Oral Epithelial Dysplasia Informational Needs Questionnaire

NCT04153266 | Completed DMC

• 1 other identifier: 18/0203
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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

Oral Epithelial Dysplasia; Precancerous Conditions; Precancerous Lesions; Oral Lichen Planus; Oral Leukoplakia; Oral Leukoplakia of Tongue; Oral Leukoplakia of Lips; Oral Leukoplakia of Gingiva; Oral Erythroplakia; Chronic Hyperplastic Candidosis; Oral Submucous Fibrosis; Oral Submucosal Fibrosis, Including of Tongue; Oral Disease; Dental Diseases; Dysplasia; Information Seeking Behavior; Patient Preference; Information Needs; Health Behavior; Quality of Life; Preference, Patient; Patient Satisfaction; Patient Engagement; Patient Participation

Keywords

oral epithelial dysplasia; Precancerous Conditions; Precancerous Lesions; Information Seeking Behavior; Patient Preference; Oral Disease; Dental Diseases; Dysplasia; Quality of Life; Patient Satisfaction; Patient Participation; information needs; patient education; patient information leaflet

Outcome Measures

Primary Outcomes (1)

• ODIN-Q validation

  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).

  14 months

Secondary Outcomes (2)

• Correlations between information needs and other variables measured in the study

  14 months

• Develop a patient information leaflet about oral epithelial dysplasia

  14 months

Study Arms (1)

Patients with oral epithelial dysplasia

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.

Other: No intervention is planned for this study

Interventions

No intervention is planned for this study OTHER

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

Patients with oral epithelial dysplasia

Eligibility Criteria

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

Study Population

Participants will be patients diagnosed with OED as per current standard diagnostic criteria.

You may qualify if:

• 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.

You may not qualify if:

• Individuals under 18 years old.
• Unable to speak and read English.
• Concurrent malignancy in the head and neck or elsewhere.

Sponsors & Collaborators

• University College, London: lead
• University College London Hospitals: collaborator

Study Sites (1)

University college london hospitals

London, Wc1x 8ld, United Kingdom

Location

Related Publications (1)

• Alsoghier 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 BACKGROUND

Related Links

• Preparatory work to inform the current study

MeSH Terms

Conditions

Precancerous Conditions; Lichen Planus, Oral; Leukoplakia, Oral; Oral Submucous Fibrosis; Mouth Diseases; Stomatognathic Diseases; Information Seeking Behavior; Patient Preference; Health Behavior; Patient Satisfaction; Patient Participation

Condition Hierarchy (Ancestors)

Neoplasms; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Leukoplakia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Communication; Behavior; Treatment Adherence and Compliance; Patient Acceptance of Health Care

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 6, 2019
• Study Start: October 31, 2018
• Primary Completion: December 21, 2019
• Study Completion: December 21, 2019
• Last Updated: April 2, 2020

Record last verified: 2020-03

Locations

GB (1)