Oral Epithelial DysplasiaODIN-QNCT04153266
Oral Epithelial Dysplasia Informational Needs Questionnaire
An observational study of Oral Epithelial Dysplasia and Precancerous Conditions, run by University College, London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Epithelial Dysplasia, Precancerous Conditions, Precancerous Lesions
- How many people
- 128 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Oct 2018to 21 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be patients diagnosed with OED as per current standard diagnostic criteria.
Who may be able to join
- 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.
Who cannot join
- Individuals under 18 years old.
- Unable to speak and read English.
- Concurrent malignancy in the head and neck or elsewhere.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University college london hospitals
London, Wc1x 8ld
About this study
Official title: Development of an Oral Epithelial Dysplasia Informational Needs Questionnaire
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Oral Epithelial Dysplasia, Precancerous Conditions, Precancerous Lesions, Oral Lichen Planus, Oral Leukoplakia, Oral Leukoplakia of Tongue
- Being tested
- No intervention is planned for this study
- 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
- Medical subject headings
- Precancerous Conditions, Lichen Planus, Oral, Leukoplakia, Oral, Oral Submucous Fibrosis, Mouth Diseases, Stomatognathic Diseases, Information Seeking Behavior, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention is planned for this studyOther
No intervention was/is planned for this study. The study is questionnaire-based (observational).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention is planned for this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 14 months
Secondary outcomes (2)
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).
Measured: 14 months
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).
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start31 Oct 2018
- Primary completion21 Dec 2019
- Study completion21 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Epithelial DysplasiaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153266
- Sponsor's protocol ID
- 18/0203
- Acronym
- ODIN-Q
- Status last verified
- Mar 2020
- First submitted
- 4 Nov 2019
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29909904
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Oral Epithelial Dysplasia Informational Needs Questionnaire
- ClinicalTrials.gov ID
- NCT04153266
- Acronym / sponsor ID
- ODIN-Q / 18/0203
- Conditions
- Oral Epithelial Dysplasia, Precancerous Conditions, Precancerous Lesions, Oral Lichen Planus, Oral Leukoplakia, Oral Leukoplakia of Tongue
- Keywords
- oral epithelial dysplasia, Precancerous Conditions, Precancerous Lesions, Information Seeking Behavior, Patient Preference, Oral Disease, Dental Diseases, Dysplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University College London Hospitals
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 21 Dec 2019 (actual)
- Study completion
- 21 Dec 2019 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with oral epithelial dysplasia | – | Other: No intervention is planned for this studyINCLUSION 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be patients diagnosed with OED as per current standard diagnostic criteria.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Individuals under 18 years old.
- Unable to speak and read English.
- Concurrent malignancy in the head and neck or elsewhere.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention is planned for this studyNo intervention was/is planned for this study. The study is questionnaire-based (observational). | Other | Patients with oral epithelial dysplasia |
Primary outcome
ODIN-Q validation
Time frame: 14 months
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).
2 secondary outcomes
Correlations between information needs and other variables measured in the study
Time frame: 14 months
Develop a patient information leaflet about oral epithelial dysplasia
Time frame: 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Background: PubMed 29909904Alsoghier 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.
- Preparatory work to inform the current studyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Epithelial Dysplasia and Precancerous Conditions, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ODIN-Q validation (time frame: 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04153266, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.