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
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Zapisy (Oczekiwany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Saint-Herblain, Francja, 44800
- Rekrutacyjny
- Institut de Cancérologie de l'Ouest
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Kontakt:
- BOIFFARD Florence, MD
- Numer telefonu: +33240679900
- E-mail: florence.boiffard@ico.unicancer.fr
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Effect of an APA program on cognitive functions (inhibition)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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To determine if the APA program modifies PA (Physical Activity) patterns in daily life
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 8 weeks
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Fatigue level: Multidimensional Fatigue Inventor (MFI)
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8 weeks
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: BOIFFARD Florence, MD, Institut de Cancérologie de l'Ouest
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- ICO-N-2018-21
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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