Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Same questionnaire for all three arms except validated question "Stage of decision making" followed by question about participation in screening or not when invited at age 50.

This is not an intervention but a survey study with three different versions of the questionnaire.

Same questionnaire for all three arms except text and question presenting breast cancer screening as a choice (between screening and alternative of no screening) followed by question about participation in screening or not when invited at age 50.

This is not an intervention but a survey study with three different versions of the questionnaire.

Same questionnaire for all three arms except text and question presenting breast cancer screening as an opportunity (no presentation of alternative) followed by question about participation in screening or not when invited at age 50.

This is not an intervention but a survey study with three different versions of the questionnaire.

Investigating preferences and attitudes towards breast cancer screening information, invitation, and decision making as well as barriers for breast cancer decision making. This will be done by using different framing of information (choice framing vs. opportunity framing), question about stage of decision making, and general questions about screening information and invitation.

Stage of Decision Making

Choice framing

Opportunity Framing

The aim is to investigate potential barriers to informed decision making in a breast cancer screening context. This is a necessary step prior to developing and investigating improved information or decision aids in a Danish breast cancer screening context.

In this study, preferences and attitudes towards breast cancer screening, invitation, and decision making among Danish women will be investigated. The aim is to gain knowledge about barriers for (informed) decision making in a Danish breast cancer screening context. The study will be conducted by sending out an online questionnaire to women aged 44-49 in Denmark. The questionnaire will be sent out using the official digital mail system, e-Boks, with an invitation, link, and login information to access the online questionnaire. The questionnaire will consist of background questions about the participants, questions related to the current information material and invitation to the Danish breast cancer screening program, and questions about decision making and informed choice. Women will be randomized to one of three questionnaires: 1) Questionnaire with "Stage of Decision Making" to investigate women's decision making process regarding participation in screening, 2) Questionnaire with choice framing (presentation of a choice between participation in breast cancer screening or no screening), or 3) Questionnaire with opportunity framing (only presentation of screening, no alternative) to investigate decision making process and impact of different framing. The main hypothesis for this study is that 80% of Danish women have already made their decision about screening participation when presented to the opportunity framing and 70% when presented to the choice framing.

1000 women will be invited to each group in this study and thus 3000 in total, as this is the minimum number satisfying the requirements for both the main hypothesis and secondary aims (not described in detail here). No similar studies were found, therefore, this sample size calculation is based on proportions of 50% to have enough power in our study. With a desired standard error no larger than 2.5%, 400 women are required (SE of a binomial random variable). Assuming 40% participation, a study population of 1000 women in each group is required.

Next, questionnaire data will be linked to register data on sociodemographic factors from Statistics Denmark.

The study is registered at Aarhus University's internal records: 2016-051-000001, 2563.

Investigating Barriers for Decision Making in a Danish Breast Cancer Screening Context

The main hypothesis for this study is that 80% of Danish women have already made their decision about screening participation when presented to the opportunity framing and 70% when presented to the choice framing. Further, a question about being more or less willing to participate after reading screening information will also provide information for this hypothesis.

This will be investigated by comparing the choice vs. opportunity framing, with questions about reading health information in general and about having read the information about breast cancer screening in this questionnaire. In addition, this will be investigated with questions about being more or less positive/negative about screening and more or less willing to participate after reading the screening information.

This will be investigated using two statements about seeing the participation as an individual choice or as a recommendation from health authorities to comply with.

This will be investigated with different statements about preferences regarding who should make the screening decision (the individual women or health authorities).

University of Aarhus

Symptoms and General Pathology

Mouth and Tooth 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, 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
Investigating Barriers for Decision Making in a Danish Breast Cancer Screening Context	NCT05444725	Breast Cancer F... Mammography Scr... Decision Making Information See...	Stage of Decisi... Choice framing Opportunity Fra...	44 Years - 49 Years	University of Aarhus
Investigating Barriers for Decision Making in a Danish Breast Cancer Screening Context	NCT05444725	Breast Cancer F... Mammography Scr... Decision Making Information See...	Stage of Decisi... Choice framing Opportunity Fra...	44 Years - 49 Years	University of Aarhus
Investigating Barriers for Decision Making in a Danish Breast Cancer Screening Context	NCT05444725	Breast Cancer F... Mammography Scr... Decision Making Information See...	Stage of Decisi... Choice framing Opportunity Fra...	44 Years - 49 Years	University of Aarhus
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 information seeking behavior