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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02306252
The CARE Program: CAncer REhabilitation Pilot Study for Older Adults (CARE Program)
11 de septiembre de 2017 actualizado por: UNC Lineberger Comprehensive Cancer Center
LCCC 1409: The CARE Program: CAncer REhabilitation Pilot Study for Older Adults
The CARE Program is a randomized trial of a cancer rehabilitation program designed to help older cancer patients who have shown to have a loss of function.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a prospective, two-arm, single-center randomized controlled pilot trial of a cancer rehabilitation program for older adults, titled the 'CARE program,' which is designed to maintain and/or improve functional status and quality of life in older adults diagnosed with cancer.
Adults aged 65 years and older with cancer will be screened with a Geriatric Assessment (GA) for eligibility.
Although breast cancer patients will be eligible, this study will focus primarily on other types of cancers.
Adults with at least one functional deficit --defined as impairment in ability to perform activities of daily living or instrumental activities of daily living, cognitive decline or balance -- will be randomized to either the intervention (CARE program) or to the control arm (Supportive care services information only).
Both arms will receive a brochure about the supportive care program to provide patients who we've identified as having deficits with information about auxiliary services available and because the intent is to limit the difference between the groups.
We hypothesize that patients who participate in the CARE program will maintain or improve functional status and quality of life when compared to supportive care services information only.
Tipo de estudio
Intervencionista
Inscripción (Actual)
67
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
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- University of North Carolina
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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
65 años y mayores (Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Aged 65 years or older
- Has an outpatient appointment within UNC Chapel Hill Lineberger Comprehensive Cancer Center
- Diagnosis of cancer within last two years.
- Has a life expectancy of 12 months or longer. All cancer types are included.
- English speaking
- Willing to complete the UNC GA
- Has at least one functional deficit as defined by GA screen
- Understands study design, risks, and benefits and have signed informed consent
- Willing to be randomized into either study arm
- Ability to safely participate in outpatient rehabilitation program
Exclusion Criteria:
- Unable to safely participate in outpatient rehabilitation.
- Currently receiving rehabilitation.
- Any participant who has urologic cancer or is enrolled in a competing trial.
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 de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: CARE Intervention
This group will be contacted to make an appointment for outpatient Occupational and Physical therapy.
The therapist will determine the type, frequency and length of treatment.
Follow up phone calls will be made to ensure appointments are made, kept and rescheduled as needed.
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OT and PT will be arranged for the subject and conducted in a manner as determined by the therapist.
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Sin intervención: CARE Control
Patients randomized to this arm will receive contact information and a brochure outlining the services available within the supportive care program.
The study coordinator will provide the information based on their results and assist the patient with contacting the program if desired.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
To measure the change in Nottingham Extended Activities of Daily Living (NEADL) score from baseline to three months.
Periodo de tiempo: 3 months
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Compare the change in NEADL scores from baseline to 3 months between patients who receive the CARE program (intervention) and those in the control arm.
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3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
To measure the change in Activities of Daily Living from Baseline and 2 months
Periodo de tiempo: 2 months
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As measured by the Geriatric Assessment
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2 months
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To measure the change in Activities of Daily Living from Baseline and 3 months
Periodo de tiempo: 3 months
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As measured by the Geriatric Assessment
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3 months
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To measure the change in physical health from Baseline and 3 months
Periodo de tiempo: 3 months
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As measured by the Geriatric Assessment
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3 months
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To measure the change in physical health from Baseline and 2 months
Periodo de tiempo: 2 months
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As measured by the Geriatric Assessment
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2 months
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To measure the change in quality of life from Baseline and 2 months
Periodo de tiempo: 2 months
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As measured by the PROMIS assessment
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2 months
|
To measure the change in quality of life from Baseline and 3 months
Periodo de tiempo: 3 months
|
As measured by the PROMIS assessment
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3 months
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To measure the change in internalized occupational possibilities from Baseline and 3 months
Periodo de tiempo: 3 months
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As measured by the Possibilities for Activity Scale (PActS)
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3 months
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To measure the change in internalized occupational possibilities from Baseline and 2 months
Periodo de tiempo: 2 months
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As measured by the Possibilities for Activity Scale (PActS)
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2 months
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To measure the change in cognitive function from Baseline and 2 months
Periodo de tiempo: 2 months
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As measured by the Blessed Memory Orientation Concentration test
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2 months
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To measure the change in cognitive function from Baseline and 3 months
Periodo de tiempo: 3 months
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As measured by the Blessed Memory Orientation Concentration test
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3 months
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To measure the feasibility of the CARE Program
Periodo de tiempo: 3 months
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To describe the feasibility of the CARE program by reporting enrollment and retention as defined by (1) percent eligible who agree to participate (2) percent in each group that completed follow-up measures at 2 and 3 months and (3) percent of patients in CARE program who go to 70% of appointments.
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3 months
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To measure the change in balance over the course of the study
Periodo de tiempo: 3 months
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Intervention Group Only: As measured by the Berg Balance Scale
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3 months
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To measure the change in upper extremity use and ability over the course of the study
Periodo de tiempo: 3 months
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Intervention Group Only: As measured by the Disability of the Arm, Shoulder and Hand scale
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3 months
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To measure the change in cognition over the course of the study
Periodo de tiempo: 3 months
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Intervention Group Only: As measured by the Montreal Cognitive Assessment
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3 months
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To measure the change in dynamic gait ability over the course of the study
Periodo de tiempo: 3 months
|
Intervention Group Only: As measured by the Dynamic Gait Index
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3 months
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To measure satisfaction with the CARE Program
Periodo de tiempo: 3 months
|
To evaluate the program a short interview will be completed with CARE team to determine what worked well, what didn't and suggested changes/improvements for CARE program after completion of project.
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3 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Mackenzi Pergolotti, PhD, Colorado State University
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 (Actual)
1 de junio de 2014
Finalización primaria (Actual)
1 de marzo de 2017
Finalización del estudio (Actual)
1 de marzo de 2017
Fechas de registro del estudio
Enviado por primera vez
1 de diciembre de 2014
Primero enviado que cumplió con los criterios de control de calidad
2 de diciembre de 2014
Publicado por primera vez (Estimar)
3 de diciembre de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de septiembre de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
11 de septiembre de 2017
Última verificación
1 de septiembre de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- LCCC1409
- 14-1159 (Otro identificador: University of North Carolina IRB)
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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