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Cognitive Support Program for Patients With Brain Metastases

15 de abril de 2019 atualizado por: University Health Network, Toronto
This study evaluates the feasibility and preliminary efficacy of a brief cognitive-behavioural program designed to improve cognitive functioning in people with brain metastases.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Cognitive impairments (such as problems with attention, executive functions, memory and language abilities) are common in people with brain metastases as a result of disease and/or treatment effects. These impairments can significantly limit functional independence, participation in valued roles and activities, and overall quality of life.

Building on research in other cognitively-impaired populations, we designed a brief, structured, patient-centered Cognitive Support Program (CSP) for brain metastases patients, who have the option of participating with a caregiver. Program contents include supportive psychoeducation, mindfulness practice, and strategy training (e.g., strategies to improve memory or concentration). This prospective, single-arm study will enroll 24 brain metastases patients to evaluate the feasibility and preliminary efficacy of the CSP. A battery of outcome measures is administered (1) prior to intervention, (2) after completing the CSP, and (3) after an additional 3 months to evaluate longer-term outcomes. Feasibility assessment will include program retention and adherence. Reliable change analyses will examine treatment effects, with regression analyses to explore moderating effects of select patient, disease and treatment factors (e.g., severity of baseline cognitive impairment, number of brain lesions, cranial radiation dose and distribution). Results of this trial will inform further development and implementation of evidence-based supportive care for cognitively-impaired brain metastases patients.

Tipo de estudo

Intervencional

Inscrição (Real)

18

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.

Locais de estudo

  • Canadá
    • Ontario
      • Toronto, Ontario, Canadá, M5S1W8
        • Princess Margaret Cancer Centre

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

18 anos a 90 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • age 18 or older
  • able to provide informed consent to all procedures
  • diagnosis of one or more brain metastases, with primary cancer outside the CNS
  • indication of cognitive deficits from self-report and/or cognitive testing
  • interest in participating in a cognitive rehabilitation program
  • able to complete study activities

Exclusion Criteria:

  • concurrent non-cancer-related neurological or major psychiatric disorder or other medical condition suspected to influence cognition

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: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Cognitive Support Program
Three individual sessions of supportive psychoeducation, mindfulness practice, and strategy training (e.g., strategies to improve memory or concentration), with practice applying program content between sessions.
Comportamental: Cognitive Support Program
Three individual sessions of supportive psychoeducation, mindfulness practice, and strategy training (e.g., strategies to improve memory or concentration), with practice applying program content between sessions.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Functional Assessment of Cancer Therapy - Cognitive
Prazo: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Multi-domain cognitive symptom questionnaire completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Frontal Systems Behavior Scale
Prazo: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Executive cognitive symptom questionnaire completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Hopkins Verbal Learning Test - Revised
Prazo: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Neurocognitive test of memory completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Trail Making Test
Prazo: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Neurocognitive test of processing speed and executive function completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Wechsler Digit Span Test
Prazo: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Neurocognitive test of working memory completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
BADS Zoo Map Test
Prazo: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Neurocognitive test of executive function completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Controlled Oral Word Association Test
Prazo: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Neurocognitive test of verbal fluency completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Functional Assessment of Cancer Therapy - Brain
Prazo: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Health-related quality of life questionnaire completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Positive and Negative Affect Schedule
Prazo: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Quality of life (well-being) questionnaire completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Hospital Anxiety and Depression Scale
Prazo: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Quality of life (psychological distress) questionnaire completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Illness Intrusiveness Rating Scale
Prazo: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Quality of life (activity participation) questionnaire completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University Health Network, Toronto

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)

1 de julho de 2017

Conclusão Primária (Real)

28 de novembro de 2018

Conclusão do estudo (Real)

28 de novembro de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

21 de abril de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de maio de 2018

Primeira postagem (Real)

25 de maio de 2018

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de abril de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de abril de 2019

Última verificação

1 de abril de 2019

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 16-6056

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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 .

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