Intervenção do Yoga Diádico para a Melhoria da Utilização de Cuidados de Saúde e Qualidade de Vida em Pacientes com Câncer de Cabeça e Pescoço Submetidos a Quimiorradiação e seus Cuidadores
Melhorando a utilização de cuidados de saúde e a qualidade de vida em pacientes com câncer de cabeça e pescoço submetidos a quimiorradiação e seus cuidadores familiares
This study evaluates if partner-based (dyadic) yoga programs may improve the quality of life of patients with head and neck cancer undergoing chemoradiation and their caregivers, and if it is a cost-effective option. Yoga programs may decrease how often patients come to the hospital during and after treatment with chemoradiation, and improve the quality of life for both patients and caregivers.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
PRIMARY OBJECTIVES:
I. Examine the efficacy of the dyadic yoga (DY) intervention regarding reduced patient emergency department (ED) visits and feeding tube (FT) insertions and improved patient and caregiver quality of life (QOL) as compared to the usual care (UC) group.
II. Estimate intervention costs, direct medical costs, indirect costs (i.e., productivity loss), and evaluate the overall cost-effectiveness of the DY intervention for patients and caregivers.
III. Demonstrate that, compared to the UC group, the DY program improves patient and caregiver symptoms burden, objective physical function, and illness communication and reduces patient use of opioids during chemoradiotherapy (CRT), which will in turn mediate intervention outcomes at the follow-up assessments.
IV. Understand the patient and caregiver experience of head and neck cancer (HNC), healthcare utilization and symptom management and emerging themes as possible mediators as they relate to or suggest modifications of our proposed model using qualitative methods.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Patients and caregivers receive standard care including education pertaining to symptom management, prophylactic dental hygiene and possible extraction, speech pathology for baseline swallowing assessment and prophylactic treatment, and dietary services for regular nutrition consults during CRT. Psychiatry, social work, interventional radiology and supportive care services are consulted as needed.
ARM II: Patients and caregivers receive standard care as in arm I. Patients and caregivers also participate in yoga sessions 3 times per week over 60 minutes each for a total of 15 sessions.
After completion of study, participants are followed up every 2 weeks for 3 months and then monthly for up to 6 months.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Texas
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Houston, Texas, Estados Unidos, 77030
- M D Anderson Cancer Center
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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:
- PATIENTS: Diagnosed with a primary HNC and going to receive at least 5 weeks (25 fractions) of CRT
- PATIENTS: Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- PATIENTS: Having a family caregiver (e.g., spouse/partner, sibling, adult child) willing to participate
- PATIENTS AND CAREGIVERS: Must be at least 18 years old
- PATIENTS AND CAREGIVERS: Able to read and speak English
- PATIENTS AND CAREGIVERS: Able to provide informed consent
Exclusion Criteria:
- PATIENTS AND CAREGIVERS: Who have regularly (self-defined) participated in a yoga program in the year prior to diagnosis
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Arm I (Standard of care)
Patients and caregivers receive standard care including education pertaining to symptom management, prophylactic dental hygiene and possible extraction, speech pathology for baseline swallowing assessment and prophylactic treatment, and dietary services for regular nutrition consults during CRT. Psychiatry, social work, interventional radiology and supportive care services are consulted as needed. |
Ancillary studies Receive standard care
Outros nomes:
|
|
Outro: Arm II (exercise, yoga sessions)
Patients and caregivers receive standard care as in arm I. Patients and caregivers also participate in yoga sessions 3 times per week over 60 minutes each for a total of 15 sessions. |
Ancillary studies Receive standard care
Outros nomes:
Participate in yoga sessions |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patient healthcare utilization (Standard of care)
Prazo: Up to 6 months with 3 months follow-up
|
Will examine group differences in patient emergency department visit (yes/no) during the observation period of during and up to 3 months post chemoradiotherapy (CRT) as the primary outcome. Will use logistic regression with the randomization factors as covariates, as these factors may be associated with the study outcomes, and controlling for them is likely to increase the power to detect the between-group differences. |
Up to 6 months with 3 months follow-up
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Caregiver quality of life questionnaire (RAND 36-Item Health Survey)
Prazo: Up to 6 months with 3 months follow-up
|
Will examine group differences over the 6-month follow-up period specifying the T4 as the primary endpoint using a dyadic model (assuming additional dependence in outcomes between patient and caregiver outcomes). This analysis will be imbedded in a linear mixed-effects (alternatively known as the multilevel) model analysis, with repeated measures over time (i.e., at end of CRT, 1-, 3- and 6-month follow-ups). In the mixed models, group will be entered as a primary variable of interest and baseline level of the outcome will be treated as a covariate. Participants Energy/Fatigue level-(0-lowest energy level/ 100-highest energy no fatigue) |
Up to 6 months with 3 months follow-up
|
|
Patient quality of life questionnaire
Prazo: Up to 6 months with 3 months follow-up
|
Will examine group differences over the 6-month follow-up period specifying the T4 as the primary endpoint using a dyadic model (assuming additional dependence in outcomes between patient and caregiver outcomes). This analysis will be imbedded in a linear mixed-effects (alternatively known as the multilevel) model analysis, with repeated measures over time (i.e., at end of CRT, 1-, 3- and 6-month follow-ups). In the mixed models, group will be entered as a primary variable of interest and baseline level of the outcome will be treated as a covariate. Participants Energy/Fatigue level-(0-lowest energy level/ 100-highest energy no fatigue) |
Up to 6 months with 3 months follow-up
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kathrin Milbury, M.D. Anderson Cancer Center
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2020-0311
- 2020-0311 (Outro identificador: M D Anderson Cancer Center)
- NCI-2020-13884 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- R01CA247307 (Concessão/Contrato do NIH dos EUA)
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