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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Head and Neck Cncer

Detailed Description

Head and neck cancer (HNC) is the seventh most common cancer globally, accounting for more than 660,000 new cases and 325,000 deaths annually. The number of HNC cases is expected to grow by 30% each year until 2030.[1] The rise has been observed in both developed and developing countries.[2] The survival for HNC has improved modestly over the past three decades with the introduction of different and multi-disciplinary treatment modalities.[3] There are several treatment options for HNC, including radiation therapy, surgery, and chemotherapy. These treatments can be used alone or in combination. Radiation therapy (RT) involves using high-energy beams to destroy cancer cells, while it is an important part of HNC treatment, it can also cause various toxicities, sometimes severe, toxicities.[4].

In most of the cases, head and neck tumors may destroy organs that play an important part in daily activities such as eating and speaking [5]. Additionally, the therapeutic approaches for the treatment of cancer usually result in collateral effects [6]. that impact in the quality of life. The assessment of the quality of life in patients with cancer became a valuable tool to investigate the progression of the disease and the effectiveness of the treatment [7].

The oral condition has an essential role in the individual's systemic health [8]. In specific, the quality of lifer elated to oral health (OHRQoL) may be defined as the lack of negative impact of the oral condition on social, psychological and functional activities [9]. In general, patients with tumors in the oral cavity figure amongst the worst indices for the quality of life when compared to patients with tumors in other regions [10]. Based on the exposed, the present study aimed to measure the impact of OHRQoL of patients with HNC and to evaluate the factors associated.

QoL assessment is an important tool for evaluating not only the impact of disease and its treatment on an individual level but also helpful in developing and revising the rehabilitative ser- vices and patient education material to further improve the clinical outcomes (survival) of patients [11]. Oral health related quality of life (OHRQoL), specifically focuses on self-report aspects pertaining to oral health, capturing the functional, social, and psychological dimensions affected by oral disease [12]. In the case of HNC, disruptions in key oral functions poses a higher risk of adversely affecting both OHRQoL and overall QoL[13].

Not much evidence is found in Egypt related to oral care measures for HNC patients, such as professional care by a dentist and dental hygienist (mechanical or manual removal of mucosal debris, oral hygiene counsel- ling, etc.) at least once a week until the completion of RT [14]. The patients are often unaware of the potential harm from the cancer treatment, only a proportion of HNC patients seek dental consultation for their complications, and most of them suffer greatly even after the completion of treatment due to disturbed oral functions.

To the best of our knowledge, this study represents the first comprehensive assessment of OHRQoL in HNC treated patients who had completed their cancer treatment within the past 12 months. Additionally, it aims to explore the associations between various oral clinical parameters, including oral hygiene status and oral mucositis, and several predictive factors such as sociodemographic characteristics and treatment-related variables in relation to OHRQoL. The findings of this study will highlights the importance of standardizing oral care and improving oral health support for HNC treated patients to reduce the impact of oral problems which can negatively impact their overall quality of life.

• Study Type: Observational
• Enrollment (Estimated): 112

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ahmed Maher Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will include adult head and neck cancer (HNC) survivors who have completed surgery, radiotherapy, and/or chemotherapy within the past 12 months. Participants will be recruited from the oncology unit at Ahmed Maher Teaching Hospital (AMTH) in Egypt during their routine follow-up visits.

The study population will consist of individuals aged 18 years and older, representing diverse sociodemographic backgrounds. Eligibility criteria include patients who can communicate and complete the EORTC QLQ-H&N35 questionnaire, as well as those with at least one molar and one central incisor in both upper and lower dentition for oral hygiene assessment. Patients with cognitive impairments, severe debilitating conditions, or trismus (mouth opening <20mm) will be excluded.

This study aims to evaluate the impact of cancer treatment on oral health-related quality of life (OHRQoL) and identify factors affecting post-treatment oral health outcomes in Egyptian HNC survivors.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

HNC Survivors' Oral Health and Quality of Life in Egypt; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Health-Related Quality of Life (OHRQoL) Score	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	single point "Baseline"

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Estimated): April 15, 2025
• Study Completion (Estimated): April 15, 2025

Study Registration Dates

• First Submitted: March 23, 2025
• First Submitted That Met QC Criteria: March 23, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 23, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Oral Health-Related Quality of Life (OHRQoL); Head and Neck Cancer (HNC); EORTC QLQ-H&N35
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: HAM00213

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No