Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Mouth and Tooth Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Breast Neoplasms

Sarcoma

Cleft Lip

Mouth Diseases

Stomatognathic Diseases

Congenital Abnormalities

Mouth Abnormalities

Stomatognathic System Abnormalities

Soft Tissue Sarcoma

Patient Leaflet with Augmented reality component

Traditional leaflet without Augmented Reality component

The patient leaflet has an Augmented Reality model that appears out of the leaflet when viewed with a smartphone

Augmented Reality

Traditional leaflet with no Augmented Reality capability

Traditional leaflet

Steven Lo, FRCS Plast

David McGill, FRCS Plast

Steven Lo

This project aims to assess a new type of Augmented Reality Patient Information leaflet, in order to demonstrate that it is a beneficial information resource to patients when facing the diagnosis of sarcoma, breast cancer or to explain difficult concepts such as cleft lip repair. There are no published studies on the use of AR in patient leaflets.

At present, the traditional approach to patient education regarding diseases such as a new cancer diagnosis, is the patient information leaflet. Patient information leaflets often fail to convey the required medical information due to poor levels of literacy in the population, with 20% patients in the UK having the lowest level of adult literacy (equivalent to an individual who is unable to determine how much medicine to give a child from information printed on the package). "Health literacy" - the ability to obtain, understand, act on and communicate health information - is even lower, with estimates that 40% of patients have inadequate levels of health literacy. Additionally, there is a large knowledge gap between what doctors perceive patients understand about an illness, medication, or operation, and what patients actually comprehend and retain during consultation.

The plethora of problems of inadequate information, poor health literacy and patient-doctor knowledge disconnect, may be addressed with an approach to patient information leaflets using a platform that is entirely simulative and visual, thereby overcoming the problem of health literacy. The study builds upon pilot work by this research team on patient leaflets using AR to aid in patient education, visualisation and retention of information (Lo et al 2019).

It is not possible to blind participants to visual information in the patient leaflet (augmented reality versus traditional). The data collected will be fully anonymised before statistical assessment by an independent statistical service

Augmented Reality (AR): The Future of "Patient Information Leaflets

Available on reasonable written request following publication.

Patients will be interviewed regarding opinions of the two types of patient leaflet.

Validated scale for cognitive load/ ease of understanding leaflet. Single item scale with rating 1 = very, very low mental effort to 9 = very, very high mental effort. Lower score is better

Visual analogue scale, overall satisfaction with patient leaflet. Visual analogue scale will be converted to numerical scale 0-100, with higher being better or more satisfied

Assessment of patient learning motivation after reading leaflet. 36 items, each item rated by Likert scale 1-5. Higher score is better.

9 item scale with Likert rating 0-10 for each item. Total score out of 90, with 3 sub scales measuring cognitive, emotional and behavioural dimensions. Higher score is better.

The Glasgow School of Art

NHS Greater Glasgow and Clyde

patient information leaflet

Susan J Palmer

The purpose of this study is to investigate the feasibility of carrying out a full scale randomised controlled trial to compare the effects of giving additional information versus no additional information to patients prior to their first oncology appointment.

Hypothesis: Patients with some awareness of research provided prior to clinic appointment in oncology and aware of the possibility of being invited to take part in a clinical trial are more likely to agree to participate.

The recruitment of cancer patients into clinical trials may be hindered by several factors such as limited understanding of medical research, a lack of information about the type of research on offer for patients, over load of information when given a new and life limiting diagnosis. Nor does the Churchill Hospital inform patients that research is an integral part of the every day life and business of the hospital.

Does increasing research awareness impact on accrual?

This initial study aims to establish the feasibility of a larger study to gather the evidence required to investigate whether patients need some information indicating that a hospital participates in research, and what it may mean to the individuals to participate, including new terminology; thus reducing fear and anxiety and ultimately increasing the accrual of cancer patients into cancer clinical trials. Prior knowledge of patients' attitudes to involvement in clinical trials might assist communication about trials and encourage more doctors to approach eligible patients. In the NHS there is always a fear of cost implications, however a study comparing two New Patient Information Packs (NPIPs) showed no differences were detected between a full pack and a mini pack and given the cost, the mini-New Patient Information Pack (mini-NPIP) was the preferred approach. This has influenced the decision to provide only a brief leaflet of information to patients prior to their first appointment.

The National Cancer Research Network (NCRN) was formed three years ago with the aim to provide the NHS infrastructure to support and improve patient care by speeding up access to the best treatment and care, provide information and support to our patients and improve the speed of research by increasing the number of patients into clinical trials. In the Thames Valley Cancer Research Network (TVCRN) accrual has increased from 2.7% in 2001-2 to 8.3% in 2003-4. The infrastructure to support research is in place, clinicians are informed and have relevant nursing and administrative support to offer trials to patients and cope with the increased numbers of patients taking part. There appears to be a deficit in the research knowledge and understanding of the general public. It is easier and less stressful to 'opt out' when faced with a new diagnosis and complicated treatment options than to consider, in addition, a clinical trial. By measuring accrual and evaluating the patients' response to information about research I intend to investigate the feasibility of a larger study to provide the evidence to investigate the need for pre-first-visit research information. Thus investigating the requirement, importance and need for information for the patients before their first oncology appointment and the general public.

Ellis, Buttow and Tattersall have published two studies conducted with breast cancer patients: the first in 2001 found that that women who have a better knowledge of clinical trials are more willing to consider participating in a clinical trial, however in 2002 patients who had received a booklet of information about research for patients were significantly less likely to consider participating in a randomised clinical trial (RCT). Using a very large sample (n=2331) Jenkins, Fallowfield and Saul showed that the vast majority of cancer patients questioned wanted a great deal of specific information concerning their illness and treatment.

RAW Study Version 3.4

Does Increasing Research Awareness Impact on Accrual? A Feasibility Study. Protocol Version 3.4 Dated April 2005.

Liverpool John Moores University

National Cancer Research Network

Oxford University Hospitals NHS Trust

Symptoms and General Pathology

Infections

Behaviors and Mental Disorders

Fibrosis

Lichen Planus, Oral

Lichen Planus

Hyperplasia

Candidiasis

Precancerous Conditions

Oral Submucous Fibrosis

Leukoplakia

Leukoplakia, Oral

Erythroplasia

Carcinoma

Carcinoma in Situ

Lichenoid Eruptions

Exanthema

Skin Diseases

Skin Diseases, Papulosquamous

Pathological Conditions, Anatomical

Mouth Neoplasms

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Quality of Life

Chronic Graft Versus Host Disease

Erythroplakia

Oral Leukoplakia

Oral Cancer

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.

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

No intervention is planned for this study

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.

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.

Oral Epithelial Dysplasia Informational Needs Questionnaire

Development of an Oral Epithelial Dysplasia Informational Needs Questionnaire

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).

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).

To develop and assess the satisfaction with a patient information leaflet \[PIL\] about OED (phase 2).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Augmented Reality (AR): The Future of "Patient Information Leaflets	NCT04619030	Sarcoma Breast Cancer Cleft Lip and P... Surgical Flap	Augmented Reali... Traditional lea...	16 Years - 90 Years	NHS Greater Glasgow and Clyde
RAW Study Version 3.4	NCT00280722	Cancer	patient informa...	18 Years -	Oxford University Hospitals NHS Trust
RAW Study Version 3.4	NCT00280722	Cancer	patient informa...	18 Years -	Oxford University Hospitals NHS Trust
Augmented Reality (AR): The Future of "Patient Information Leaflets	NCT04619030	Sarcoma Breast Cancer Cleft Lip and P... Surgical Flap	Augmented Reali... Traditional lea...	16 Years - 90 Years	NHS Greater Glasgow and Clyde
RAW Study Version 3.4	NCT00280722	Cancer	patient informa...	18 Years -	Oxford University Hospitals NHS Trust
Oral Epithelial Dysplasia Informational Needs Questionnaire	NCT04153266	Oral Epithelial... Precancerous Co... Precancerous Le... Oral Lichen Pla... Oral Leukoplaki... Oral Leukoplaki... Oral Leukoplaki... Oral Leukoplaki... Oral Erythropla... Chronic Hyperpl... Oral Submucous ... Oral Submucosal... Oral Disease Dental Diseases Dysplasia Information See... Patient Prefere... Information Nee... Health Behavior Quality of Life Preference, Pat... Patient Satisfa... Patient Engagem... Patient Partici...	No intervention...	18 Years -	University College, London

Spots Global Cancer Trial Database for patient information leaflet