- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00416481
Assessing Older Patients With Cancer
Development of a Geriatric Assessment Measure for Older Patients With Cancer
RATIONALE: Questionnaires that measure the ability of older patients to think, learn, remember, and make judgments and carry out daily activities may improve the ability to plan treatment for patients with cancer.
PURPOSE: This clinical trial is studying ways to assess older patients with cancer.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- Determine the feasibility of administration of the geriatric assessment in elderly patients with cancer.
- Determine the percentage of patients able to complete the self-administered portion of the geriatric assessment without assistance.
- Determine the length of time necessary to complete the geriatric assessment.
- Determine the variance and number of missing items.
- Assess patient satisfaction with the questionnaire by identifying items that are distressing or difficult to comprehend.
- Assess the percentage of geriatric assessments that contain all three of the following items: Timed Up and Go Assessment, Blessed Orientation-Memory-Concentration Test, and healthcare professional-rated Karnofsky performance status.
Secondary
- Determine the proportion of patients who are able to complete the self-report portion of the questionnaire without assistance and the length of time needed to complete the geriatric assessment within patients of various sociodemographic factors and educational status.
OUTLINE: This is a multicenter study. Patients are stratified according to age (65 to 69 years vs 70 years and over).
Patients undergo assessments of cognition using the Blessed Orientation-Memory-Concentration Test; functional status using the Timed Up and Go Assessment (measures physical mobility); and performance status using the healthcare professional-rated Karnofsky performance scale. These assessments are performed by healthcare personnel. Body mass index and the percentage of unintentional weight loss and the number of falls in the past 6 months are also assessed.
Patients also complete the following self-administered questionnaires: Instrumental Activities of Daily Living (measures level of functioning and need for services); Activities of Daily Living (measures higher levels of physical functioning); Karnofsky Self-Reported Performance Rating Scale (related to survival and clinically significant illness); Physical Health Section of the Older American Resources and Services Questionnaire (measures comorbidity and the impact on daily activities); Hospital Anxiety and Depression Scale; Medical Outcomes Study (MOS) Social Activity Limitations Measure (measures the impact of cancer on patients' social functioning); and MOS Social Support Survey Emotional/Information and Tangible Subscales (measures perceived availability of social support).
Patients then begin planned treatment.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Indiana
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Elkhart, Indiana, Estados Unidos, 46515
- Elkhart General Hospital
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Kokomo, Indiana, Estados Unidos, 46904
- Howard Community Hospital
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La Porte, Indiana, Estados Unidos, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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South Bend, Indiana, Estados Unidos, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Estados Unidos, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, Estados Unidos, 46617
- Saint Joseph Regional Medical Center
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South Bend, Indiana, Estados Unidos, 46601
- Michiana Hematology-Oncology, PC - South Bend
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Michigan
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St. Joseph, Michigan, Estados Unidos, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89102
- University Medical Center of Southern Nevada
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Las Vegas, Nevada, Estados Unidos, 89106
- CCOP - Nevada Cancer Research Foundation
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New York
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East Syracuse, New York, Estados Unidos, 13057
- CCOP - Hematology-Oncology Associates of Central New York
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke Comprehensive Cancer Center
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Ohio
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Columbus, Ohio, Estados Unidos, 43210-1240
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at 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
Método de muestreo
Población de estudio
Descripción
DISEASE CHARACTERISTICS:
- Histologically confirmed malignancy at any stage
- Enrolled on any cooperative group-sponsored cancer treatment trial (treatment has not yet started), including trials on the Cancer Trials Support Unit
PATIENT CHARACTERISTICS:
- Any performance status allowed
- Must be able to follow directions in English
- Sufficient cognitive and psychological function to give consent
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Patient assessment
Patients undergo assessments of cognition and performance status using the healthcare professional-rated Karnofsky performance scale. These assessments are performed by healthcare personnel. Body mass index and the percentage of unintentional weight loss and the number of falls in the past 6 months are also assessed. Patients also complete self-administered questionnaires that measure level of functioning and need for services. It also includes questionnaires that measure higher levels of physical functioning, performance related to survival and clinically significant illness and measures of comorbidity and the impact on daily activities. Lastly, questionnaires are administered to measure the impact of cancer on patients' social functioning and perceived availability of social support. Patients then begin planned treatment. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Mean and median time to complete the entire geriatric assessment
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
Mean number of missing items in each subscale and the distribution of missing items
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
Percentage of patients who identify a scale to be upsetting or difficult to understand
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
Percentage of Geriatric Assessments for which all three items (Timed Up and Go Assessment, Blessed Orientation-Memory-Concentration Test, and the healthcare professional-rated Karnofsky performance status) are completed
Periodo de tiempo: Up to 3 years
|
Up to 3 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Alice B. Kornblith, PhD, Dana-Farber Cancer Institute
Publicaciones y enlaces útiles
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- CALGB-360401
- CDR0000523527 (Identificador de registro: NCI Physician Data Query)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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