Mantendo hábitos saudáveis (HABITS)
26 de setembro de 2025 atualizado por: University of Tennessee
Mantendo hábitos saudáveis: intervenções de contato estendido para promover atividade física de longo prazo em sobreviventes de câncer afro-americanos
O objetivo deste projeto é ajudar a aumentar a manutenção da atividade física em sobreviventes de câncer que são mais propensos a enfrentar disparidades de saúde e desvantagens sociais.
Visão geral do estudo
Status
Recrutamento
Descrição detalhada
O objetivo do estudo é avaliar novas intervenções destinadas a ajudar mulheres sobreviventes do câncer, que se identificam como afro-americanas ou negras, a superar barreiras ao exercício, desenvolver uma mentalidade fisicamente ativa e estabelecer hábitos de exercício necessários para praticar exercícios a longo prazo.
Essas novas intervenções são 1.
Mensagens de texto (SMS), 2. Coaching de pares, 3. Combinação de coaching de pares e SMS, 4. Cuidados habituais
Tipo de estudo
Intervencional
Inscrição (Estimado)
260
Estágio
- Não aplicável
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.
Contato de estudo
- Nome: Michelle Martin, PhD
- Número de telefone: 901-448-2383
- E-mail: mmart126@uthsc.edu
Estude backup de contato
- Nome: Talia Williams, BA
- Número de telefone: 901-448-8682
- E-mail: twill213@uthsc.edu
Locais de estudo
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- Recrutamento
- University of Alabama at Birmingham
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Contato:
- Laura Rogers, MD, MPH
- Número de telefone: 205-934-9735
- E-mail: lqrogers@uabmc.edu
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Contato:
- Ildiko Nyikos, MA, ACSM-RCEP, EIM-3
- Número de telefone: 205-975-0002
- E-mail: inyikos@uabmc.edu
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Investigador principal:
- Laura Rogers, MD, MPH
-
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38163
- Recrutamento
- University of Tennessee Health Science Center
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Contato:
- Michelle Martin, PhD
- Número de telefone: 901-448-2383
- E-mail: mmart126@uthsc.edu
-
Contato:
- Talia Williams, BA
- Número de telefone: 901-448-8682
- E-mail: twill213@uthsc.edu
-
Investigador principal:
- Michelle Martin,, PhD
-
-
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
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Critérios de inclusão:
- mulher com 19 anos ou mais
- se identifica como afro-americano ou negro
- tem histórico de câncer
- completaram o tratamento pós-primário para câncer (ou seja, quimioterapia, radiação)
- concorda em permitir que a equipe de pesquisa confirme o diagnóstico de câncer com seu médico
- Se for submetido a cirurgia, deve ser pelo menos 8 semanas após a cirurgia
- disposto a que um médico regular forneça autorização médica para participação no estudo
- disposto a fornecer endereço residencial se qualificado para o estudo
- disposto e capaz de usar plataforma de videoconferência como Zoom para atividades de estudo (deve estar disposto e capaz)
- disposto e capaz de enviar e/ou receber mensagens de texto (deve estar disposto e capaz)
- tem número de telefone dos EUA
- tem um endereço de e-mail
- se não tiver endereço de e-mail, deve estar disposto a criar um
- Falando inglês
- Capaz de deambular sem ajuda (não precisa usar bengala, andador ou cadeira de rodas)
- disposto e capaz de completar 3-5 sessões de exercícios por semana por conta própria durante o estudo; se a resposta for não, explique
- disposto a participar de sessões individuais e em grupo por meio de videoconferências durante a participação no estudo; se a resposta for não, explique.
- disposto a participar das avaliações por videoconferência durante a participação no estudo; se a resposta for não, explique.
- disposto a responder pesquisas durante a participação no estudo; se a resposta for não, explique.
Critérios de exclusão:
- Câncer metastático ou recorrente
- outro diagnóstico de câncer nos últimos 5 anos (não incluindo câncer de pele ou cervical in situ)
- tem problemas ortopédicos, articulares graves ou qualquer outra condição que impeça o indivíduo de ser ativo
- angina instável
- sentir dor, aperto ou peso no peito, QUANDO em repouso OU quando fisicamente ativo
- tem insuficiência cardíaca congestiva classe II, III, OR IV da New York Heart Association
- a pressão arterial esteve acima de 160/100 pelo menos duas vezes nos últimos 6 meses (qualquer número; 160 ou 100)
- tem asma não controlada
- tem doença pulmonar intersticial que requer oxigênio extra
- tem demência ou síndrome cerebral organizada
- tem esquizofrenia ou psicose ativa
- teve um acidente vascular cerebral ou outro problema que deixou o indivíduo incapacitado ou com paralisia (incapaz de mover ou sentir qualquer parte do corpo)
- tem problemas auditivos que dificultam a conversa telefônica
- cego ou parcialmente cego
- cirurgia planejada durante os primeiros 6 meses de participação no estudo (se não for aprovada pelo PI)
- cirurgia planejada de joelho ou quadril durante os primeiros 6 meses de participação no estudo
- antecipar mudanças nos medicamentos habituais durante os primeiros 6 meses de participação no estudo (se não for aprovado pelo PI)
- foram informados por um médico para fazer apenas exercícios prescritos por um médico
- foram informados por um médico para limitar a atividade física
- tem contra-indicação para praticar exercícios aeróbicos de intensidade moderada
- completaram, em média, mais de 90 minutos/semana de exercícios de intensidade moderada ou mais de 30 minutos/semana de exercícios vigorosos nos últimos 6 meses
- problemas com equilíbrio ou movimentação segura
- estão grávidas ou preveem engravidar durante a participação no estudo
- atualmente participando de outro estudo de exercícios
- ter IMC ≥ 50
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
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Coach de pares e SMS
Intervenções de SMS e de treinadores de pares focadas na manutenção da atividade física
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A intervenção do Sistema de Mensagens Curtas (SMS) concentra-se em mensagens SMS personalizadas e adaptativas que ajudam o participante a manter comportamentos de atividade física.
O treinador de pares realizará uma intervenção que ajudará os participantes a manter a atividade física.
|
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Experimental: Treinador de pares
Intervenção do peer coach focada na manutenção da atividade física
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O treinador de pares realizará uma intervenção que ajudará os participantes a manter a atividade física.
Outros nomes:
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Experimental: Serviço de mensagens curtas (SMS)
Intervenção SMS focada na manutenção da atividade física
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A intervenção do Sistema de Mensagens Curtas (SMS) concentra-se em mensagens SMS personalizadas e adaptativas que ajudam o participante a manter comportamentos de atividade física.
Outros nomes:
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Outro: Cuidados habituais
Materiais escritos com foco na manutenção da atividade física
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Os participantes receberão materiais escritos com conselhos sobre como manter sua atividade física.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Atividade Física (resultado relatado pelo paciente)
Prazo: Da linha de base até a avaliação de 15 meses
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Os participantes usarão sensor de movimento na cintura por 7 dias
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Da linha de base até a avaliação de 15 meses
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Fadiga (resultado relatado pelo paciente)
Prazo: Na linha de base, avaliação de 3 meses, avaliação de 9 meses e avaliação de 15 meses.
|
A fadiga será medida usando a escala do Inventário de Sintomas de Fadiga (intensidade e interferência da fadiga).
|
Na linha de base, avaliação de 3 meses, avaliação de 9 meses e avaliação de 15 meses.
|
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Saúde autopercebida (resultado relatado pelo paciente)
Prazo: Na linha de base, avaliação de 3 meses, avaliação de 9 meses e avaliação de 15 meses.
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A autopercepção da saúde será medida por meio do questionário EQ-5D.
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Na linha de base, avaliação de 3 meses, avaliação de 9 meses e avaliação de 15 meses.
|
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Qualificação de vida (resultado relatado pelo paciente)
Prazo: Na linha de base, avaliação de 3 meses, avaliação de 9 meses e avaliação de 15 meses.
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A qualidade de vida será medida por meio do questionário PROMIS Global Health.
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Na linha de base, avaliação de 3 meses, avaliação de 9 meses e avaliação de 15 meses.
|
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Ansiedade e Depressão (resultado relatado pelo paciente)
Prazo: Na linha de base, avaliação de 3 meses, avaliação de 9 meses e avaliação de 15 meses.
|
A ansiedade e a depressão serão medidas usando a Escala Hospitalar de Ansiedade e Depressão.
|
Na linha de base, avaliação de 3 meses, avaliação de 9 meses e avaliação de 15 meses.
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Estresse (resultado relatado pelo paciente)
Prazo: Na linha de base, 3 meses, 9 meses e 15 meses
|
O estresse será medido usando a Escala de Estresse Percebido
|
Na linha de base, 3 meses, 9 meses e 15 meses
|
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Determinantes Sociais da Saúde
Prazo: Na linha de base, 3 meses, 9 meses, 15 meses
|
Os determinantes sociais da saúde serão medidos por meio do questionário dos Determinantes Sociais da Saúde (SDoH).
|
Na linha de base, 3 meses, 9 meses, 15 meses
|
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Big Five Personalidade (resultado relatado pelo paciente)
Prazo: Na linha de base, 3 meses, 9 meses, 15 meses
|
A personalidade dos cinco grandes será medida usando uma versão resumida do questionário Big Five Personality Inventory.
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Na linha de base, 3 meses, 9 meses, 15 meses
|
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Autorrelato de atividade física
Prazo: Na linha de base, 3 meses, 9 meses, 15 meses
|
Os exercícios aeróbicos e de resistência serão medidos por meio do questionário Godin Aerobic Strength.
|
Na linha de base, 3 meses, 9 meses, 15 meses
|
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Qualidade de vida (resultado relatado pelo paciente)
Prazo: Na linha de base, 3 meses, 9 meses, 15 meses
|
A qualidade de vida será medida por meio do questionário EQ-5D-5L.
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Na linha de base, 3 meses, 9 meses, 15 meses
|
|
Apoio Social para Atividade Física (resultado relatado pelo paciente)
Prazo: Na linha de base, 3 meses, 9 meses, 15 meses
|
O apoio social para atividade física será medido por meio do questionário de Apoio Social para AF.
|
Na linha de base, 3 meses, 9 meses, 15 meses
|
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Processos reflexivos, regulatórios e reflexivos (resultado relatado pelo paciente)
Prazo: Linha de base, 3 meses, 6 meses, 9 meses, 12 meses, 15 meses
|
Os processos reflexivos, regulatórios e reflexivos estão sendo medidos pelo questionário de atividade física M-PAC.
|
Linha de base, 3 meses, 6 meses, 9 meses, 12 meses, 15 meses
|
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Interferência percebida das barreiras ao exercício
Prazo: Na linha de base, 3 meses, 9 meses, 15 meses
|
As barreiras ao exercício serão medidas usando o questionário Barreiras Percebidas ao Exercício.
|
Na linha de base, 3 meses, 9 meses, 15 meses
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Michelle Martin, PhD, University of Tennessee
- Investigador principal: Laura Rogers, MD, MPH, University of Alabama at Birmingham
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
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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)
27 de janeiro de 2025
Conclusão Primária (Estimado)
31 de março de 2028
Conclusão do estudo (Estimado)
31 de março de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
17 de dezembro de 2024
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de dezembro de 2024
Primeira postagem (Real)
20 de dezembro de 2024
Atualizações de registro de estudo
Última Atualização Postada (Estimado)
1 de outubro de 2025
Última atualização enviada que atendeu aos critérios de controle de qualidade
26 de setembro de 2025
Última verificação
1 de setembro de 2025
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB-300011855
- R01MD018375 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Indivíduos interessados em solicitar DPI deverão entrar em contato com os PIs do estudo.
Prazo de Compartilhamento de IPD
Depois que o gerenciamento de dados for finalizado (e os dados bloqueados) e o manuscrito relatando os dados de manutenção da atividade física no mês 15 tiver sido enviado
Critérios de acesso de compartilhamento IPD
Será necessário um acordo de uso de dados entre a instituição que hospeda os dados (UTHSC) e a instituição do pesquisador solicitante.
Tipo de informação de suporte de compartilhamento de IPD
- CIF
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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 .