo surgical treatment, radiotherapy, or chemoradiotherapy.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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:
Read more
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
- Laryngeal Carcinoma, Quality of Life (QOL), Patient Satisfaction, Voice Quality, Swallowing Function, Pain Management
- Being tested
- Quality of Life Assessment, Patient Satisfaction Assessment, Swallowing Function Assessment, Voice Assessment, Pain Assessment
- Medical subject headings
- Laryngeal Neoplasms, Patient Satisfaction, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life AssessmentOther
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 AssessmentOther
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 AssessmentOther
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 AssessmentOther
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 AssessmentOther
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 AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Quality of Life Assessment; Other: Patient Satisfaction Assessment; Other: Swallowing Function Assessment; Other: Voice Assessment; Other: Pain Assessment; Other: Anxiety and Depression Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Baseline, 3 months, 6 months, and 12 months after completion of treatment.
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.
Measured: Baseline, 3 months, 6 months, and 12 months after completion of treatment.
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.
Measured: 3 months, 6 months, and 12 months after completion of treatment.
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.
Measured: Baseline, 3 months, 6 months, and 12 months after completion of treatment.
Change in Voice-Related Handicap (Voice Handicap Index-10 - VHI-10)
Change in patient-perceived voice handicap measured by the Voice Handicap Index-10 (VHI-10). Higher scores indicate greater perceived voice-related disability.
Measured: Baseline, 3 months, 6 months, and 12 months after completion of treatment.
Change in Pain Intensity (Visual Analog Scale - VAS)
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.
Measured: Baseline, 3 months, 6 months, and 12 months after completion of treatment.
Change in Anxiety and Depression Levels (Hospital Anxiety and Depression Scale - HADS)
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.
Measured: Baseline, 3 months, 6 months, and 12 months after completion of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start2 Apr 2026 (estimated)
- Primary completion2 Jan 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sumeyra DOLUOGLU, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320820
- Sponsor's protocol ID
- SaglikBUniversity
- Other IDs
- Ankara Etlik City Hospital
- Acronym
- QoL in LSSC
- Status last verified
- Apr 2026
- First submitted
- 13 Dec 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07320820
- Acronym / sponsor ID
- QoL in LSSC / SaglikBUniversity
- Conditions
- Laryngeal Carcinoma, Quality of Life (QOL), Patient Satisfaction, Voice Quality, Swallowing Function, Pain Management
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 2 Apr 2026 (estimated)
- Primary completion
- 2 Jan 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Surgical Treatment Group | – | Other: Quality of Life Assessment, Other: Patient Satisfaction Assessment, Other: Swallowing Function Assessment, Other: Voice Assessment, Other: Pain Assessment, Other: Anxiety and Depression AssessmentThis 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. |
| Radiotherapy Group | – | Other: Quality of Life Assessment, Other: Patient Satisfaction Assessment, Other: Swallowing Function Assessment, Other: Voice Assessment, Other: Pain Assessment, Other: Anxiety and Depression AssessmentThis 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. |
| Chemoradiotherapy Group | – | Other: Quality of Life Assessment, Other: Patient Satisfaction Assessment, Other: Swallowing Function Assessment, Other: Voice Assessment, Other: Pain Assessment, Other: Anxiety and Depression AssessmentThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients diagnosed with laryngeal squamous cell carcinoma who are planned to undergo surgical treatment, radiotherapy, or chemoradiotherapy.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of Life AssessmentQuality 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 | Chemoradiotherapy Group, Radiotherapy Group, Surgical Treatment Group |
| Patient Satisfaction AssessmentPatient 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 | Chemoradiotherapy Group, Radiotherapy Group, Surgical Treatment Group |
| Swallowing Function AssessmentSwallowing 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 | Chemoradiotherapy Group, Radiotherapy Group, Surgical Treatment Group |
| Voice AssessmentVoice-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 | Chemoradiotherapy Group, Radiotherapy Group, Surgical Treatment Group |
| Pain AssessmentPain 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 | Chemoradiotherapy Group, Radiotherapy Group, Surgical Treatment Group |
| Anxiety and Depression AssessmentPsychological 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. | Other | Chemoradiotherapy Group, Radiotherapy Group, Surgical Treatment Group |
Primary outcome
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.
7 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngeal Carcinoma and Quality of Life (QOL), run by Saglik Bilimleri Universitesi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.