A Pilot Study of Structured Palliative Care for Patients Enrolled on Phase I Clinical Trials
22 de abril de 2019 actualizado por: Case Comprehensive Cancer Center
The goal of this research study is to find out if providing patients who are enrolled in phase 1 clinical trials with structured supportive care will enable them to continue in the Phase 1 trial longer and improve their quality of life by reducing or treating side effects and by providing emotional and social support to the patient and family.
The structured supportive or palliative care intervention will be provided by a team of trained specialists which include doctors, nurses, social workers and spiritual care providers.
The supportive care team will provide treatment to address symptoms, such as pain or anxiety, caused by the cancer itself or from the treatment.
The team can make referrals to other specialists.
Such as psychologists or nutritionist, if needed, and can help arrange for services to address home care needs.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Primary Objective(s): To assess symptoms, adverse events, duration on study, reason for study discontinuation, and quality of life among patients participating in phase I clinical trials who receive structured palliative care, and those who receive standard supportive care. Duration on study will serve as the primary objective for sample size determination.
Secondary Objective(s):
1. To describe the quantity (e.g. hours), type, and cost of palliative care personnel services used by patients and caregivers receiving structured palliative care.
Exploratory:
- To compare adverse event profiles, duration on study, and quality of life between patients who receive structured palliative care and those receiving standard supportive care.
- To compare caregiver burden and quality of life between the study arms.
Tipo de estudio
Intervencionista
Inscripción (Actual)
132
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Ohio
-
Cleveland, Ohio, Estados Unidos, 44106
- Case Comprehensive Cancer Center
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Patient Inclusion Criteria:
- Patients must be enrolled in a Phase 1 clinical trial and be within 2 weeks of starting the experimental therapy or intervention.
- Patients are eligible to enroll on this study with or without the enrollment of their caregiver.
Patient Exclusion Criteria:
- Patients diagnosed with a hematologic malignancy.
Caregiver Inclusion Criteria:
- Any caregiver is considered eligible for this study; The caregiver is the person identified by the patient as the one who provides the most regular physical and/or emotional support.
- Caregivers must be willing to complete surveys at baseline and on monthly basis.
Caregiver Exclusion Criteria:
- Caregivers who are solely professional, paid caregivers
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Standard Supportive Care
|
Supportive care for the patient and caregiver will be provided by the treating oncologist.
|
|
Experimental: Structured Supportive Care
|
Supportive care for the patient and caregiver will be provided by the outpatient palliative care team which includes clinicians with specialized palliative care training, social workers, spiritual care specialists and mental health clinical nurse specialist.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Average total MSAS score
Periodo de tiempo: Up to 6 months
|
Assessment of patient burden
|
Up to 6 months
|
|
Average total FACT-G score
Periodo de tiempo: Up to 6 months
|
Measure patient quality of life
|
Up to 6 months
|
|
Reason for study discontinuation (Patient reported outcome)
Periodo de tiempo: Up to 6 months
|
Measure of central tendency for why patients discontinued the phase I study.
Patient reported outcomes for reason for study discontinuation will be qualitatively assessed
|
Up to 6 months
|
|
Duration on Study
Periodo de tiempo: Up to 6 months
|
Measure of central tendency of the duration patients were on the phase I study.
Duration on study will serve as the primary objective for sample size determination
|
Up to 6 months
|
|
Adverse events
Periodo de tiempo: Up to 6 months
|
Measure of central tendency of adverse events.
AE will be described and further categorized as modifiable (primary symptom experience) and non-modifiable (laboratory abnormalities).
The influence of adverse events on study outcomes particularly duration on study and reason for study discontinuation will be assessed.
An exploratory weighted adverse event score will be calculated using the equation: adverse event score = ∑ (NAE * GAE) where N denotes the adverse event number, G denotes grade, AE denotes adverse event.
These scores will be compared between study arms
|
Up to 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean number of hours of palliative care services
Periodo de tiempo: Up to 6 months
|
Mean number of hours utilized by patients and caregivers who received structured palliative care.
This analysis will be descriptive, reporting measures of central tendency
|
Up to 6 months
|
|
Type of palliative care services
Periodo de tiempo: Up to 6 months
|
Measure of central tendency for the type of palliative care services utilized by patients and caregivers who received structured palliative care.
This analysis will be descriptive, reporting measures of central tendency
|
Up to 6 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Frequency of adverse events of patients receiving structured and usual supportive care
Periodo de tiempo: Up to 6 months
|
Up to 6 months
|
|
|
Average days on study
Periodo de tiempo: Up to 6 months
|
Up to 6 months
|
|
|
Change in FACT-G score
Periodo de tiempo: From baseline to last contact, up to 6 months
|
Change in patient symptom burden when compared to baseline between patients who received structured palliative care and those who received standard supportive care
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From baseline to last contact, up to 6 months
|
|
Change in MSAS score
Periodo de tiempo: From baseline to last contact, up to 6 months
|
Change in quality of life when compared to baseline between patients who received structured palliative care and those who received standard supportive care
|
From baseline to last contact, up to 6 months
|
|
Change in CRA score
Periodo de tiempo: From baseline to last contact, up to 6 months
|
Change in caregiver burden when compared to baseline between those who received structured palliative care and those who received standard supportive care
|
From baseline to last contact, up to 6 months
|
|
Change in QOLLTI-F score
Periodo de tiempo: From baseline to last contact, up to 6 months
|
Change in caregiver quality of life as assessed through change in QOLLTI-F score when compared to baseline between those who received structured palliative care and those who received standard supportive care
|
From baseline to last contact, up to 6 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Michelle Treasure, MD, Metrohealth Medical Center and Case Comprehensive Cancer Center
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
25 de octubre de 2015
Finalización primaria (Actual)
10 de enero de 2019
Finalización del estudio (Actual)
10 de enero de 2019
Fechas de registro del estudio
Enviado por primera vez
4 de septiembre de 2015
Primero enviado que cumplió con los criterios de control de calidad
4 de septiembre de 2015
Publicado por primera vez (Estimar)
7 de septiembre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de abril de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
22 de abril de 2019
Última verificación
1 de abril de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- CASE5Y15
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