Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Neoplasms

Mouth and Tooth Diseases

Rare Diseases

Fibrosis

Lichen Planus

Mouth Neoplasms

Oral Submucous Fibrosis

Leukoplakia

Leukoplakia, Oral

Erythroplasia

Lip Neoplasms

Lichenoid Eruptions

Exanthema

Skin Diseases

Skin Diseases, Papulosquamous

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Precancerous Conditions

Pathological Conditions, Anatomical

Oral Cancer

Erythroplakia

Lip and Oral Cavity Cancer

Oral Leukoplakia

Proliferative Verrucous Leukoplakia

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

No intervention utilised

John Adeoye

Peter Thomson

This study will be conducted to obtain data on oral cancer risk factors to generate machine learning models with good predictive accuracy for stratifying individuals with high-oral cancer risk and delineating high-risk and low-risk oral lesions. Likewise, this study will seek to provide oral cancer-related health education and training on oral-self-examination for beneficiaries

Oral rinse samples obtained via drooling in 50cc tubes.

Oral Cancer Screening and Education in Hong Kong

THE HONG KONG ORAL CANCER EDUCATION AND SCREENING (HOCES) PROGRAM: REFINING DISEASE PREVENTION, RISK STRATIFICATION AND EARLY DETECTION

Predictive accuracy of the ML classifiers for forecasting individuals with or likely to develop high-risk lesions within 24 months of first screening encounter based on demographic and lifestyle information.

Predictive accuracy of ML classifiers for classifying high-risk and low-risk lesions based on demographic and lifestyle risk factors, oral high-risk HPV status, and salivary DNA hypermethylation levels.

The University of Hong Kong

Professor

Infections

Behaviors and Mental Disorders

Lichen Planus, Oral

Hyperplasia

Candidiasis

Carcinoma

Carcinoma in Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Quality of Life

Chronic Graft Versus Host Disease

INCLUSION CRITERIA

These include:

* Adults aged 18 or above at the time of the screening visit.
* Good command of English language both written and spoken \[this is necessary as questionnaires are in English and cannot be translated unless through a cross-cultural validation study\].
* Being able to consent.
* Diagnosed with OED as per current standard diagnostic criteria.
* No concurrent malignancy in the head and neck or elsewhere.

No intervention was/is planned for this study. The study is questionnaire-based (observational).

No intervention is planned for this study

Background: Oral epithelial dysplasia (OED) is a condition with an increased risk of oral cancer. Due to the current changes in the factors associated with these diseases (because of human papillomavirus), it is expected that those who have no history of smoking or alcohol, young (\<50 years old), and white male would be commonly affected. Those individuals require a higher need for information, preferred a more active role in decision-making, and have a longer lifespan than older individuals. There remain no detailed studies of whether the informational needs delivered to patients with OED met their needs or indeed what information such patient may wish. A few tools are available to evaluate the IN of patients with head and neck disorders. However, the items of these instruments were dedicated to a particular disease (e.g. cancer) and hence are not applicable to be used for OED.

Project aims: To evaluate the psychometric properties of the Oral Epithelial Dysplasia Informational Needs Questionnaire (ODIN-Q), developed and revised in the preliminary work for the proposed study, in a cohort of patients with OED.

Timescale: 19 months.

Clinical significance: This questionnaire can be useful in clinical practice. It could help to meet the patient's information needs and plan educational interventions for those showing unmet needs.

Oral epithelial dysplasia (OED) is a disease associated with an increased risk of oral cancer between 6% and 36% compared to disease-free individuals. In the United Kingdom, oral cancer is among the 15 most common cancers, with approximately 6,000 new cases per year and these numbers are expected to rise in the few coming years.

Research showed the importance of patient education and the provision of information in shared-decision making and management of chronic and cancer-linked disease such as perhaps OED. However, patients may not be satisfied with the information provided by healthcare professionals, despite the extensive nature of the information provided. Having unmet informational needs may associate with higher anxiety levels which in turn could affect the patient's well-being and cooperation with the treatment provided.

Avoiding these undesirable health outcomes requires the delivery of tailored and patient-centred care that provides information based on what patients truly need and prefer. One increasingly common method to do so is to obtain this information by informational needs questionnaires. These questionnaires have been developed for other medical conditions including chronic diseases and some cancers, but none of these is known to be appropriate to use for OED specifically. Hence, a specific tool to determine the informational needs and preferences of patients with OED may help to achieve these objectives effectively. The data collected by this tool may help to acknowledge the impact of the illness on physical and psychological well-being. Furthermore, this data could be used to produce a source of OED information (such as a patient information leaflet) that reflects the IN of this patient population.

In the preliminary work for this study, the Oral Epithelial Dysplasia Informational Needs Questionnaire (ODIN-Q) was developed by adopting existing valid and reliable instruments that explore the information need of patients with potentially malignant disease elsewhere in the body, using experts input. The questions were then formulated and tested for content validity by clinicians (n=12) and patients (n=5), with unclear, irrelevant, redundant, and unacceptable items omitted. The final 35-item ODIN-Q includes two scales: (1) amount of information already received (too much, enough, not enough and none) and (2) degree of importance of the information (very, yes, not very, not at all).

Thus, the objectives of this study are to (1) test the newly developed ODIN-Q in a cohort of patients with OED; (2) to investigate the correlations between patients' informational needs and both of psychological variables (e.g. anxiety and depression) and quality of life; and (3) to develop and a Patient Information Leaflet (PIL) for OED based on patients' needs and preferences.

Oral Epithelial Dysplasia Informational Needs Questionnaire

Development of an Oral Epithelial Dysplasia Informational Needs Questionnaire

To evaluate the psychometric properties of the Oral Epithelial Dysplasia Informational Needs Questionnaire (ODIN-Q), developed and revised in the preliminary work for the proposed study, in a cohort of patients with OED (Phase 1).

To investigate the correlation between psychological variables (e.g. anxiety and depression), quality of life (QoL) and information needs by analysis of the data collected by ODIN-Q, Krantz Health Opinion Survey, Hospital Anxiety and Depression Scale, Modified Dental Anxiety Scale and the Oral Health Impact Profile-14 (phase 1).

To develop and assess the satisfaction with a patient information leaflet \[PIL\] about OED (phase 2).

University College London Hospitals

University College, London

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Oral Cancer Screening and Education in Hong Kong	NCT04487938	Oral Cancer Oral Leukoplaki... Oral Submucous ... Proliferative V... Oral Erythropla... Erosive Lichen ...	No intervention...	45 Years -	The University of Hong Kong
Oral Cancer Screening and Education in Hong Kong	NCT04487938	Oral Cancer Oral Leukoplaki... Oral Submucous ... Proliferative V... Oral Erythropla... Erosive Lichen ...	No intervention...	45 Years -	The University of Hong Kong
Oral Epithelial Dysplasia Informational Needs Questionnaire	NCT04153266	Oral Epithelial... Precancerous Co... Precancerous Le... Oral Lichen Pla... Oral Leukoplaki... Oral Leukoplaki... Oral Leukoplaki... Oral Leukoplaki... Oral Erythropla... Chronic Hyperpl... Oral Submucous ... Oral Submucosal... Oral Disease Dental Diseases Dysplasia Information See... Patient Prefere... Information Nee... Health Behavior Quality of Life Preference, Pat... Patient Satisfa... Patient Engagem... Patient Partici...	No intervention...	18 Years -	University College, London

Spots Global Cancer Trial Database for oral submucous fibrosis