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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Saint-Herblain, Francie, 44800
- Nábor
- Institut de Cancérologie de l'Ouest
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Kontakt:
- BOIFFARD Florence, MD
- Telefonní číslo: +33240679900
- E-mail: florence.boiffard@ico.unicancer.fr
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Effect of an APA program on cognitive functions (inhibition)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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To determine if the APA program modifies PA (Physical Activity) patterns in daily life
Časové okno: 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
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 8 weeks
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Fatigue level: Multidimensional Fatigue Inventor (MFI)
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8 weeks
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: BOIFFARD Florence, MD, Institut de Cancérologie de l'Ouest
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- ICO-N-2018-21
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