- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07328347
Melhorar os Cuidados Dentários para Pacientes com Tumores da Cabeça e Pescoço (OncoDent)
Um Experimento de Simulação para Melhorar os Cuidados Dentários em Pacientes com Tumores da Cabeça e Pescoço
This prospective survey study investigates knowledge, attitudes, experiences, and practices related to dental care in patients with head and neck cancer among affected patients and dentists. Participants complete an anonymous online questionnaire before and after receiving written, guideline-based information. The study aims to evaluate whether targeted educational materials improve knowledge and perceptions regarding dental care in the context of head and neck cancer treatment.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This study is a prospective survey-based study using a pre-post design. Patients with head and neck cancer and practicing dentists are invited to participate. Patient recruitment is carried out through existing self-help networks and direct personal contact. National and regional self-help groups for head and neck cancer patients are contacted and asked to disseminate information about the study, including a study information sheet and a QR code linking to the online questionnaire, via their communication channels. Dentists receive an invitation letter containing the QR code to the online questionnaire by postal mail.
Participation in the study is voluntary and anonymous. By completing the online questionnaire, participants provide informed consent to participate. Due to the anonymous nature of data collection, withdrawal from the study is no longer possible after submission of the questionnaire. The survey is conducted in accordance with the data protection requirements of the Data Protection Officer of University Medical Center Göttingen, and participants are informed accordingly.
All participants initially complete a baseline questionnaire (pre-assessment) collecting demographic data as well as information on knowledge, behavior, attitudes, and experiences related to dental care for patients with head and neck cancer. Subsequently, a written educational intervention is provided. For patients, this consists of concise summaries of patient guidelines on oral cavity cancer, pharyngeal cancer, and supportive care. For dentists, the intervention includes concise summaries of relevant S3 clinical practice guidelines covering diagnosis, treatment, prevention, and follow-up of laryngeal cancer, oro- and hypopharyngeal cancer, oral cavity cancer, implant-based oral rehabilitation after head and neck radiotherapy, and supportive care in oncology.
The survey for each participant group (patients and dentists) is conducted as a single, continuous, and structured session. After accessing the educational intervention, participants are no longer able to modify their responses to the pre-assessment questionnaire. A second questionnaire with identical content is then completed (post-assessment). The effect of the educational intervention is evaluated by calculating the change (Δ) between pre- and post-assessment values.
The development of the educational interventions was informed by findings from a preceding qualitative interview study involving dentists, otolaryngologists, radiation oncologists, and patients with head and neck cancer.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Göttingen, Alemanha, 37075
- University Medical Center Göttingen
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Patients aged 18 years or older with head and neck cancer whose health status allows completion of a questionnaire
- Practicing dentists in Germany registered in the OAK-Verlag address database
Exclusion Criteria:
- Lack of consent to participate
- Insufficient German language skills that prevent completion of the questionnaire
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: Patients With Head and Neck Cancer/Dentists - Educational Information Intervention
Patients with head and neck cancer and practicing dentists in Germany participate in an anonymous, prospective pre-post survey study. |
Patients with head and neck cancer and practicing dentists in Germany participate in an anonymous, prospective pre-post survey study. Both groups complete a baseline questionnaire assessing demographic characteristics as well as knowledge, attitudes, experiences, and decision-making related to dental care in the context of head and neck cancer treatment. Following the baseline assessment, participants receive group-specific, guideline-based written educational information. After reviewing the educational material, participants complete a post-intervention questionnaire with identical content. The effect of the educational intervention is evaluated by comparing pre- and post-assessment responses within each group. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change From Baseline in Knowledge and Decision-Making Regarding Dental Care, Assessed by a Self-Administered Questionnaire (Percentage of Correct Responses)
Prazo: Immediately after completion of the educational intervention (single study visit)
|
Study outcomes are defined as the effects of the interventions measured using a self-administered questionnaire. Questionnaire responses are summarized as a percentage score ranging from 0% to 100%, with 100% indicating all responses answered correctly. For each research question, outcomes are calculated as the change (Δ) in percentage scores between pre-intervention (baseline) and post-intervention assessments. |
Immediately after completion of the educational intervention (single study visit)
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 15/11/25
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .