Quality of Life Clinical Trial
— ODIN-QOfficial title:
Development of an Oral Epithelial Dysplasia Informational Needs Questionnaire
NCT number | NCT04153266 |
Other study ID # | 18/0203 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 31, 2018 |
Est. completion date | December 21, 2019 |
Verified date | March 2020 |
Source | University College, London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 128 |
Est. completion date | December 21, 2019 |
Est. primary completion date | December 21, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University college london hospitals | London |
Lead Sponsor | Collaborator |
---|---|
University College, London | University College London Hospitals |
United Kingdom,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Correlations between information needs and other variables measured in the study | 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). | 14 months | |
Secondary | Develop a patient information leaflet about oral epithelial dysplasia | To develop and assess the satisfaction with a patient information leaflet [PIL] about OED (phase 2). | 14 months |
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