Clinical trial · Observational
Oral Epithelial Dysplasia Informational Needs Questionnaire
Development of an Oral Epithelial Dysplasia Informational Needs Questionnaire
- 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)
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.
Conditions
Conditions (24)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Hyperplastic Candidosis | — | UNRESOLVED | — |
| Dental Diseases | — | UNRESOLVED | — |
| Dysplasia | — | UNRESOLVED | — |
| Health Behavior | — | UNRESOLVED | — |
| Information Needs | — | UNRESOLVED | — |
| Information Seeking Behavior | — | UNRESOLVED | — |
| Oral Disease | — | UNRESOLVED | — |
| Oral Epithelial Dysplasia | — | UNRESOLVED | — |
| Oral Erythroplakia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention is planned for this study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with oral epithelial dysplasia
- description
- 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.
- interventionNames
- Other: No intervention is planned for this study
Primary outcomes (1)
- measure
- ODIN-Q validation
- timeFrame
- 14 months
- description
- 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).
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults aged 18 or above at the time of the screening visit. * Good command of English language both written and spoken. * Being able to consent. * Diagnosed with OED by histopathological examination as per the 2017 classification of head and neck tumours by the World Health Organization. * No concurrent malignancy in the head and neck or elsewhere. Exclusion Criteria: * Individuals under 18 years old. * Unable to speak and read English. * Concurrent malignancy in the head and neck or elsewhere.
References
Publications (1)
- BACKGROUNDAlsoghier A, Ni Riordain R, Fedele S, Porter S. Web-based information on oral dysplasia and precancer of the mouth - Quality and readability. Oral Oncol. 2018 Jul;82:69-74. doi: 10.1016/j.oraloncology.2018.05.003. Epub 2018 May 17. PMID 29909904