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Cancer Related Cognitive Impairment (APACO)

13 mei 2019 bijgewerkt door: Institut Cancerologie de l'Ouest

Physical Activity, Cancer and Cognitive Function Disorders : Effects of an Adapted Physical Activity Program on Impaired Cognitive Function in the Management of Cancer

Various recent scientific data testify to the cognitive deficiencies of cancer patients, called Cancer-Related Cognitive Impairments (CRCI) (Noal, Daireaux & Joly, 2010). At the same time, regular physical activity (aerobic, muscle building, and yoga) has been shown to decrease CRCIs, although commonly used cognitive measures are self-reported (Zimmer et al., 2016). The investigators will develop an interventional study using objective measures of cognition to confirm the cause-and-effect relationship, and specify the orientation of the cognitive effects of the adapted physical activities. The main and original objective will be to determine if the cognitive functions most affected by CRCI (episodic memory, inhibition, treatment speed) can be optimized in patients undergoing treatment.

Studie Overzicht

Toestand

Onbekend

Gedetailleerde beschrijving

  1. 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.

  2. 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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

26

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Male or female> or = 18 years old
  2. Any patient being treated for a cancerous condition and managed by adjuvant chemotherapy.
  3. Any type of cancer
  4. Beneficiary of a social protection scheme
  5. Having as mother tongue the French language
  6. Patient information and obtaining express consent

Exclusion Criteria:

  1. Protected subjects known as vulnerable (major under legal protection, adults unable to express their consent, subject admitted to a health and social institution).
  2. Minor subjects
  3. Pregnant women, likely to be pregnant or breastfeeding
  4. Subjects with sensory disabilities affecting vision or hearing
  5. Neurological or psychiatric antecedents
  6. Persons deprived of liberty or guardianship (including trusteeship).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Effect of an APA program on cognitive functions (inhibition)
Tijdsspanne: 8 weeks
For inhibition, effect of APA program on cognitive functions is evaluated with Stroop task.
8 weeks
Effect of an APA program on cognitive functions (speed function of information processing)
Tijdsspanne: 8 weeks
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.
8 weeks
Effect of an APA program on cognitive functions (Episodic Memory Function)
Tijdsspanne: 8 weeks
For Episodic Memory Function, effect of APA program on cognitive functions is evaluated with MEM III test.
8 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
To determine if the APA program modifies PA (Physical Activity) patterns in daily life
Tijdsspanne: 8 weeks
Evaluated with Global Physical Activity Questionnaire
8 weeks
To determine if the APA program modifies PA (Physical Activity) patterns in daily life
Tijdsspanne: 8 weeks
Evaluated with Actimeter
8 weeks
Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors.
Tijdsspanne: 8 weeks
Level of overall cognitive abilities: Montreal Cognitive Assessment (MOCA)
8 weeks
Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors.
Tijdsspanne: 8 weeks
Level of education: questionnaire measuring the number of years of study
8 weeks
Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors.
Tijdsspanne: 8 weeks
Level of Anxiety and Depression: Hospital and Anxiety Depression Scale (HADS).
8 weeks
Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors.
Tijdsspanne: 8 weeks
Fatigue level: Multidimensional Fatigue Inventor (MFI)
8 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: BOIFFARD Florence, MD, Institut de Cancérologie de l'Ouest

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

28 februari 2019

Primaire voltooiing (Verwacht)

1 juni 2019

Studie voltooiing (Verwacht)

1 september 2019

Studieregistratiedata

Eerst ingediend

7 mei 2019

Eerst ingediend dat voldeed aan de QC-criteria

13 mei 2019

Eerst geplaatst (Werkelijk)

14 mei 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 mei 2019

Laatste update ingediend die voldeed aan QC-criteria

13 mei 2019

Laatst geverifieerd

1 mei 2019

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • ICO-N-2018-21

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Adapted Physical Activity Program

3
Abonneren