Cancer Related Cognitive Impairment (APACO)
Physical Activity, Cancer and Cognitive Function Disorders : Effects of an Adapted Physical Activity Program on Impaired Cognitive Function in the Management of Cancer
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Inclusion procedure and saving selection failures Participation in this study will be offered to patients during their care in day hospital (= inclusion visit).
Any patient giving express consent to participation and meeting the criteria for inclusion and non-inclusion will then be included in the study.
Each patient will then be identified by his or her initials as a patient number in the study, directly on the basis of collecting the data from the study.
- Study progress for patients Data collection takes place over two different periods. Each period lasts 12 weeks. The Adapted Physical Activity (APA) program is 8 weeks old.
The first period will run from mid-January to early April (first cohort) to collect data from the first patients in the experimental group.
The second period will be from mid-February to the end of April. During this one, it will be necessary to collect the data of the last patients of the experimental group (second cohort) The first two weeks of each period (weeks 1 and 2, weeks 4 and 5) are dedicated to recruiting patients.
During the pre-test session, carried out week 3 for the first cohort and weeks 6 for the second, the patients will carry out different tests and questionnaires: General Information Questionnaires, Education, MoCA (Montreal Cognitive Assessment), GPAQ (Global Physical Activity Questionnaire), Stroop test, test of MEM3 (Echelle Clinique de Mémoire), letter comparison test, HADS (Hospital and Anxiety Depression Scale), and the MFI (Multidimensional Fatigue Inventory). Patients should also wear an actimeter for one week from the day of recruitment.
Patients then take part in a program of Adapted Physical Activity lasting 8 weeks, with 2 sessions per week. The sessions of this program are similar to the APA sessions already offered by sports therapy practitioners. This is an aerobic exercise session, with Nordic walking, and a combined session of muscle building and breathing-based exercises.
In the post-test session, which was conducted week 12 for the first cohort and week 15 for the second, some questionnaires and tests are again administered: GPAQ, Stroop test, MEM3 test, letter comparison test, HADS and the MFI. Patients should also wear an actimeter the week before the day of the post-test.
The forecast schedule may be slightly modified depending on unforeseen circumstances and constraints that may occur.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Saint-Herblain, Francia, 44800
- Reclutamiento
- Institut de Cancérologie de l'Ouest
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Contacto:
- BOIFFARD Florence, MD
- Número de teléfono: +33240679900
- Correo electrónico: florence.boiffard@ico.unicancer.fr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Male or female> or = 18 years old
- Any patient being treated for a cancerous condition and managed by adjuvant chemotherapy.
- Any type of cancer
- Beneficiary of a social protection scheme
- Having as mother tongue the French language
- Patient information and obtaining express consent
Exclusion Criteria:
- Protected subjects known as vulnerable (major under legal protection, adults unable to express their consent, subject admitted to a health and social institution).
- Minor subjects
- Pregnant women, likely to be pregnant or breastfeeding
- Subjects with sensory disabilities affecting vision or hearing
- Neurological or psychiatric antecedents
- Persons deprived of liberty or guardianship (including trusteeship).
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)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Adapted Physical Activity Program
Patients in the experimental group take part in a program of Adapted Physical Activity lasting 6 weeks, with 2 sessions per week.
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The sessions in this program are similar to the adapted physical activity sessions already offered by sports therapy practitioners.
This is an aerobic exercise session, with Nordic walking, and a combined session of muscle building and breathing exercises.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Effect of an APA program on cognitive functions (inhibition)
Periodo de tiempo: 8 weeks
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For inhibition, effect of APA program on cognitive functions is evaluated with Stroop task.
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8 weeks
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Effect of an APA program on cognitive functions (speed function of information processing)
Periodo de tiempo: 8 weeks
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For speed function of information processing, effect of APA program on cognitive functions is evaluated with XO letters comparison test.
During the XO letters comparison test, the participants will have to check the maximum number of identical or different boxes according to the combination of the two letters presented (XO, OX, XX or OO) in 30 seconds.
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8 weeks
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Effect of an APA program on cognitive functions (Episodic Memory Function)
Periodo de tiempo: 8 weeks
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For Episodic Memory Function, effect of APA program on cognitive functions is evaluated with MEM III test.
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8 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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To determine if the APA program modifies PA (Physical Activity) patterns in daily life
Periodo de tiempo: 8 weeks
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Evaluated with Global Physical Activity Questionnaire
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8 weeks
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To determine if the APA program modifies PA (Physical Activity) patterns in daily life
Periodo de tiempo: 8 weeks
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Evaluated with Actimeter
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8 weeks
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Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors.
Periodo de tiempo: 8 weeks
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Level of overall cognitive abilities: Montreal Cognitive Assessment (MOCA)
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8 weeks
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Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors.
Periodo de tiempo: 8 weeks
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Level of education: questionnaire measuring the number of years of study
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8 weeks
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Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors.
Periodo de tiempo: 8 weeks
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Level of Anxiety and Depression: Hospital and Anxiety Depression Scale (HADS).
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8 weeks
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Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors.
Periodo de tiempo: 8 weeks
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Fatigue level: Multidimensional Fatigue Inventor (MFI)
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8 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: BOIFFARD Florence, MD, Institut de Cancérologie de l'Ouest
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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-N-2018-21
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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