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Cancer Related Cognitive Impairment (APACO)

13 maj 2019 uppdaterad 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.

Studieöversikt

Status

Okänd

Detaljerad beskrivning

  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.

Studietyp

Interventionell

Inskrivning (Förväntat)

26

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Samarbetspartners

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

28 februari 2019

Primärt slutförande (Förväntat)

1 juni 2019

Avslutad studie (Förväntat)

1 september 2019

Studieregistreringsdatum

Först inskickad

7 maj 2019

Först inskickad som uppfyllde QC-kriterierna

13 maj 2019

Första postat (Faktisk)

14 maj 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

14 maj 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 maj 2019

Senast verifierad

1 maj 2019

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • ICO-N-2018-21

Läkemedels- och apparatinformation, studiedokument

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Kliniska prövningar på Adapted Physical Activity Program

3
Prenumerera