Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy
Feasibility Study of a Cognitive Assessment Tool During Systemic Chemotherapy for Cancer Patients
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
PRIMARY OBJECTIVES:
I. To assess the feasibility of administering a cognitive assessment battery in a medical oncology clinic.
SECONDARY OBJECTIVES:
I. To estimate the variability of the various cognitive tests and to assess changes in cognitive performance based on the results of cognitive assessments obtained prior to chemotherapy and at 6 to 8 weeks and 12 to 16 weeks after the initiation of chemotherapy.
II. To explore the association of cognitive performance with the Eastern Cooperative Oncology Group (ECOG) performance status as evaluated by the patient's oncology team.
III. To assess the association between cognitive performance and the occurrence of a serious adverse event during chemotherapy.
OUTLINE:
Patients complete cognitive assessments, comprising Hopkins Verbal Learning Test-Revised (HVLT-R), Trail Making Test Parts A & B (TMT-A, TMT-B), Digit Symbol Coding Test (DSC), Category Fluency Test (Animals), Montreal Cognitive Assessment (MoCA), and Digit Span Test (DST). Patients also complete the Beck Depression Inventory. Assessments are administered on day 1 of chemotherapy and at 6-8 weeks and 12-16 weeks after day 1 of chemotherapy.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27157
- Wake Forest University Health Sciences
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed cancer
- Patients are candidates for systemic chemotherapy for their cancer diagnosis
- Life expectancy must be greater than 6 months
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients who have had prior systemic chemotherapy in their lifetime
- Patients with known brain metastases should be excluded from this clinical trial because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- Patients may not be participating on any other study investigating cognitive function
- Patients who are non-English speaking are ineligible
- Patients with hematologic malignancies are ineligible
- Patients with primary central nervous system malignancies are ineligible
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Supportive Care (cognitive assessment)
Patients complete cognitive assessments, comprising HVLT-R, TMT-A, TMT-B, DSC, Animals, MoCA, and DST.
Patients also complete the Beck Depression Inventory.
Assessments are administered on day 1 of chemotherapy and at 6-8 weeks and 12-16 weeks after day 1 of chemotherapy.
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Estudios complementarios
Otros nombres:
Given cognitive assessments
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Operational and logistical feasibility of administering cognitive assessment battery in medical oncology clinic environment during administration of chemotherapy.
Periodo de tiempo: Baseline to 16 weeks after the start of chemotherapy
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To determine whether cognitive assessment tools can be administered within the clinical and scheduling constraints of current chemotherapy administration practices.
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Baseline to 16 weeks after the start of chemotherapy
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in cognition over time
Periodo de tiempo: Baseline to 16 weeks after the start of chemotherapy
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As measured by cognitive assessment instruments
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Baseline to 16 weeks after the start of chemotherapy
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Association of cognitive performance with performance status and adverse events (AE)
Periodo de tiempo: Baseline to 16 weeks after the start of chemotherapy
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Baseline to 16 weeks after the start of chemotherapy
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Heidi Klepin, MD, Wake Forest University Health Sciences
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 (Estimar)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB00018421
- NCI-2011-03034 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- CCCWFU 99611 (Otro identificador: Wake Forest University Health Sciences)
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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