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- Ensaio Clínico NCT05258526
Home Based Exercise for Patients With Breast or Prostate Cancer (The BENEFIT-CA Study) (BENEFIT-CA)
Home Based Exercise for Patients With Breast or Prostate Cancer During Treatment: a Feasibility Trial (The BENEFIT-CA Study)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This feasibility trial aims to assess a home-based exercise program, including a 3-month intervention of structured physical activity and health education for individuals with breast or prostate cancer. The main objective of this trial is to assess the adherence of cancer patients to a program of structured exercise, mixed with a health education approach, implemented and accompanied in a remote approach.
The data collection will include variables related to: (a) recruitment and retentions rates; (b) attendance to exercise sessions; (c) fatigue and quality of life levels; (d) functional capacity levels; (e) adverse events related or not to the study; (f) patient selected outcomes.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Daniel Umpierre de Moraes, PhD
- Número de telefone: 555133596332
- E-mail: danielumpierre@hcpa.edu.br
Estude backup de contato
- Nome: Larissa Xavier Neves da Silva, Master
- Número de telefone: 555133596332
- E-mail: larissaxns@gmail.com
Locais de estudo
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brasil, 90035-007
- Recrutamento
- Hospital de Clinicas de Porto Alegre
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Contato:
- Daniel Umpierre de Moraes, PhD
- Número de telefone: 555133596332
- E-mail: danielumpierre@hcpa.edu.br
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Contato:
- Larissa Xavier Neves da Silva, MSc
- Número de telefone: 555133596332
- E-mail: larissaxns@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- eighteen years old minimum;
- be living in Porto Alegre or metropolitan region;
- breast cancer stage 0 - III OR
- localized prostate cancer;
- undergoing hormonal treatment / manipulation in isolation or combined with other therapies three months prior to the entrance in the study;
- hormonal therapy / manipulation planned to be active throughout the study duration;
- not engaged in any exercise training for more than once a week for the past 6 months;
- in case of previous surgical procedure, the patient must have medical clearance at the moment of the contact to begin the study or be cleared to do so in the near future (up to two weeks).
Exclusion Criteria:
- metastatic phase / progression of the disease or active regional location prior to beginning of the study;
- inability to understand the terms and conditions of study due to language, hearing, cognitive or severe psychiatric issues;
- another family member, who lives at the same residence, participating in the study;
- planning to move or major absence (more than two weeks) during the study;
- history of cardiovascular disease (except controlled hypertension) or severe cardiopulmonary disease, as well as history of heart attack, revascularization procedures, profound venous thrombosis, encephalic vascular accident (brain stroke) or pulmonary embolism in the past twelve months;
- chronic pulmonary disease that requires oxygen or corticosteroid therapy;
- kidney disease with or that is going to begin the use of dialysis or waiting for a kidney transplant;
- severe nausea, anorexia or any other condition which does not allow to perform physical exercise;
- medical contraindication to exercise training.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Home-based exercise program
This is a single study arm consisting of a home-based exercise program for individuals with breast or prostate cancer during active treatment.
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The intervention will be based on a remote approach, lasting 12 weeks.
The training routine will consist of aerobic (walking), muscle strengthening and stretching exercises, with a frequency of three days per week.
The contents related to the exercise prescription will be made available by phone call, text messages and short videos for exercise demonstration.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Trial adherence
Prazo: Up to12 weeks.
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Proportion of self-reported exercise episodes (out of 36 episodes, total) during the study.
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Up to12 weeks.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Recruitment yields
Prazo: Up to 8 weeks before allocation to the study intervention.
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Proportion of included participants (who signed the informed consent) in relation to the total number of screened individuals for eligibility.
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Up to 8 weeks before allocation to the study intervention.
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Adverse events throughout the study
Prazo: Up to 12 weeks.
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Self-reported adverse events, related or not to the study.
These measures will be mostly received by phone calls or text messaging.
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Up to 12 weeks.
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Fatigue levels at baseline and at the end of the study
Prazo: Baseline; Week 12.
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Fatigue scores using specific questionnaires of Functional Assessment of Cancer Therapy (FACT questionnaire) for breast or prostate cancer patients.
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Baseline; Week 12.
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Quality of life, based on the Functional Assessment of Cancer Therapy (FACT questionnaire)
Prazo: Baseline; Week 12.
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Quality of life scores using specific questionnaires of FACT (Functional Assessment of Cancer Therapy) for breast or prostate cancer patients.
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Baseline; Week 12.
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Walking capacity
Prazo: Baseline; Week 12.
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Total distance (in meters) performed during the six minute walk test.
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Baseline; Week 12.
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Handgrip strength
Prazo: Baseline; Week 12.
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Maximum strength (in kgf) achieved by both hands in a handgrip test using a hand dynamometer.
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Baseline; Week 12.
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Abdominal circumference
Prazo: Baseline; Week 12.
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Anthropometric measure of the highest abdominal circumference, using a metallic measuring tape.
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Baseline; Week 12.
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Physical activity levels
Prazo: Single assessment at baseline.
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Physical activity calculated in minutes and intensity per week, of physical activity using the International Physical Activity Questionnaire (IPAQ).
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Single assessment at baseline.
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Patient selected outcomes
Prazo: Week 12.
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Through the development of the study, participants will be asked to engage in a focal group to discuss outcomes relevant to be assessed in trials with exercise interventions targeted for patients with breast or prostate cancer.
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Week 12.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Daniel Umpierre de Moraes, PhD, Hospital de Clinicas de Porto Alegre
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2021-0262
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Files will be as de-identified as possible before public data sharing. After data protection and data handling routines, de-identified data will be readily available to all project contributors. We consider research data gathered from data collection from research participants pertains primarily to these individuals. Therefore, all individual data will be available to their owners throughout the project. Structured data that will result from this research project will pertain to the PI (Daniel Umpierre), who will be responsible for data integrity, and to the institution (Hospital de Clinicas de Porto Alegre).
The specific structure for data sharing as well as plataforms are still to be defined. As soon, we define the remaining details of our data sharing strategy the IPD plan will be updated.
Prazo de Compartilhamento de IPD
Due to space and management constraints, we are planning:
- To retain and store project documentation (informed consents, IRB communication, subjects' communication) for at least 10 years after the study completion (anticipated time: up to 2033).
- To retain and share project resources (instruments, intervention materials) as long as public repositories (e.g., Zenodo, OSF, figshare) provide sharing services at no cost.
- To retain and share datasets as long as public repositories (e.g., Zenodo, OSF, figshare) provide sharing services at no cost.
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- Protocolo de estudo
- Termo de Consentimento Livre e Esclarecido (TCLE)
- Relatório de Estudo Clínico (CSR)
- Código Analítico
Informações sobre medicamentos e dispositivos, documentos de estudo
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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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