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Oral Epithelial Dysplasia Informational Needs Questionnaire (ODIN-Q)

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ClinicalTrials.gov Identifier: NCT04153266
Recruitment Status : Completed
First Posted : November 6, 2019
Last Update Posted : April 2, 2020
Sponsor:
Collaborator:
University College London Hospitals
Information provided by (Responsible Party):
University College, London

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.


Condition or disease Intervention/treatment
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 Other: No intervention is planned for this study

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.

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Study Type : Observational
Actual Enrollment : 128 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of an Oral Epithelial Dysplasia Informational Needs Questionnaire
Actual Study Start Date : October 31, 2018
Actual Primary Completion Date : December 21, 2019
Actual Study Completion Date : December 21, 2019


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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Correlations between information needs and other variables measured in the study [ Time Frame: 14 months ]
    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).

  2. Develop a patient information leaflet about oral epithelial dysplasia [ Time Frame: 14 months ]
    To develop and assess the satisfaction with a patient information leaflet [PIL] about OED (phase 2).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be patients diagnosed with OED as per current standard diagnostic criteria.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04153266


Locations
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United Kingdom
University college london hospitals
London, United Kingdom, Wc1x 8ld
Sponsors and Collaborators
University College, London
University College London Hospitals
Additional Information:
Publications:
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT04153266    
Other Study ID Numbers: 18/0203
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College, London:
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
Additional relevant MeSH terms:
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Precancerous Conditions
Leukoplakia
Leukoplakia, Oral
Carcinoma in Situ
Lichen Planus, Oral
Mouth Diseases
Stomatognathic Diseases
Oral Submucous Fibrosis
Lichen Planus
Fibrosis
Hyperplasia
Pathologic Processes
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Neoplasms
Pathological Conditions, Anatomical
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type