Monitoramento de software de toxicidades relacionadas ao tratamento em carcinoma de células renais avançado
15 de abril de 2026 atualizado por: Chunkit Fung, University of Rochester
Monitoramento de toxicidades relacionadas ao tratamento de agentes orais direcionados e imunoterapia entre pacientes com carcinoma de células renais avançado (CCR) usando software Carevive, um estudo de viabilidade de fase II de braço único
Determinar se o software Carevive, que monitora as toxicidades relacionadas ao tratamento e, em seguida, gera planos de gerenciamento de autocuidado para esses sintomas, será viável para implementação entre pacientes com carcinoma de células renais metastático (CCR).
Além disso, para coleta de dados preliminares sobre toxicidades relacionadas ao tratamento, qualidade de vida, nível de sofrimento e adesão aos medicamentos.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
21
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
-
-
New York
-
Rochester, New York, Estados Unidos, 14642
- University of Rochester - Wilmot Cancer Institute
-
-
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 e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Descrição
Critério de inclusão:
- Diagnóstico de carcinoma de células renais confirmado histologicamente de qualquer subtipo com evidência patológica ou radiográfica de doença metastática
- Maior de 18 anos de idade
- Um oncologista participante do Wilmot Cancer Center determinou que o candidato deveria iniciar terapia oral direcionada ou imunoterapia para tratamento de seu CCR avançado; isso pode ser para terapia de primeira linha ou qualquer terapia de linha subsequente
- Capaz de fornecer consentimento informado por escrito
- Proficiente na língua inglesa e autorrelatado como alfabetizado
- Deve ter um endereço de e-mail ativo ou acesso a um dispositivo inteligente no qual mensagens de texto possam ser recebidas
Critério de exclusão:
- As mulheres não podem amamentar
- Não tem acesso regular à internet
- Incapaz de comparecer ao Wilmot Cancer Center para consultas a cada 3-4 meses para visitas de rotina com seu oncologista principal
- Os indivíduos que participaram do estudo anteriormente não poderão se inscrever novamente no caso de uma mudança de tratamento
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: Uso do software Carevive
Notificação e gerenciamento de efeitos colaterais de terapia oral direcionada ou imunoterapia, por meio do software Carevive, em pacientes com carcinoma de células renais (CCR) avançado.
|
Neste estudo, a Carevive fornecerá um link para os sujeitos para que uma pesquisa online possa ser concluída.
A pesquisa ocorrerá semanalmente durante as primeiras 12 semanas do estudo e será espaçada a cada duas semanas a partir de então.
As perguntas se concentrarão principalmente nos efeitos colaterais da terapia contra o câncer, bem como em algumas perguntas sobre conformidade com medicamentos e utilização de cuidados de saúde.
Após a conclusão da pesquisa, o sujeito receberá um plano de cuidados com opções de autogestão em casa para toxicidades relacionadas a medicamentos.
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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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Number of Participants Who Submitted at Least One Carevive Survey
Prazo: From enrollment through 48 weeks
|
Number of participants who completed at least one Carevive survey at any time during the 48 week study period.
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From enrollment through 48 weeks
|
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Percentage of Carevive Surveys Completed Per Participant
Prazo: From enrollment through 48 weeks
|
Percentage of Carevive surveys completed by each participant, calculated as the number of completed surveys divided by the number of surveys prompted by the Carevive software during the 48 week study period.
|
From enrollment through 48 weeks
|
|
Number of Participants Who Utilized at Least One Auto-Generated Carevive Care Plan
Prazo: From enrollment through 48 weeks
|
Number of participants who accessed at least one auto-generated Carevive care plan at any time during the 48 week study period.
|
From enrollment through 48 weeks
|
|
Percentage of Auto Generated Carevive Care Plans Utilized Per Participant
Prazo: From enrollment through 48 weeks
|
Percentage of auto generated Carevive care plans utilized by each participant, calculated as the number of care plans accessed divided by the total number of care plans generated for that participant during the 48 week study period.
|
From enrollment through 48 weeks
|
|
System Usability Scale (SUS) Score for Carevive Software
Prazo: From enrollment through 48 weeks
|
Participants completed the System Usability Scale (SUS), which is a validated 10-item questionnaire that produces a total usability score ranging from 0 to 100.
Scores are categorized into three main categories: excellent (>80.3 points); good (68.0 to 80.3 points) and below average (<68 points).
We calculated the SUS point for each participant who completed the survey.
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From enrollment through 48 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-DRS) Total Score
Prazo: From enrollment through 48 weeks
|
The FKSI-DRS is a validated patient-reported outcome measure assessing kidney cancer-related symptoms, with total scores ranging from 0 to 36, where higher scores indicate better quality of life.
|
From enrollment through 48 weeks
|
|
Distress Level Assessed by NCCN Distress Thermometer
Prazo: From enrollment through 48 weeks
|
The NCCN Distress Thermometer is a validated patient reported outcome measure assessing psychological distress on a scale from 0 to 10, with higher scores indicating greater distress.
Scores were categorized to reflect low distress (0-3) and moderate to severe distress (4-10).
|
From enrollment through 48 weeks
|
|
Health Care Utilization Assessment
Prazo: From enrollment through 48 weeks
|
Health care utilization was assessed based on participant self-report and defined as having at least one hospital visit, emergency room visit, or unplanned clinic visit during the 48-week study period.
|
From enrollment through 48 weeks
|
|
Participants Reporting Diarrhea
Prazo: From enrollment through 48 weeks
|
Number of participants who self reported Diarrhea (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting this symptom if they answered "Yes" to the corresponding survey question during the specified time period.
|
From enrollment through 48 weeks
|
|
Participants Reporting Nausea
Prazo: From enrollment through 48 weeks
|
Number of participants who self reported nausea (Yes or No) in response to PRO CTCAE survey questions assessing treatment related toxicities from oral targeted agents and immunotherapy.
Responses were collected using Carevive surveys administered weekly for the first 12 weeks and then every other week for an additional 36 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
|
From enrollment through 48 weeks
|
|
Participants Reporting Vomiting
Prazo: From enrollment through 48 weeks
|
Number of participants who self reported vomiting (Yes or No) in response to PRO CTCAE survey questions assessing treatment related toxicities from oral targeted agents and immunotherapy.
Responses were collected using Carevive surveys administered weekly for the first 12 weeks and then every other week for an additional 36 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
|
From enrollment through 48 weeks
|
|
Participants Reporting Fatigue
Prazo: From enrollment through 48 weeks
|
Number of participants who self reported fatigue (Yes or No) in response to PRO CTCAE survey questions assessing treatment related toxicities from oral targeted agents and immunotherapy.
Responses were collected using Carevive surveys administered weekly for the first 12 weeks and then every other week for an additional 36 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
|
From enrollment through 48 weeks
|
|
Participants Reporting Rash
Prazo: From enrollment through 48 weeks
|
Number of participants who self reported rash (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
|
From enrollment through 48 weeks
|
|
Participants Reporting Abdominal Pain
Prazo: From enrollment through 48 weeks
|
Number of participants who self reported abdominal pain (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
|
From enrollment through 48 weeks
|
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Participants Reporting Mouth Sores
Prazo: From enrollment through 48 weeks
|
Number of participants who self reported mouth sores (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
|
From enrollment through 48 weeks
|
|
Participants Reporting Cough
Prazo: From enrollment through 48 weeks
|
Number of participants who self reported cough (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
|
From enrollment through 48 weeks
|
|
Participants Reporting Shortness of Breath
Prazo: From enrollment through 48 weeks
|
Number of participants who self reported Shortness of Breath (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
|
From enrollment through 48 weeks
|
|
Participants Reporting Anorexia
Prazo: From enrollment through 48 weeks
|
Number of participants who self reported Anorexia (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting this symptom if they answered "Yes" to the corresponding survey question during the specified time period.
|
From enrollment through 48 weeks
|
|
Clinician Reported Diarrhea
Prazo: From enrollment through 48 weeks
|
Number of participants with clinician reported diarrhea assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Nausea
Prazo: From enrollment through 48 weeks
|
Number of participants with clinician reported nausea assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Vomiting
Prazo: From enrollment through 48 weeks
|
Number of participants with clinician reported vomiting assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Fatigue
Prazo: From enrollment through 48 weeks
|
Number of participants with clinician reported fatigue assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Rash
Prazo: From enrollment through 48 weeks
|
Number of participants with clinician reported Rash assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Abdominal Pain
Prazo: From enrollment through 48 weeks
|
Number of participants with clinician reported Abdominal Pain assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Mouth Sores
Prazo: From enrollment through 48 weeks
|
Number of participants with clinician reported Mouth Sores assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Cough
Prazo: From enrollment through 48 weeks
|
Number of participants with clinician reported Cough assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Shortness of Breath
Prazo: From enrollment through 48 weeks
|
Number of participants with clinician reported Shortness of Breath assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Anorexia
Prazo: From enrollment through 48 weeks
|
Number of participants with clinician reported Anorexia assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
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)
24 de julho de 2019
Conclusão Primária (Real)
14 de fevereiro de 2025
Conclusão do estudo (Real)
14 de fevereiro de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
18 de julho de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de julho de 2017
Primeira postagem (Real)
25 de julho de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
7 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de abril de 2026
Última verificação
1 de fevereiro de 2025
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Neoplasias urogenitais
- Neoplasias por local
- Neoplasias
- Doenças Urogenitais Masculinas
- Doenças renais
- Doenças Urológicas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Neoplasias por Tipo Histológico
- Neoplasias Glandulares e Epiteliais
- Adenocarcinoma
- Neoplasias Urológicas
- Neoplasias Renais
- Carcinoma
- Carcinoma de Células Renais
Outros números de identificação do estudo
- UGUK 17036
- UG1CA189961 (Concessão/Contrato do NIH dos EUA)
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
produto fabricado e exportado 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 .