Testing Accountability in Patient Adherence
9 de setembro de 2019 atualizado por: M.D. Anderson Cancer Center
The goal of this research study is to look for factors that influence whether or not head and neck cancer patients follow the swallowing exercises that they are asked to perform while receiving radiation treatment.
Visão geral do estudo
Status
Desconhecido
Condições
Intervenção / Tratamento
Descrição detalhada
Head and neck cancer patients who receive radiation are at risk for permanent swallowing disorders. Because of these potential problems, swallowing exercises are an important part of recovery. Researchers want to learn what factors affect how well patients follow the swallowing schedule they are given, and what can be done to make it consistent.
If you agree to take part in this study, you will have the following procedures performed.
Videotaped Swallowing Exercise:
Researchers will ask you to perform 3 swallowing exercises while being recorded by a video camera. The length of the taping session will be 3 minutes. Afterward, you will fill out 3 questionnaires. The questionnaires will take about 10 minutes to complete.
Length of Study:
You will be asked to come in 1 time for this study.
For the next 2 years, information may be collected from your medical record. This information will include the cancer stage, if the disease has gotten worse, any treatment you receive, and any side effects you experience. This information will help researchers learn how certain treatments affect patients and their risk for future disease.
This is an investigational study.
Up to 225 patient will take part in this study. All will be enrolled at MD Anderson.
Tipo de estudo
Observacional
Inscrição (Antecipado)
225
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Texas
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Houston, Texas, Estados Unidos, 77030
- University of Texas MD Anderson Cancer Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Head and neck cancer patients receiving radiation therapy at MDACC clinics.
Descrição
Inclusion Criteria:
- Are dispositioned to receive radiation with curative intent for nasopharyngeal, oropharyngeal, hypopharyngeal, laryngeal, or an unknown primary cancer with cervical metastases.
- Are stage II-IVB for oropharyngeal and laryngeal
- Are stage I-IVB for hypopharyngeal and nasopharyngeal
- At least 18 years of age
- Speak and read English
- Oriented to time, person, and place
- Have a Zubrod performance status of 0 to 2
Exclusion Criteria:
- Have other cancer diagnoses, except non-melanoma skin cancer
- Had treatment for previous H & N cancer or radiation to the head and neck
- Have a history of previous head and neck surgery (excluding biopsy and/or tonsillectomy and/or tracheotomy)
- Have a current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g., dysphagia due to underlying neurogenic disorder)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Group 1(High Accountability-Human Monitoring)
Participants randomly assigned to receive one of three sets of instructions before starting.
Instructions for three swallowing exercises as well as an introductory script explaining the purpose of the exercises will be videotaped and shown to participants.
Participants perform 3 swallowing exercises while researcher leaves the room.
At the end of the testing period, researcher will come back into the room and record the number on participant's tracking device.
Participant to tell whether they did as many repetitions as possible and if not, why they were not able to do as many as possible.
This portion of the experiment will be videotaped.
Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before procedure as well as a brief 3-page post-session questionnaire.
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Participants perform 3 swallowing exercises.
Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before swallowing exercise procedure.
Participants fill out 3 questionnaires after swallowing exercises.
The questionnaires will take about 10 minutes to complete.
Outros nomes:
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Group 2(Low Accountability-Human Monitoring)
Participants randomly assigned to receive one of three sets of instructions before starting.
Instructions for three swallowing exercises as well as an introductory script explaining the purpose of the exercises will be videotaped and shown to participants.
Participants perform 3 swallowing exercises while researcher leaves the room.
At the end of the testing period, researcher will come back into the room and record the number on participant's tracking device.
Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before procedure as well as a brief 3-page post-session questionnaire.
|
Participants perform 3 swallowing exercises.
Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before swallowing exercise procedure.
Participants fill out 3 questionnaires after swallowing exercises.
The questionnaires will take about 10 minutes to complete.
Outros nomes:
|
|
Group 3(Low Accountability-Technological Monitoring)
Participants randomly assigned to receive one of three sets of instructions before starting.
Instructions for three swallowing exercises as well as an introductory script explaining the purpose of the exercises will be videotaped and shown to participants.
Participants perform 3 swallowing exercises while researcher leaves the room.
At the end of the testing period, researcher will come back into the room and record the number on participant's tracking device.
The videocamera will tape participant's session so evaluation can be made as to exercise accuracy.
Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before procedure as well as a brief 3-page post-session questionnaire.
|
Participants perform 3 swallowing exercises.
Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before swallowing exercise procedure.
Participants fill out 3 questionnaires after swallowing exercises.
The questionnaires will take about 10 minutes to complete.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Adherence to Swallowing Exercises
Prazo: 1 day
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Purpose of experiment is to determine whether an accountability manipulation and whether human vs technological monitoring result in higher patient adherence.
Main outcome measure is perseverance of effort which will be number of repetitions within one minute interval for each exercise.
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1 day
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Eileen H. Shinn, PHD, MS, BA, M.D. Anderson Cancer Center
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de maio de 2013
Conclusão Primária (Antecipado)
1 de dezembro de 2020
Conclusão do estudo (Antecipado)
1 de dezembro de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
29 de abril de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de abril de 2013
Primeira postagem (Estimativa)
1 de maio de 2013
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de setembro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de setembro de 2019
Última verificação
1 de setembro de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2013-0195
- 5R01DE019141-03 (Concessão/Contrato do NIH dos EUA)
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