- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04675814
Prospective Evaluation of the Impact on Patients' Quality of Life of a 12-Week Adapted Physical Activity Program (APA) (APA)
Prospective Evaluation of the Impact on Patients' Quality of Life of a 12-Week Adapted Physical Activity Program (APA) at Institut de Cancerologie de l'Ouest (ICO)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The objective of this study is to evaluate the effects of regular physical practice on fatigue, quality of life and kinesiophobia in patients treated at the ICO in Angers, regardless of the type of cancer and the type of treatment.
A 12-week Adapted Physical Activity program (APA) is proposed to patients included in the study with an assessment of fatigue, quality of life, level of physical activity and kinesiophobia (fear of movement) at the beginning of the study.
A second assessment of fatigue and quality of life will be done during the 6-week management.
At the end of the program, a final evaluation of fatigue, quality of life and kinesiophobia will be done.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Angers, Francia, 49055
- Institu de Cancérologie de L'Ouest
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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:
- Oncological care at the ICO
- All types of cancer
- Regardless of the type of treatment (chemotherapy, radiotherapy, hormone therapy, immunotherapy)
- Age > 18 years old
- Follow the APA program at the ICO
- Subject informed of the study
Exclusion Criteria:
- Contraindication to the practice of sport
- APA Program outside the ICO
- Subject opposing the use of his data
- Minor or adult patient under guardianship or curatorship
- Pregnant woman
- Altered general condition
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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quality of life of patients participating in the 12-week adapted physical activity program.
Periodo de tiempo: 12 weeks
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Describe the evolution of the quality of life of patients being treated for their cancer pathology at the ICO site in Angers, and participating in the 12-week adapted physical activity program at the ICO. Quality of life is measured with the FACIT-F Fatigue and Quality of Life Questionnaire. This is a 13-question questionnaire in which the patient ranks on a Likert-type scale ranging from 1 to 5 (1 = completely, 5 = not at all). By adding up the answers, a score out of 65 is obtained: the higher the score, the less tired the patient is. |
12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Describe attendance at the APA program.
Periodo de tiempo: 12 weeks
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The number of sessions is planned by the APA coach at the beginning of the APA program.
The number of missing sessions will be measured.
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12 weeks
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Measure the evolution of Kinesiophobia (fear of movement).
Periodo de tiempo: 12 weeks
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Kinesiophobia is measured with the TAMPA questionnaire.
This tool assesses the kinesiophobia index presented by the patient at the time of the assessment.
The higher the score, the greater the level of kinesiophobia.
A score of 40/68 is considered significant kinesiophobia.
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12 weeks
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Measure physical activity at the initiation of the APA program.
Periodo de tiempo: 12 weeks
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The level of physical activity is evaluated by the GPAQ questionnaire.
This questionnaire will assess the level of physical activity in work activities, modes of travel and leisure activities.
It also evaluates sedentary behaviour.
It includes 16 questions.
The score obtained gives 3 profiles: insufficient activity level, level in line with recommendations and high level.
It also provides MET (metabolic equivalent) results corresponding to the subject's energy expenditure during physical activities.
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12 weeks
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Colaboradores e Investigadores
Patrocinador
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 (Actual)
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
Otros números de identificación del estudio
- ICO-2020-05
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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