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O estudo clínico NCT06213571 para Adenocarcinoma Endometrioide Endometrial Grau 1 FIGO, Adenocarcinoma Endometrioide Endometrial Grau 2 FIGO, Câncer do corpo uterino estágio IA AJCC v8, Câncer de corpo uterino estágio IB AJCC v8 está ativo, não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Clínica MaioRemote Home-Based Exercise Program for Strength Training in Endometrial Cancer Survivors in Rural Areas
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06213571 é um ensaio intervencionista para Adenocarcinoma Endometrioide Endometrial Grau 1 FIGO, Adenocarcinoma Endometrioide Endometrial Grau 2 FIGO, Câncer do corpo uterino estágio IA AJCC v8, Câncer de corpo uterino estágio IB AJCC v8. Seu status atual é: ativo, não recrutando. O estudo começou em 22 de março de 2024 e pretende incluir 80 participantes. Coordenado por a Clínica Maio e deve ser concluído em 31 de março de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 6 de agosto de 2025.
Resumo
This clinical trial studies how well a remotely delivered home-based exercise program for strength training works to positively impact endometrial cancer (EC) survivorship for patients with decreased cancer survivorship access. Cancer survivors in rural areas face barriers to supportive care, including geographic and environmental barriers to exercise and technology. Rural areas in the Midwest are underserved in terms of cancer care thus, it is essential to develop and test interventions that are scalable and can reach many individuals including those living in rural areas. Remotely-delivered exercise intervention approach allows for cancer survivors who may live far away from their primary treatment center to engage in supportive therapy via exercise interventions delivered in a sustainable context. In addition, historically black, hispanic and native endometrial cancer survivors have shorter survival and less access to survivorship care, so alternative models for healthcare delivery are needed in this underserved group. Information gained from this research may help determine whether utilizing a remotely delivered exercise program can positively impact EC survivorship for patients with decreased cancer survivorship access.
Descrição detalhada
PRIMARY OBJECTIVES:
I. To develop and tailor a fully remote home-based exercise intervention for EC patients.
II. To test the recruitment and retention and acceptability of a fully remote home-based telehealth exercise intervention in older adult patients that live in rural America and are survivors of early stage, low risk endometrial cancer.
III. To measure the effectiveness of exercise intervention on quality of life in endometrial cancer patients, specifically in the realm of physical functioning.
OUTLINE:
Participants participate in a home-based exercise program with an exercise prescription that will include resistance band and body weight exercises targeting the 5 major large muscle groups along with 3 booklets about exercise and exercise training and attend weekly exercise coaching sessions to report on exercise adherence and to progress exercise over 10 weeks on study.
After completion of study intervention, patients are followed up at 6 months.
Título oficial
RISE: Remote Intervention for Strength Training in Endometrial Cancer
Condições
Adenocarcinoma Endometrioide Endometrial Grau 1 FIGOAdenocarcinoma Endometrioide Endometrial Grau 2 FIGOCâncer do corpo uterino estágio IA AJCC v8Câncer de corpo uterino estágio IB AJCC v8Outros IDs do estudo
- 23-008883
- NCI-2023-11096 (Identificador de registro) (CTRP (Clinical Trial Reporting Program))
- 23-008883 (Outro identificador) (Mayo Clinic in Rochester)
Número NCT
Data de início (real)
2024-03-22
Última atualização postada
2025-08-06
Data de conclusão (estimada)
2026-03-31
Inscrição (estimada)
80
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ativo, não recrutando
Propósito principal
Cuidados de suporte
Alocação do design
N/A
Modelo de intervenção
Grupo único
Cegamento (Mascaramento)
Nenhum (Estudo aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalSupportive Care (home-based exercise program) Participants participate in a home-based exercise program with an exercise prescription that will include resistance band and body weight exercises targeting the 5 major large muscle groups along with 3 booklets about exercise and exercise training and attend weekly exercise coaching sessions to report on exercise adherence and to progress exercise over 10 weeks on study. | Aconselhamento de exercícios Participate in exercise coaching sessions Intervenção de exercício Participate in home-based exercise program Promoção e educação em saúde Receive resistance band and exercise booklets Entrevista Ancillary studies Teste de desempenho físico Ancillary studies Administração de questionário Ancillary studies Telemedicina Participate in sessions remotely |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Retention of participants | Assessed by the number of patients who complete 75% or more of the twice weekly exercise program. | Up to 2 years |
Satisfaction with program - self-reported | Assessed by a simple participant satisfaction survey after completion of the 10-week exercise intervention. Qualitative interviews will be performed at the completion of the program regardless of level of participation to assess facilitators, barriers, and motivators to participation. | 10 weeks |
Feasibility of intervention | Technological questions and problems that arise during the exercise intervention will be recorded to assess the ability to fully perform telehealth exercise interventions in a rural cancer population | Up to 2 years |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Change in physical function | Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 6b assessment, a 6-item questionnaire answered on a scale from 5 (Without any difficulty or Not at all) to 0 (Unable to do or Cannot do). | Baseline; 10 weeks (end of exercise intervention); 6 months after completion of intervention |
Critérios de elegibilidade
Idades elegíveis
Adulto, Adulto mais velho
Idade mínima
50 Years
Sexos elegíveis
Feminino
- Age 50+
- Stage IA-IB endometrial cancer
- Grade 1-2 disease
- No recurrence documented
- Internet access
- Access to a remote device with a camera such as a computer, smartphone or tablet
- > 1 year but less than 5 years from surgery
- Primary residence in rural-urban commuting area (RUCA) (rural-urban commuting area) codes 4.0 through 10.0 or of American Indian, Alaskan Native, Black or Hispanic background
- Paraplegia/hemiplegia
- No English speaking
Clínica Maio868 estudos clínicos ativos para explorarSem dados de contato.
1 Locais do estudo em 1 países
Minnesota
Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States