Living Well With Brain Cancer: A Group-Based Intervention to Promote Whole-Person Well-Being (LWBC)
2 de junho de 2026 atualizado por: University of Colorado, Denver
Pilot Study of the Living Well With Brain Cancer Intervention
The goal of this clinical trial is to learn if the newly designed group self-management program is feasible to conduct and improves mental and behavioral health outcomes compared to a control group in people diagnosed with brain cancer. The main questions it aims to answer are:
- Is it feasible to conduct this program?
- Does the new group self-management program improve behavioral health outcomes more than in the control group that will not be in a group setting?
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
64
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: Research Services Professional
- Número de telefone: 303-724-1723
- E-mail: lwbc@cuanschutz.edu
Locais de estudo
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- University of Colorado Anschutz
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Contato:
- Research Services Professional
- E-mail: LWBC@cuanschutz.edu
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Investigador principal:
- Bethany M Kwan, PhD, MSPH
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Ohio
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Cleveland, Ohio, Estados Unidos, 44106
- University Hospitals Cleveland Medical Center
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Investigador principal:
- Molly McVoy, MD
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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
Inclusion Criteria:
- Currently living in the United States
- Aged 18 years or older
- Confirmed diagnosis of a malignant brain tumor including diffuse gliomas, World Health Organization (WHO) grades II, III, and IV (either by directly sharing their pathology report or confirmation from their prescribing treating provider)
- Treating prescribing provider who follows regularly with participant
Exclusion Criteria:
- <1 month since initial diagnosis and/or <1 month since surgical resection
- Enrollment in hospice
- Significant physical or cognitive disabilities that prohibit involvement using our clinician's judgement as a self-management expert, with consultation with personal clinician if needed
- Currently receiving psychiatric treatment for a serious mental illness (e.g., schizophrenia)
- Not able to communicate in English at a conversational level
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 Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Group Self-Management Arm
Participants in the intervention arm will attend eight 90-minute virtual group sessions with nurse and peer educators that will navigate them through the different self-management content.
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Our targeted self-management intervention will be delivered virtually through eight 90-minute sessions over a 3-4-month period using materials adapted from previous focus groups of people with brain cancer and an expert design panel.
A nurse educator and peer educator will facilitate the virtual sessions.
The content covers topics focused on how to improve the quality of life in people diagnosed with brain cancer.
Outros nomes:
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Comparador Ativo: Education Only Arm
Participants in this arm will be invited to use an online learning management system to access the educational materials.
There are no group sessions, and there are no nurse or peer educators that will lead the participants through the materials.
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Self-management content specifically designed for people with brain cancer will be uploaded into a learning management system.
The content will be broken up into modules that will be unlocked at the same frequency as the self-management group sessions arm.
There are no group sessions involved, and there are no nurse or peer educators to lead the participants through this content.
Outros nomes:
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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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Change from Baseline of Overall Score from the RAND 36-Item Short Form Survey Instrument (SF-36)
Prazo: Baseline, immediately post-intervention, and 3 months post-intervention
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Evaluated by the change overall score of the RAND 36-Item Short Form Survey Instrument (SF-36) at baseline, immediate after intervention, and 3 months post-intervention
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Baseline, immediately post-intervention, and 3 months post-intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline in Score of NIH Toolbox Item Bank v3.0 - Perceived Stress
Prazo: Baseline and immediately post-intervention
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Change from Baseline to immediately after intervention in score of NIH Toolbox Item Bank v3.0 - Percevied Stress (Ages 18+) - Fixed Form
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Baseline and immediately post-intervention
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Change from Baseline in Score of Neuro-QOL Item Bank v1.0 - Positive Affect and Well-Being
Prazo: Baseline and immediately post-intervention
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Change from baseline to immediately post-intervention in score of Neuro-QOL Item Bank v1.0 - Positive Affect and Well-Being
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Baseline and immediately post-intervention
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Change from Baseline of score from Neuro-QOL Item Bank v1.0 - Depression
Prazo: Baseline and immediately post-intervention
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Change from baseline to immediately post-intervention of score from the Neuro-QOL Item Bank v1.0 - Depression survey
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Baseline and immediately post-intervention
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Change from Baseline in Score from Neuro-QOL Item Bank v1.0 - Fatigue - Short Form
Prazo: Baseline and immediately post-intervention
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Change from baseline to immediately post-intervention in score from Neuro-QOL Item Bank v1.0 Fatigue - Short Form survey
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Baseline and immediately post-intervention
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Overall Score from Neuro-QOL Item Bank v1.0 - Upper Extremity Function and Lower Extremity Function
Prazo: Baseline
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Score evaluated at baseline from the Neuro-QOL Item Bank v1.0 - Upper Extremity Function and Lower Extremity Function surveys
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Baseline
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Overall score from Neuro-QOL Item Bank v1.0 - Cognitive Function - Short Form and Emotional and Behavioral Dyscontrol - Short Form
Prazo: Baseline
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Baseline overall score from the Neuro-QOL Item Bank v1.0 - Cognitive Function - Short Form and Emotional and Behavioral Dyscontrol - Short Form surveys
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Baseline
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Change from Baseline in Score from Neuro-QOL Item Bank v1.1 - Satisfaction with Social Roles and Activities - Short Form
Prazo: Baseline and immediately post-intervention
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Change in score from baseline to immediately post-intervention of the Neuro-QOL Item Bank v1.1 - Satisfaction with Social Roles and Activites - Short Form survey
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Baseline and immediately post-intervention
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Change from Baseline in Score from Neuro-QOL Item Bank v1.0 - Sleep Disturbance - Short Form
Prazo: Baseline and immediately post-intervention
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Change in score from baseline to immediately post-intervention from the Neuro-QOL Item Bank v1.0 - Sleep Disturbance - Short Form survey
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Baseline and immediately post-intervention
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Change from Baseline of Score from PROMIS Item Bank v1.0 - Self Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8a
Prazo: Baseline and immediately post-intervention
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Change in score from baseline to immediately post-intervention from the PROMIS Item Bank v1.0 - Self Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8a survey
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Baseline and immediately post-intervention
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Survival
Prazo: Immediate post-intervention, 3 months post-intervention
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Self/contact-reported survival
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Immediate post-intervention, 3 months post-intervention
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Bethany M Kwan, PhD, MSPH, University of Colorado, Denver
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 (Estimado)
1 de junho de 2026
Conclusão Primária (Estimado)
31 de outubro de 2027
Conclusão do estudo (Estimado)
31 de outubro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
26 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de junho de 2026
Primeira postagem (Real)
5 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
5 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de junho de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Neoplasias por local
- Neoplasias
- Neoplasias por Tipo Histológico
- Neoplasias Glandulares e Epiteliais
- Neoplasias Neuroepiteliais
- Tumores Neuroectodérmicos
- Neoplasias, Células Germinativas e Embrionárias
- Neoplasias, Tecido Nervoso
- Neoplasias do Sistema Nervoso
- Neoplasias do Sistema Nervoso Central
- Comportamento
- Satisfação pessoal
- Glioblastoma
- Glioma
- Neoplasias Cerebrais
- Astrocitoma
- Ependimoma
- Oligodendroglioma
- Bem-estar psicológico
Outros números de identificação do estudo
- 25-2124
- HT9425-24-1-0883 (Número de outro subsídio/financiamento: U.S. Army Medical Research Acquisition Activity (USAMRAA))
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
The datasets generated during and/or analyzed during the current study will not be publicly available, but will be available from the primary investigator on reasonable request.
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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