Oral Health-Related Quality of Life Using EORTC QLQ-H&N35 in Head and Neck Cancer Survivors Withi… (NCT06901401) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
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
Egypt112 participantsStarted 2024-10-15
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Oral Health-Related Quality of Life (OHRQoL) Score