EDUCAT-ED (V1.0)

• Research type

  Research Study

• Full title

  Patient Education in Oral Epithelial Dysplasia

• IRAS ID

  318039

• Contact name

  Stephen Porter

• Contact email

  s.porter@ucl.ac.uk

• Sponsor organisation

  University College London

• Clinicaltrials.gov Identifier

  Z6364106/2022/11/27, UCL Data Protection Number

• Duration of Study in the UK

  1 years, 5 months, 1 days

• Research summary

  Background: Oral Epithelial Dysplasia (OED) is a condition that may proceed the development of oral malignancy. Following a diagnosis of dysplasia, poor provision of health information and inadequate doctor-patient communication can lead to the development of anxiety and depression. The provision of appropriate and timely information, when tailored to the medical condition and patients’ needs and preferences, increases patients ability to cope with their disease, supports participation in decision-making, reduces anxiety and distress, and improves adherence to therapy. Assessment of information needs of patients with OED can be established using the Oral Epithelial Dysplasia Informational Needs Questionnaire (ODIN-Q). Once patient information needs have been established it is then necessary to deliver timely, comprehensive, and easily understandable patient education for patients with OED. The development and delivery of universally accessible educational material for patients has been recommended.

  Project aims: The primary objectives of this study is to (1) to determine the structural validity of ODIN-Q in patients with OED (phase 1); (2) to develop patient information educational materials (written and audiovisual) for OED (phase 1), to be used in a clinical setting (phase 2); (3) to determine the responsiveness of ODIN-Q, pre and post patient educational interventions (phase 2).
  The secondary objective is to determine which type of patient information (audio/visual, digital, paper format) should be used in patients with OED (phase 2).

  Timescale: 18 months

  Clinical significance: Further evaluation of ODIN-Q psychometric properties, including structural validity and responsiveness and the development of educational tools could be critical, providing patients with accurate disease information in order to make informed decisions about their treatment plans and to decrease uncertainty.

  Lay summary of study results: This research explored how people with a mouth condition called oral epithelial dysplasia (OED)—a change in the lining of the mouth that can sometimes develop into oral cancer—find and understand health information, and how healthcare professionals can better support their needs.

  Online information
  The study found that while some videos about OED on websites like YouTube were made by professionals and contained useful information, many others were incomplete or of poor quality. Because so many people now rely on social media for health information, it is important for professionals to be more active online and to create clear, trustworthy, and easy-to-understand educational materials.

  Patient experiences
  Interviews with patients showed that many faced delays in getting a diagnosis and often lacked clear information about their condition. This caused worry and uncertainty. Patients said they valued honest, simple explanations and clear communication from their clinicians. These findings highlight how important it is to give patients the right information at the right time to reduce anxiety and improve their overall experience.

  Information needs
  A survey study was carried out to understand what people with OED know about their condition and what further information they need. The results showed that while some patients had a good understanding, many wanted more information about risk factors (like tobacco or alcohol use), emotional impacts, and where to find support. Most patients said that talking directly with healthcare professionals was their preferred and most trusted way to learn about their condition.

  Developing and testing a new questionnaire
  Finally, a recently developed questionnaire called the Oral Epithelial Dysplasia Informational Needs Questionnaire (ODIN-Q) was tested. This tool helps measure what information patients need and whether educational materials improve their understanding. The results showed that the ODIN-Q works well in identifying patient needs and can detect improvements after patients are given new information. It can therefore be used by doctors and dentists to ensure that patient education is tailored, effective, and patient-centred.
  Has the registry been updated to include summary results?: No
  If yes - please enter the URL to summary results:
  If no – why not?: N/A
  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
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  If pending, date when dissemination is expected:
  If no, explain why you didn't follow it:
  Have participants been informed of the results of the study?: Yes
  If yes, describe and/or provide URLs to materials shared and how they were shared: Study results will be shared with participants and the wider public through published journal articles. These will be made available upon request.

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  If pending, date when feedback is expected:
  If no, explain why they haven't:
  Have you enabled sharing of study data with others?: Yes
  If yes, describe or provide URLs to how it has been shared: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F37518951%252F%2FNBTI%2FRKvAAQ%2FAQ%2Ffe84f179-aed6-41b7-8dea-1d24f71ba488%2F1%2FOiJgxlNZe3&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C0bec2185484e4899b08a08de0a40f686%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638959471338554771%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=PHNm6P5wbAzLfBoE%2B8H3Exi8tQHaxgt6A6ZLZ72vb%2BM%3D&reserved=0 https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F39962928%252F%2FNBTI%2FRKvAAQ%2FAQ%2Ffe84f179-aed6-41b7-8dea-1d24f71ba488%2F2%2FMW2OpfIRRT&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C0bec2185484e4899b08a08de0a40f686%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638959471338577186%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1q631Neoy3Zmk2iLvdXJSlc%2FKzTF2WY4csQgQW62CmI%3D&reserved=0 https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F40360396%252F%2FNBTI%2FRKvAAQ%2FAQ%2Ffe84f179-aed6-41b7-8dea-1d24f71ba488%2F3%2FL_kZYKSKX6&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C0bec2185484e4899b08a08de0a40f686%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638959471338597233%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=K2BJ3KZu9ORHTSPH9TdSsi37rqKGtzrDCRqH2x4g6GA%3D&reserved=0 https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F40341744%252F%2FNBTI%2FRKvAAQ%2FAQ%2Ffe84f179-aed6-41b7-8dea-1d24f71ba488%2F4%2FskoGY5DNJ_&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C0bec2185484e4899b08a08de0a40f686%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638959471338615098%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=lEG6pWLosENabG2shwLAlSgfdypfzXEGBRBjKeuAEEA%3D&reserved=0
  If no, explain why sharing hasn't been enabled:
  Have you enabled sharing of tissue samples and associated data with others?: No
  If yes, describe or provide a URL:
  If no, explain why: N/A
  Captcha: 0cAFcWeA6XKN_cmzR-fwRj1rJjDyRre_PA5UW-V1ZX1eOdD3jY67fjoFAooEyC1LirI7fCbqJNdBQNFtriFAYyKPO76My6-ywVTjzItcb0hHwRKfXXVTF_w5to2-sO0_twX8KH_wpvZbNy4KARLnlmb5OttWNIbhBF4VX8QKP70Ug4HP9q9brpHvdfhJY3G0ZLWHJw62kdrsRLLVNQVefi641YTiw52oVXTOsPMOMsbSn0eefad8oMLAbran8oET2yUaZHMirqYCq0IyGNvAC2k8vZgPJZmYp7l9CAsfkSEfuPRJINOdmfWsoPxtTz7zwN3JUrmh4qdVqGIOaooi5DvD3tRA9ngCTuQv_4Vn_1Un4cCPFJe9XMFGo7tr_YwMP1ePQhRrrbUscdXL1exa53BhbqGo7eP1na3sZSaP5ZZ_rncmJxOuAge2AWKvfmzvEGvLPMCiF8cMrLeDlljj58G2kvlUZ5dvCwWs6X4o3qD44gMT63nn_28nTKRP4WoQcaw4kJWIaSrmT0dfc1BMSb5RS3sxL-Vy07pEnqgbg_N-Zuj0-VIrLUD7G1tP6TalCY58YJqdBR7yRL82BM3n-qBpSl8mi6x-omeRBRUgcnxDuCTdo4uepE1ZnzZhEOY2VvKs3Zs_uWHXacL2HHYmal6hexi_ZweCRZw5KSRPpAvnubyy24RgLnwj8Dbk0bSwPQGgXxgw7hObtAbVXWckqsrsA0rHJZPk2240sRAecSFkx-3jOREfhtJpeO6AK4DQp7sAohC3uHXqWv-aBiiBeC6VDijpLOMleEaz4Cs_qV4QM99_fdgM5aIzA2pgCqFDOBpAnHAUMCt0_g
  

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  22/PR/1743

• Date of REC Opinion

  16 Jan 2023

• REC opinion

  Favourable Opinion