Programa electrónico de monitorización de síntomas para derivaciones paliativas activadas en pacientes con cáncer torácico
SyMPLER: Referencias paliativas activadas por pacientes y cuidadores a través de un programa electrónico de monitoreo de síntomas
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- Ohio State University Comprehensive Cancer Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Frequency of symptom logging
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Palliative care referral patterns
Periodo de tiempo: 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
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- OSU-23149
- NCI-2024-00269 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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