- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00554489
Physical Activity in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy
A Feasibility Study of a Physical Activity Intervention in Older Adult Inpatients With Acute Leukemia
RATIONALE: Physical activity sessions may help improve physical function, quality of life, and symptoms caused by chemotherapy in older patients with acute myelogenous leukemia.
PURPOSE: This clinical trial is studying how well physical activity works in improving quality of life in older patients with acute myelogenous leukemia undergoing chemotherapy.
Descripción general del estudio
Descripción detallada
OBJECTIVES:
Primary
- To test the feasibility of conducting a physical activity intervention in hospitalized older adults with acute myeloid leukemia (AML) undergoing induction or reinduction chemotherapy.
Secondary
- To obtain preliminary data regarding the effectiveness of a physical activity intervention on physical function, quality of life, and treatment-related symptoms in these patients.
OUTLINE: Patients undergo a baseline evaluation in week 1 focusing on basic demographics, health, physical function and quality-of-life assessments. These assessments include the Short Physical Performance Battery (SPPB); the Hand Grip Test of Muscular Strength; the Demographics and Physical Activity History; the Functional Assessment of Cancer Therapy (FACT-Leu); the Distress Thermometer; the Short-form Positive Affect Schedule (PANAS-SF); the Satisfaction with Life Scale (SWL); the FAST-23 Disability Measure; the Center for Epidemiologic Studies Depression Scale Short Form (CES-D); the Self-efficacy for Physical Activity Scale; the Intervention Feedback Form; and the Pre-Post Session Ratings. Some medical data may be obtained from the patient's medical record to assist in these assessments.
Beginning in weeks 2-5, patients undergo a 30-minute orientation to the exercise sessions that will be tailored to individual needs and abilities. Patients undergo a 30- to 45-minute group physical activity session twice a week, and a supervised individual session following the same format as the group session, once a week for 4 weeks. After completion of the physical activity intervention, patients complete an activities packet and repeat the physical function and quality of life assessments in weeks 5-6 and again upon readmission for consolidation therapy in weeks 9-13 .
After completion of study intervention, patients are followed for 4 months.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27157-1096
- Wake Forest University Comprehensive Cancer Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
- Histologically confirmed acute myeloid leukemia (AML) by WHO criteria
- Planning to undergo induction or reinduction chemotherapy
- Inpatient status at Wake Forest University Baptist Medical Center
- Must not require intensive care unit support
PATIENT CHARACTERISTICS:
- Able to understand English
- Medical eligibility confirmed with Leukemia Service Attending
- Ambulatory or able to walk with a cane
- No hemodynamic instability
- No acute thrombosis within the past 7 days
- No active ischemia within the past 7 days
- No uncontrolled pain
- Must have < 3 incorrect responses on the Pfeiffer Mental Status Exam
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
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)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Percentage of adults 50 years of age or older admitted for induction or reinduction chemotherapy for acute myeloid leukemia (AML) who are eligible for the study
Periodo de tiempo: day 1
|
day 1
|
|
Percentage of eligible patients recruited into the study
Periodo de tiempo: day 1
|
day 1
|
|
Number and frequency of reported barriers to eligibility and enrollment
Periodo de tiempo: day 1
|
day 1
|
|
Percentage of study participants who successfully completed the physical and the psychosocial measures
Periodo de tiempo: week 13
|
week 13
|
|
Record barriers to completion of the physical activity program
Periodo de tiempo: week 13
|
week 13
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Physical function as measured by the Short Physical Performance Battery (SPPB)
Periodo de tiempo: week 13
|
week 13
|
|
Quality of Life as measured with the Distress Thermometer
Periodo de tiempo: week 13
|
week 13
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Heidi D. Klepin, MD, Wake Forest University Health Sciences
- Investigador principal: Shannon Mihalko, PhD, Wake Forest University Health Sciences
- Silla de estudio: Suzanne C. Danhauer, PhD, Wake Forest University Health Sciences
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
Palabras clave
- leucemia mieloide aguda en adultos con anomalías 11q23 (MLL)
- leucemia mieloide aguda en adultos con inv(16)(p13;q22)
- leucemia mieloide aguda en adultos con t(15;17)(q22;q12)
- leucemia mieloide aguda en adultos con t(16;16)(p13;q22)
- leucemia mieloide aguda en adultos con t(8;21)(q22;q22)
- leucemia mieloide aguda recurrente en adultos
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CDR0000573938
- CCCWFU-98107
- IRB00003355
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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