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Cancer Related Cognitive Impairment (APACO)

13. mai 2019 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

  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

Intervensjonell

Registrering (Forventet)

26

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: Adapted Physical Activity Program
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Effect of an APA program on cognitive functions (inhibition)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 8 weeks
For Episodic Memory Function, effect of APA program on cognitive functions is evaluated with MEM III test.
8 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To determine if the APA program modifies PA (Physical Activity) patterns in daily life
Tidsramme: 8 weeks
Evaluated with Global Physical Activity Questionnaire
8 weeks
To determine if the APA program modifies PA (Physical Activity) patterns in daily life
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 8 weeks
Fatigue level: Multidimensional Fatigue Inventor (MFI)
8 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Institut Cancerologie de l'Ouest

Samarbeidspartnere

University of Poitiers

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. februar 2019

Primær fullføring (Forventet)

1. juni 2019

Studiet fullført (Forventet)

1. september 2019

Datoer for studieregistrering

Først innsendt

7. mai 2019

Først innsendt som oppfylte QC-kriteriene

13. mai 2019

Først lagt ut (Faktiske)

14. mai 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. mai 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. mai 2019

Sist bekreftet

1. mai 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • ICO-N-2018-21

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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