Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

People diagnosed with advanced lung cancer and scheduled to receive palliative RT will be invited to participate between 1st July 2019 and 31st January 2020.

Patients' family caregivers will also be invited to participate

Two questionnaires in patients and another two questionnaires in carer.

questionnaires

Saengrawee Thanthong

the purpose of this study is to investigate over time patients' symptom burden, caregiving burden, and patients and caregivers' need for information on patient symptom self-management at home during palliative radiotherapy(RT) for lung cancer. Repeatedly assessing burden and information needs on symptom self-management at home can help healthcare professionals to design a bespoke service and plan of care for both patients and family caregivers. In addition, I will explore psycho-social and clinical predictors of burden and information needs in patients and caregivers. These predictors can help health professionals to identify patients and caregivers at risk for distress during palliative radiotherapy for lung cancer.

Eligible patients will be invited to take part in the study via a patient information sheet. They will also be asked to nominate their primary caregiver, who will also be invited to take part in the study. We will give patients and caregivers 24 hours to decide whether they want to take part or not. If they do decide to take part, all research participants will be involved in the study on four consecutive occasions before, during and after their treatment. These four time points will be the following:

* before first fraction of RT
* 1st week of RT (1st-5th faction)
* 2nd week of RT (6th-10th fraction)
* 1 month after the last fraction of RT The principal researcher, i.e. Saengrawee Thanthong, will endeavour to collect questionnaires in the hospital. If participants cannot come to the hospital to receive radiotherapy or for their follow up appointment and complete the questionnaire, then the principal researcher will call them and offer to complete the questionnaires over the phone so as to minimise missing data due to attrition.

Descriptors and Predictors of Burden and Information Needs

Descriptors and Predictors of Burden and Information Needs on Symptom Self-management in Thai Patients With Lung Cancer and Their Family Caregivers During Palliative Radiotherapy

Measure by the Thai version of modified version of the Memorial Symptom Assessment Scale (MSAS)

information need on symptom self-management at home measure by The Supportive Care Needs Survey - Patient version (SCNS) (Bonevski et al., 2000\& McElduf et al., 2004) and Partners and Caregivers version (SCNS-P\&C) - Information needs subscale.

University of Glasgow

Chulabhorn Cancer Center

Principal Investigator

Symptoms and General Pathology

Mouth and Tooth Diseases

Skin and Connective Tissue Diseases

Infections

Behaviors and Mental Disorders

Rare Diseases

Fibrosis

Lichen Planus, Oral

Lichen Planus

Hyperplasia

Candidiasis

Mouth Diseases

Precancerous Conditions

Oral Submucous Fibrosis

Leukoplakia

Leukoplakia, Oral

Erythroplasia

Carcinoma

Carcinoma in Situ

Stomatognathic Diseases

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	Link
Descriptors and Predictors of Burden and Information Needs	NCT04069494	Advanced Lung C... Symptoms	questionnaires	18 Years -	Chulabhorn Cancer Center
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

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