- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00815152
Coping With High Grade Glioma
Purpose and Objective:
To determine the feasibility and short- and long-term efficacy of an empirically-based CST intervention (Keefe et al.) with caregivers of patients with primary malignant brain cancer.
Study Activities and Population Group:
The target sample will be 20 caregiver-patient dyads. Using a randomized controlled, prospective design, potentially eligible participants will be identified at the time of initial consultation (see Figure 1). Outcomes will be assessed at baseline, post-intervention (3 months post-randomization), 6 months post-randomization, and every 4 months up to 2-years in the event that the patient dies.
- Data Analysis and Risk/Safety Issues:
With only 10 subjects per group we do not have statistical power for direct hypothesis testing. Nevertheless, p-values will be presented for some analyses (chi-square tests, t-tests, and Spearman correlations) simply to aid in interpretation of results. In no way will these p-values be used to declare statistical significance or non-significance of the test results. Accordingly, the primary focus will be the means, variances, and covariances of the study endpoints, as well as the change scores in these endpoints across the study intervention and their 95% confidence limits.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The purpose of this study is to determine the feasibility and short- and long-term efficacy of an empirically-based CST intervention (Keefe et al.) with caregivers of patients with primary malignant brain cancer. The target sample will be 20 caregiver-patient dyads. The caregiver may be a spouse/partner, family member or friend,. Additional inclusion criteria will include: (1) caregiver provides a weekly minimum of 4 hours of caregiving; (2) caregiver is 18 years or older; (3) caregiver reading level at or above 8th grade; (4) caregiver sufficiently fluent in English; (5) the patient shows evidence of problems in depression, fatigue, sleep disturbance, and/or cognitive impairment as per the treating neuro-oncologist; (6) the caregiver and patient are willing to be randomized to treatment or usual care condition; (7) patient is within 3 months of initial diagnosis; (8) patient has life expectancy of at least 6 months or more; (9) the caregiver is willing to participate in treatment sessions using a telephone. If a patient dies during the active 12-week study phase, then the caregiver will be transitioned to the follow-up phase or removed from the study and, if needed, be referred for appropriate psychiatric or psychological treatment.
Using a randomized controlled, prospective design, potentially eligible participants will be identified at the time of initial consultation. Outcomes will be assessed at baseline, post-intervention (3 months post-randomization), 6 months post-randomization, and every 4 months up to 2-years in the event that the patient dies. If the subject is assigned to the intervention, they will be asked to complete 12 weeks of a coping skills training intervention. The coping skills intervention will consist of six telephone conversations during which they will learn strategies to reduce stress. The strategies will include ways to improve problem solving, communication skills, and managing activities. The subject will also be asked to complete a packet of questionnaires which will take about 1 hour to do. The subject will be asked to complete the questionnaires multiple times during the study (before the coping skills intervention, during the week after the coping skills intervention, and 3 months after the coping skills intervention). If the subject is assigned to the usual care condition, they will be asked to complete assessments at the same time intervals as caregivers in the active coping skills intervention. In either condition, in the event that the patient dies, the caregiver will also be asked to complete assessments every four months for one year. Patients will be asked to participate in sessions and complete questionnaires as they are able to.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- The Preston Robert Tisch Brain Tumor Center at Duke
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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:
The caregiver may be a spouse/partner, family member or friend. Additional inclusion criteria will include:
- caregiver provides a weekly minimum of 4 hours of caregiving;
- caregiver is 18 years or older;
- caregiver reading level at or above 8th grade;
- caregiver sufficiently fluent in English;
- the patient shows evidence of problems in depression, fatigue, sleep disturbance, and/or cognitive impairment as per the treating neuro-oncologist;
- the caregiver and patient are willing to be randomized to treatment or usual care condition;
- patient is within 3 months of initial diagnosis;
- patient has life expectancy of at least 6 months or more;
- the caregiver is willing to participate in treatment sessions using a telephone. If a patient dies during the active 12-week study phase, then the caregiver will be transitioned to the follow-up phase or removed from the study and, if needed, be referred for appropriate psychiatric or psychological treatment.
Exclusion Criteria:
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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 |
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Experimental: 1
Twenty five caregivers will randomly be assigned to receive active coping skills training and 25 caregivers will randomly receive usual care at The Preston Robert Tisch Brain Tumor Center at Duke.
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The strategies will include ways to improve problem solving, communication skills, and managing activities.
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Comparador de Placebo: 2
Caregivers that will receive ususal care.
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The ususal care at the Preston Robert Tisch Brain Tumor Center
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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To explore the effects of a coping skills training (CST) intervention on distress, self-efficacy and other related outcomes among caregivers of high grade glioma patients.
Prazo: 2 years
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2 years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Bart Brigidi, PhD, Duke University
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 (Estimativa)
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
- Pro00012826
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