Programa eletrônico de monitoramento de sintomas para encaminhamentos paliativos desencadeados em pacientes com câncer torácico
SyMPLER: encaminhamentos paliativos acionados por pacientes e cuidadores por meio de um programa eletrônico de monitoramento de sintomas
This clinical trial evaluates earlier symptom management through remote electronic symptom monitoring (such as through an app on patient's phone), and accessibility of palliative care self-referral by patients with thoracic cancer and caregivers by proxy (legal representative). Thoracic cancer occurs in the chest and often causes symptoms for patients. Patients and/or their caregivers are often unable to attend in-person clinic visits for various reasons. The most frequently reported symptom by patients at initial palliative care consultations is pain, and caregivers' most common concerns are pain management for the patient, stress reduction, and fears about patient decline. Earlier palliative care referral can help control these symptoms before they worsen, providing a better quality of life for patients and caregivers. improve physical and emotional functioning for patients and caregivers in cancer care. This study may help researchers learn how an electronic symptom monitoring program may provide an earlier and more accessible way for patients with thoracic cancer to receive palliative care.
Visão geral do estudo
Status
Condições
Descrição detalhada
PRIMARY OBJECTIVE:
I. Develop and assess feasibility of a remote electronic symptom monitoring program with a prompted option for palliative care self-referral for patients or caregivers by proxy after diagnosis of a thoracic malignancy.
SECONDARY OBJECTIVE:
I. Evaluate palliative care referral patterns after implementation of a remote electronic symptom monitoring program.
OUTLINE:
Patients and their caregivers use the electronic symptom monitoring program to log symptoms once a week (QW) for 24 weeks. Patients and their caregivers also watch a video and review education materials prior to starting the remote symptom monitoring program.
After completion of study intervention, participants are followed up to 2 years.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Ohio
-
Columbus, Ohio, Estados Unidos, 43210
- Ohio State University Comprehensive Cancer Center
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- PATIENTS: Age ≥ 18 years
- PATIENTS: Diagnosed with any stage (1-4) or type (non-small cell lung cancer, small cell lung cancer, mesothelioma, thymic carcinoma) of thoracic malignancy
- PATIENTS: ≥ 2 visits at the Ohio State University Comprehensive Cancer Center (OSUCCC) Thoracic Oncology Clinic
- PATIENTS: Study enrollment within 12 weeks of initial Thoracic Medical Oncology appointment
- PATIENTS: Ability to understand and willingness to sign an informed consent document (or indicate approval or disapproval by another means)
- PATIENTS: Ability to read and understand English
- PATIENTS: Access to a device with email or text messaging capability
- CAREGIVERS: Age ≥ 18 years
- CAREGIVERS: Identified by patient participant as primary caregiver
- CAREGIVERS: Corresponding patient participant has consented to participate in the study
- CAREGIVERS: Ability to understand and willingness to sign an informed consent document (or indicate approval or disapproval by another means)
- CAREGIVERS: Ability to read and understand English
- CAREGIVERS: Access to a device with email or text messaging capability
Exclusion Criteria:
- PATIENTS: Patients who have been previously referred to ambulatory palliative care are excluded from participation
- PATIENTS: Prisoners are excluded from participation
- PATIENTS: Pregnant patients are excluded from participation
- PATIENTS: Patients who lack capacity for medical decision-making as determined by their primary oncologist are excluded from participation
- PATIENTS: There is NO exclusion criteria pertaining to Eastern Cooperative Oncology Group (ECOG) performance status, laboratory values, prior cancer diagnoses, presence of comorbidities or brain metastases
Plano de estudo
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: Supportive Care (electronic symptom monitoring program)
Patients and their caregivers participate use the electronic symptom monitoring program to log symptoms QW for 24 weeks. Patients and their caregivers also watch a video and review education materials prior to starting the remote symptom monitoring program. |
Ancillary studies Review education materials Ancillary studies Participate use the electronic symptom monitoring program to log symptoms Watch a video |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Frequency of symptom logging
Prazo: At 6 months after enrollment
|
Will estimate that ≥ 50% of patient participants will log symptoms at least monthly through the remote electronic symptom monitoring program. |
At 6 months after enrollment
|
|
Proportion of patients enrolled (Feasibility)
Prazo: At enrollment and 3 months
|
Descriptive statistics will include study enrollment rates (eligible vs. ineligible participants, consented vs. refused), completion rate of weekly symptom monitoring (patient vs. caregiver by proxy), and person requesting palliative care services (patient vs. caregiver by proxy vs. medical provider), if applicable. Will be considered feasible if within 20% of target enrollment. |
At enrollment and 3 months
|
|
Symptom scores and Palliative Referral Association
Prazo: At enrollment and 3 months and 6 months
|
Symptom scores (Edmonton Symptom Assessment Scale revised with Constipation and Sleep [ESAS-r-CS]) reported by patients and caregivers will be tracked and their association with palliative care referral, if applicable, will be assessed. |
At enrollment and 3 months and 6 months
|
|
Patient and Caregiver Symptom Reporting Congruency
Prazo: At enrollment and 3 months and 6 months
|
Descriptive statistics will be used to assess for congruency between patient and proxy-reported symptom assessments. Patients' oncologic treatment (chemotherapy, immunotherapy, radiation therapy, surgery) will be abstracted from the electronic medical record (EMR) at the time of each ESAS-r-CS survey completed by either the patient or caregiver by proxy. |
At enrollment and 3 months and 6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Palliative care referral patterns
Prazo: Up to 24 months
|
Palliative care referrals pre- and post- launch of the SyMPLER study will be evaluated for trends. Historical control data collecting palliative referrals by month will be compared between groups (pre-post- launch). |
Up to 24 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Julia L Agne, MD, Ohio State University Comprehensive Cancer Center
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (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
Outros números de identificação do estudo
- OSU-23149
- NCI-2024-00269 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .