Clinical trial · Observational
Oral Health-Related Quality of Life Using EORTC QLQ-H&N35 in Head and Neck Cancer Survivors Within the First Year Following Treatment: a Cross-Sectional Study in Egypt
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to evaluate Oral Health-Related Quality of Life (OHRQoL) in head and neck cancer (HNC) survivors within the first year following treatment in Egypt. Using a cross-sectional study design, data will be collected from patients at Ahmed Maher Teaching Hospital (AMTH) through structured questionnaires and clinical assessments, including the Arabic version of EORTC QLQ-H\&N35, oral hygiene index-simplified (OHI-S), and the WHO Oral Mucositis Scale. The study will examine the association between OHRQoL and various factors, including sociodemographic characteristics, oral hygiene practices, and clinical parameters such as oral mucositis severity. A sample size of 112 participants was determined using a one-sample t-test, ensuring adequate statistical power while accounting for a 20% dropout rate. Findings from this research will help highlight the impact of HNC treatment on oral health and provide insights into improving oral care strategies for better patient quality of life in Egypt.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cncer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- HNC Survivors' Oral Health and Quality of Life in Egypt
- description
- This cohort includes head and neck cancer (HNC) survivors within the first year post-treatment at Ahmed Maher Teaching Hospital (AMTH) in Egypt. The study evaluates Oral Health-Related Quality of Life (OHRQoL) using the EORTC QLQ-H\&N35 questionnaire, along with clinical assessments like the Oral Hygiene Index-Simplified (OHI-S) and the WHO Oral Mucositis Scale. The research examines the impact of sociodemographic factors, oral hygiene practices, and treatment-related variables on oral health and overall quality of life, with a focus on radiotherapy and chemotherapy effects. While no interventions are applied, findings will support future strategies to improve post-treatment oral care for HNC survivors in Egypt.
Primary outcomes (1)
- measure
- Oral Health-Related Quality of Life (OHRQoL) Score
- timeFrame
- single point "Baseline"
- description
- The Oral Health-Related Quality of Life (OHRQoL) Score will be assessed using the EORTC QLQ-H\&N35 questionnaire, a validated tool for evaluating the impact of head and neck cancer (HNC) and its treatment on patients' oral health and overall quality of life. This questionnaire captures functional, social, and psychological aspects related to oral health, including pain, swallowing difficulties, dry mouth, speech problems, and social interactions. Scores range from 0 to 100, with higher scores indicating worse OHRQoL and greater impairment in daily activities. This measure will help identify factors influencing post-treatment oral health outcomes and guide future supportive care strategies for HNC survivors in Egypt
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: (HNC). * Completed cancer treatment (surgery, radiotherapy, and/or chemotherapy) within the past 12 months. * Attending routine follow-up visits at Ahmed Maher Teaching Hospital (AMTH), Egypt. * Able to communicate and complete the EORTC QLQ-H\&N35 questionnaire. * Presence of at least one molar and one central incisor in both upper and lower dentition (for oral hygiene assessment). * Provided written informed consent to participate in the study. Exclusion Criteria: * Patients with cognitive impairment or severe mental illness affecting their ability to respond to the questionnaire. * Patients with debilitating conditions (e.g., terminal illness, bedridden status). * Trismus (mouth opening \<20mm) preventing oral examination. * Patients who decline to participate or withdraw consent. * Patients with incomplete medical records or loss to follow-up.
References
Publications (1)
- DERIVEDHassanein FEA, Abou-Bakr A, William H, Ahmed Y, Ibrahim SS. Oral health-related quality of life in head and neck cancer survivors in Egypt within the first year after radiotherapy: a multivariable analysis. BMC Oral Health. 2025 Dec 27;26(1):181. doi: 10.1186/s12903-025-07488-9. PMID 41454361