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出境医 / 临床实验 / Cancer Related Cognitive Impairment (APACO)

Cancer Related Cognitive Impairment (APACO)

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Patients Treated for Cancer Behavioral: Adapted Physical Activity Program Not Applicable

Detailed Description:

  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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Physical Activity, Cancer and Cognitive Function Disorders : Effects of an Adapted Physical Activity Program on Impaired Cognitive Function in the Management of Cancer
Actual Study Start Date : February 28, 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: 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.
 Behavioral: 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.
Outcome Measures
Primary Outcome Measures :
  1. Effect of an APA program on cognitive functions (inhibition) [ Time Frame: 8 weeks ]
    For inhibition, effect of APA program on cognitive functions is evaluated with Stroop task.

  2. Effect of an APA program on cognitive functions (speed function of information processing) [ Time Frame: 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.

  3. Effect of an APA program on cognitive functions (Episodic Memory Function) [ Time Frame: 8 weeks ]
    For Episodic Memory Function, effect of APA program on cognitive functions is evaluated with MEM III test.


Secondary Outcome Measures :
  1. To determine if the APA program modifies PA (Physical Activity) patterns in daily life [ Time Frame: 8 weeks ]
    Evaluated with Global Physical Activity Questionnaire

  2. To determine if the APA program modifies PA (Physical Activity) patterns in daily life [ Time Frame: 8 weeks ]
    Evaluated with Actimeter

  3. Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors. [ Time Frame: 8 weeks ]
    Level of overall cognitive abilities: Montreal Cognitive Assessment (MOCA)

  4. Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors. [ Time Frame: 8 weeks ]
    Level of education: questionnaire measuring the number of years of study

  5. Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors. [ Time Frame: 8 weeks ]
    Level of Anxiety and Depression: Hospital and Anxiety Depression Scale (HADS).

  6. Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors. [ Time Frame: 8 weeks ]
    Fatigue level: Multidimensional Fatigue Inventor (MFI)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations

Contacts
Layout table for location contacts
Contact: BOIFFARD Florence, MD +33240679900 florence.boiffard@ico.unicancer.fr
Contact: PACTEAU Valérie +33240679908 valerie.pacteau@ico.unicancer.fr

Locations
Layout table for location information
France
Institut de Cancérologie de l'Ouest Recruiting
Saint-Herblain, France, 44800
Contact: BOIFFARD Florence, MD    +33240679900    florence.boiffard@ico.unicancer.fr   
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
University of Poitiers
Investigators
Layout table for investigator information
Principal Investigator: BOIFFARD Florence, MD Institut de Cancérologie de l'Ouest
Tracking Information
First Submitted Date  ICMJE May 7, 2019
First Posted Date  ICMJE May 14, 2019
Last Update Posted Date May 14, 2019
Actual Study Start Date  ICMJE February 28, 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
  • Effect of an APA program on cognitive functions (inhibition) [ Time Frame: 8 weeks ]
    For inhibition, effect of APA program on cognitive functions is evaluated with Stroop task.
  • Effect of an APA program on cognitive functions (speed function of information processing) [ Time Frame: 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.
  • Effect of an APA program on cognitive functions (Episodic Memory Function) [ Time Frame: 8 weeks ]
    For Episodic Memory Function, effect of APA program on cognitive functions is evaluated with MEM III test.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
  • To determine if the APA program modifies PA (Physical Activity) patterns in daily life [ Time Frame: 8 weeks ]
    Evaluated with Global Physical Activity Questionnaire
  • To determine if the APA program modifies PA (Physical Activity) patterns in daily life [ Time Frame: 8 weeks ]
    Evaluated with Actimeter
  • Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors. [ Time Frame: 8 weeks ]
    Level of overall cognitive abilities: Montreal Cognitive Assessment (MOCA)
  • Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors. [ Time Frame: 8 weeks ]
    Level of education: questionnaire measuring the number of years of study
  • Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors. [ Time Frame: 8 weeks ]
    Level of Anxiety and Depression: Hospital and Anxiety Depression Scale (HADS).
  • Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors. [ Time Frame: 8 weeks ]
    Fatigue level: Multidimensional Fatigue Inventor (MFI)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cancer Related Cognitive Impairment
Official Title  ICMJE Physical Activity, Cancer and Cognitive Function Disorders : Effects of an Adapted Physical Activity Program on Impaired Cognitive Function in the Management of Cancer
Brief Summary 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.
Detailed Description

  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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Patients Treated for Cancer
Intervention  ICMJE Behavioral: 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.
Study Arms  ICMJE Experimental: 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.
Intervention: Behavioral: Adapted Physical Activity Program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 13, 2019) 		26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03949322
Other Study ID Numbers  ICMJE ICO-N-2018-21
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Cancerologie de l'Ouest
Study Sponsor  ICMJE Institut Cancerologie de l'Ouest
Collaborators  ICMJE University of Poitiers
Investigators  ICMJE
Principal Investigator: BOIFFARD Florence, MD Institut de Cancérologie de l'Ouest
PRS Account Institut Cancerologie de l'Ouest
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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