Oral Health Related Quality of Life in Head and Neck Cancer Survivors Within the First Year Following Treatment

NCT06730139 | Completed

• 1 other identifier: MAM00213
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Oral Health-Related Quality of Life in Head and Neck Cancer Patients Problem Statement: Head and Neck Cancer (HNC) is a significant global health issue, and its incidence is rising. While treatment options have improved, they often lead to severe oral complications, impacting patients' quality of life. Research Gap: Limited research exists on oral health-related quality of life (OHRQoL) among HNC patients in Egypt, particularly focusing on the impact of oral clinical parameters and treatment-related factors. Research Objective: To assess the OHRQoL of HNC patients who have completed treatment within the past 12 months and to identify factors associated with impaired OHRQoL. Methodology: This study will employ a comprehensive approach to evaluate OHRQoL, considering: Oral Clinical Parameters: Oral hygiene status, oral mucositis, and other oral health indicators. Sociodemographic Factors: Age, gender, education, occupation, and socioeconomic status. Treatment-Related Variables: Type of treatment (surgery, radiation therapy, chemotherapy), treatment duration, and dose intensity. Expected Outcomes: The findings of this study will: Quantify the impact of HNC treatment on OHRQoL. Identify key factors associated with impaired OHRQoL. Highlight the importance of standardized oral care for HNC patients. Provide evidence-based recommendations for improving oral health support and enhancing the overall quality of life for HNC survivors. By addressing the oral health needs of HNC patients, this research aims to improve their quality of life and contribute to better long-term outcomes.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer (HNC); Oral Health-Related Quality of Life (OHRQoL); Radiation Therapy (RT); Oral Complications; Quality of Life

Outcome Measures

Primary Outcomes (1)

• European Organization for Treatment of Cancer Quality of Life Questionnaire for Head and Neck Cancer (EORTC QLQ-H&N-35).

  EORTC QLQ-H\&N-35 Minimum Score: 0 Maximum Score: 100 Higher Scores: Indicate worse outcomes and more severe symptoms. Domains Evaluated: Functional Domains: Pain and soreness in the mouth and throat Swallowing difficulties Taste and smell alterations Social eating and enjoyment of meals Social contact Sexuality Symptom Scale: Teeth problems Mouth opening difficulties Dry mouth Sticky saliva Coughing Feeling ill Pain killer use Nutritional supplement or feeding tube use Weight loss Weight gain

  Assessed once during the study (day 1 of the study)

Study Arms (1)

Head and Neck Cancer (HNC) Survivors

Target Population: Age: 18 years and older Diagnosis: Head and Neck Cancer (HNC) Treatment Status: Within the first year post-treatment completion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of HNC survivors who meet the following criteria: Age: 18 years and older Treatment Completion: Within the past year Dental Status: Presence of at least one molar and one central incisor in the upper and lower jaw Cognitive Function: No cognitive disabilities or debilitating conditions Mouth Opening: Minimum of 20 mm Participants will be recruited from the oncology unit at Ahmed Maher Teaching Hospital (AMTH) during their routine follow-up visits. Eligible patients will be informed about the study and provided with a written informed consent form.

You may qualify if:

• Age 18 years and above
• Diagnosed with HNC
• Within the first year post-cancer treatment
• Scheduled for a routine follow-up visit at AMTH
• Presence of at least one molar and one central incisor in each jaw
• Able to provide informed consent

You may not qualify if:

• Inability to provide informed consent
• Debilitative conditions or cognitive disabilities
• Trismus (mouth opening \< 20 mm)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ahmed Maher teaching hospital

Cairo, 11565, Egypt

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of Oral Medicine, Periodontology, and Oral Diagnosis, Faculty of Dentistry, King Salman International University, El-tor, Egypt.

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 12, 2024
• Study Start: December 20, 2023
• Primary Completion: August 20, 2024
• Study Completion: November 30, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)