Uma Plataforma de Automonitorização para Acompanhar a Segurança e Preocupações com a Medicação em Doentes com Cancro
Envolvimento do Paciente na Utilização da Tecnologia para Auto-monitorização de Eventos de Segurança da Medicação
This clinical trial evaluates the usefulness of a self-monitoring platform for tracking medication safety events and concerns in patients with lung, colorectal, breast, and prostate cancer. Patients receiving oral anticancer agents often encounter challenges in managing complex treatment regimens, potentially life-threatening toxicities, and drug-drug and drug-food interactions at home. To achieve the goal of medication safety, they need to become "vigilant partners" in medication and toxicity self-monitoring, including timely reporting of medication events to clinicians when their care transitions back home. In this study, patients use an online self-monitoring platform to track their experiences or concerns about taking their medications, including their experiences with symptoms. This platform may be a useful way for patients to track problems they have when taking their medications at home and may help them take better care of their health.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan Comprehensive 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:
- Participants are adult patients (aged 18 years or older)
- Diagnosed with lung, colorectal, breast, or prostate cancer
- Are currently receiving active cancer treatments
- Are self-managing one or more prescribed cancer medications
- Participants must have access to technology devices (smartphone, tablet, computer) to track their experiences or concerns about medication safety events, or their family members can help them access technology devices to track the events or concerns
- Speaks and reads English or has a support person (family member or friend) who can assist
Exclusion Criteria:
- Can't access technology or do not use technology
- Do not have access to the internet
- Do not speak or read English
- Not permitted to participate by their health care providers
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Health services research (self-monitoring platform)
Patients use the self-monitoring platform to track medication-related safety events and issues at home for 6 months. Patients may receive relevant educational materials and resources via the platform or by email and/or receive follow-up contact from a nurse practitioner as needed over the 6 months. Patients are encouraged to continue using the platform for an additional 6 months after the study period, as desired. |
Ancillary studies Ancillary studies Ancillary studies Receive educational materials and resources
Outros nomes:
Receive follow-up contact
Outros nomes:
Use self-monitoring platform |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Self-reported system usability
Prazo: Up to 6 months
|
Self-reported system usability will be assessed using the 10-item System Usability Scale. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. |
Up to 6 months
|
|
Perceived usefulness
Prazo: Up to 6 months
|
Qualitative data, including brief interview data will be analyzed and summarized through content analysis. |
Up to 6 months
|
|
Ease of use
Prazo: Up to 6 months
|
Qualitative data, including brief interview data will be analyzed and summarized through content analysis. |
Up to 6 months
|
|
Attitudes toward use
Prazo: Up to 6 months
|
Qualitative data, including brief interview data will be analyzed and summarized through content analysis. |
Up to 6 months
|
|
Intention to use and continuous use of the system over time
Prazo: Up to 12 months
|
Qualitative data, including brief interview data will be analyzed and summarized through content analysis. |
Up to 12 months
|
|
Self-reported patient engagement
Prazo: Up to 6 months
|
Self-reported patient engagement will be measured by the 9-item Twente Engagement with Ehealth Technologies Scale (TWEETS), including three dimensions, behavioral engagement, cognitive engagement, and affective engagement. Will use the overall TWEETS score to evaluate patient engagement in this study, rather than analyzing each dimension separately. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. Will use repeated measures analysis of variance to assess the changes in mean scores of patient engagement. Univariate associations between baseline personal and clinical factors and patient engagement at each time point will be assessed using correlation analyses (Pearson or Spearman), Chi-square tests, or non-parametric Mann-Whitney U tests, depending on the variable types. Multiple linear regressions will be conducted to assess associations between patient engagement and outcomes. |
Up to 6 months
|
|
System usage over time
Prazo: Up to 12 months
|
Will be objectively recorded by the system logs and analyzed using Google Analytics (dashboard only), including parameters like the number of logins, number of tab pages clicked, number of events or concerns self-tracked, and more. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. |
Up to 12 months
|
|
Patient activation levels
Prazo: Up to 6 months
|
Patient activation levels will be measured by the Short Form of Patient Activation Measure. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. |
Up to 6 months
|
|
Medication self-management ability
Prazo: Up to 6 months
|
Medication self-management ability will be measured by the Measure of Medication Self-Management. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. |
Up to 6 months
|
|
Symptom distress
Prazo: Up to 6 months
|
Symptom distress will be measured by the 19-item MD Anderson Symptom Inventory. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. |
Up to 6 months
|
|
Health related quality of life
Prazo: Up to 6 months
|
Health-related quality of life will be measured by the 27-item Functional Assessment of Cancer Therapy - General. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. |
Up to 6 months
|
|
Number of emergency room visits
Prazo: Up to 12 months
|
Will be measured by both self-report and chart review. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. |
Up to 12 months
|
|
Number of hospitalizations
Prazo: Up to 12 months
|
Will be measured by both self-report and chart review. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. |
Up to 12 months
|
|
User experiences with the system
Prazo: Up to 6 months
|
Participants' user experiences with the system, such as perceived facilitators or barrios to system use, along with their suggestions for system improvement, will be collected through a brief individual interview. Qualitative data, including brief interview data will be analyzed and summarized through content analysis. |
Up to 6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Self-tracked, structured medication safety events or concerns
Prazo: Up to 12 months
|
To understand the nature and causes of events and concerns, self-tracked, structured medication safety events or concerns tracking data from the system, such as the number and types of events or concerns self-tracked, will be summarized using descriptive statistics. The free-text tracking data from the system will be analyzed and summarized through content analysis or natural language processing techniques, depending on data volume. |
Up to 12 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Yun Jiang, University of Michigan Rogel Cancer Center
- Investigador principal: Yang Gong, UTHealth Houston McWilliam School of Biomedical Informatics
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
- Doenças urogenitais
- Doenças Genitais
- Neoplasias Genitais Masculinas
- Neoplasias urogenitais
- Neoplasias por local
- Neoplasias
- Doenças Genitais, Masculino
- Doenças prostáticas
- Doenças Urogenitais Masculinas
- Doenças Intestinais
- Doenças Respiratórias
- Neoplasias gastrointestinais
- Neoplasias do Aparelho Digestivo
- Doenças do aparelho digestivo
- Doenças Gastrointestinais
- Neoplasias Intestinais
- Doenças retais
- Doenças pulmonares
- Neoplasias do Trato Respiratório
- Neoplasias Torácicas
- Doenças do cólon
- Doenças de pele
- Doenças da mama
- Doenças da Pele e do Tecido Conjuntivo
- Neoplasias prostáticas
- Neoplasias Pulmonares
- Neoplasias Colorretais
- Neoplasias da Mama
- Qualidade, acesso e avaliação da assistência médica
- Técnicas de investigação
- Métodos epidemiológicos
- Coleta de dados
- Mecanismos de avaliação de saúde
- Qualidade de assistência médica
- Saúde pública
- Meio ambiente e saúde pública
- Serviços de Saúde
- Instalações de saúde Força e serviços de trabalho
- Serviços de Saúde Infantil
- Serviços de Saúde Comunitária
- Serviços de Saúde Preventiva
- Fatores socioeconômicos
- Características da população
- Técnicas imunológicas
- Técnicas genéticas
- Estudos epidemiológicos
- Características do estudo epidemiológico
- Imunoprecipitação da cromatina
- Sequenciamento de nucleotídeos de alto rendimento
- Análise de sequência
- Análise de sequência, DNA
- Imunoprecipitação
- Estudos de coorte
- Métodos
- Entrevistas como tópico
- Intervenção precoce, educacional
- Status educacional
- Sequenciamento de imunoprecipitação de cromatina
- Estudos de acompanhamento
Outros números de identificação do estudo
- UMCC 2025.050
- NCI-2025-08754 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- HUM00272763 (Outro identificador: University of Michigan)
- R01HS027846 (Concessão/Contrato da AHRQ dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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