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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date March 2020
Source University College, London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms

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

Intervention

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

Locations

Country Name City State
United Kingdom University college london hospitals London

Sponsors (2)

Lead Sponsor Collaborator
University College, London University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

Outcome

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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