- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02649569
Continuous Activity Monitoring During Fractionated Radiotherapy in Patients With Head and Neck, Lung, or Gastrointestinal Cancer
Continuous Activity Monitoring During Fractionated Radiotherapy: A Pilot Study
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
PRIMARY OBJECTIVES:
I. To demonstrate the feasibility of continuous, accelerometer-based evaluation of patient activity levels before, during, and after treatment with fractionated external beam radiotherapy.
SECONDARY OBJECTIVES:
I. To demonstrate the feasibility of performing weekly quality of life assessments during fractionated external beam radiotherapy.
II. To explore how accelerometer-based metrics change throughout patients' treatment courses and if these changes are associated with quality of life assessments, treatment interruptions, hospitalizations, and clinical outcomes.
OUTLINE:
Patients wear an activity monitor throughout and up 4 weeks after completion of radiation therapy. Patients who are willing may continue to wear the monitor through routine follow up appointments. Patients also complete questionnaires at evaluations, which take place prior to radiotherapy initiation, weekly during radiotherapy, and then 2 and 4 weeks after the completion of radiotherapy.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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-
New York
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Bronx, New York, Estados Unidos, 10461
- Albert Einstein College of Medicine
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Bronx, New York, Estados Unidos, 10467-2490
- Montefiore Medical Center - Moses Campus
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Able to ambulate independently (without the assistance of a cane or walker)
- Diagnosis of invasive malignancy of the head and neck region, lung, or gastrointestinal tract
- Planned treatment with fractionated (>= 15 treatments) external beam radiotherapy with concurrent chemotherapy with curative intent
Women of childbearing potential must:
- Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy
- Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed
- Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy
- All patients must sign study specific informed consent prior to study entry
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
---|---|
Observational (continuous activity monitoring, questionnaires)
Patients wear an activity monitor throughout and up 4 weeks after completion of radiation therapy.
Patients who are willing may continue to wear the monitor through routine follow up appointments.
Patients also complete questionnaires at evaluations, which take place prior to radiotherapy initiation, weekly during radiotherapy, and then 2 and 4 weeks after the completion of radiotherapy.
|
Wear activity monitor
Outros nomes:
Complete the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Number of patients who complete most (>= 80%) of the protocol-specified assessments
Prazo: Up to 4 weeks post-chemoradiation therapy
|
This pilot study will yield preliminary data on the feasibility of activity monitoring during radiotherapy as well as possible associations between activity level and various clinical and treatment-related variables.
Data from the study will be summarized using standard descriptive statistics; means and standard deviations will be used for normally-distributed continuous variables, and frequencies and percentages will be used for categorical variables.
Exploratory analyses for associations between activity levels and clinical and treatment-related variables will be performed using chi-square o
|
Up to 4 weeks post-chemoradiation therapy
|
Number of patients who successfully use the activity monitor (i.e. wearing the activity monitor throughout the treatment course)
Prazo: Up to 4 weeks post-chemoradiation therapy
|
This pilot study will yield preliminary data on the feasibility of activity monitoring during radiotherapy as well as possible associations between activity level and various clinical and treatment-related variables.
Data from the study will be summarized using standard descriptive statistics; means and standard deviations will be used for normally-distributed continuous variables, and frequencies and percentages will be used for categorical variables.
Exploratory analyses for associations between activity levels and clinical and treatment-related variables will be performed using chi-square o
|
Up to 4 weeks post-chemoradiation therapy
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Nitin Ohri, Albert Einstein College of Medicine
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
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
- 2015-4873 (Outro identificador: Albert Einstein College of Medicine)
- P30CA013330 (Concessão/Contrato do NIH dos EUA)
- NCI-2015-02292 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- 007067
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 .
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