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出境医 / 临床实验 / Memory Perception Assessment in Central/Non-central Nervous System Cancers (PROMESSE)

Memory Perception Assessment in Central/Non-central Nervous System Cancers (PROMESSE)

Study Description
Brief Summary:

Prospective memory (PM) is the ability to implement intended actions in the future. It allows maintaining and retrieving future plans, goals, and activities (i.e., remember to remember). PM is associated with most everyday memory problems . PM is crucial to correctly respond to all the social, occupational and working demands of everyday life, to perform many deferred health-related actions and is involved in therapeutic adherence .

Indeed, PM errors are an important part of the aging memory complaints. The prevalence of self-reported PM failures is also significant among young adults, compared with self-reported retrospective memory (RM) failures .Yet, PM errors are major sources of frustration and embarrassment .

In oncology, recently investigated the self-reported memory complaints in a 80 case-healthy-control study breast patients . Subjective memory complaints were assessed using the Prospective and Retrospective Memory Questionnaire . Results from the Paquet et al. study show that all participants (i.e., both patients and matched-controls) reported more PM than RM failures in daily-life (p<.001). Breast cancer patients reported more RM and PM failures than controls. However, this group effect was no longer statistically significant when controlling for depression and fatigue.

These findings are consistent with the view that memory complaints are closely associated with depression and cancer-related fatigue, and more generally with psychopathological variables .As underlined by Paquet et al. subjective memory complaints should be investigated because they refer to some aspects of the cancer experience that could potentially be linked to quality of life. Thus, it is important to explore psychopathological basis such as depression, anxiety and fatigue while investigating self-reported memory failures in cancer patients.

Despites the importance of PM, there have been, to our knowledge, only few studies evaluating PM complaints or PM functioning in patients diagnosed with an intracerebral tumor (such as Diffuse Low-Grade Glioma- DLGG- or glioblastome- GB) or extra-cerebral tumor (such as breast cancer - BC). Therefore, the investigators thought it would be useful, as a first step, to conduct a study to explore and to manage the PM and RM subjective complaints in cancer patients compared to another chronic disease, such as HIV. In fine, these data will help to identify a new target for psychological management focused on either psychopathological or neuropsychological rehabilitation


Condition or disease Intervention/treatment Phase
Glioblastoma Glioma Breast Cancer Healthy Other: QMRP questionnaire Not Applicable

Detailed Description:

Primary objective :

This study will aim at determining the nature of subjective memory complaints (i.e., prospective or retrospective memory) in cancer patients with intra- cerebral tumors (Glioblastomas and Diffuse Low Grade Gliomas) and extra cerebral tumors (Breast cancer) compared with controls.

The protocol administration will take about 20 minutes. It will be conducted by an experienced clinical neuropsychologist or clinical oncologist in each center during standard care. According to the results on the questionnaires and test, patients will be addressed and managed by a neuropsychologist, a clinical psychologist, psychiatrist or a speech therapist.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: The protocol administration will take about 20 minutes. It will be conducted by an experienced clinical neuropsychologist or clinical oncologist in each center during standard care. According to the results on the questionnaires and test, patients will be addressed and managed by a neuropsychologist, a clinical psychologist, psychiatrist or a speech therapist.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prospective and Retrospective Memory Perception Assessment in Central/Non-central Nervous System Cancers
Actual Study Start Date : May 10, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : April 30, 2022
Arms and Interventions
Arm Intervention/treatment
GLIOBLASTOMA

One visit with collection :

demographical data clinical data QMRP questionnaire HADS questionnaire MFI questionnaire MoCA test FAB test

Other: QMRP questionnaire
a single consultation for test and questionnaires for a duration of 20 minutes
Other Names:
  • HADS questionnaire
  • MFI questionnaire
  • MOCA test
  • FAB test

glioma

One visit with collection :

demographical data clinical data QMRP questionnaire HADS questionnaire MFI questionnaire MoCA test FAB test

Other: QMRP questionnaire
a single consultation for test and questionnaires for a duration of 20 minutes
Other Names:
  • HADS questionnaire
  • MFI questionnaire
  • MOCA test
  • FAB test

breast cancer

One visit with collection :

demographical data clinical data QMRP questionnaire HADS questionnaire MFI questionnaire MoCA test FAB test

Other: QMRP questionnaire
a single consultation for test and questionnaires for a duration of 20 minutes
Other Names:
  • HADS questionnaire
  • MFI questionnaire
  • MOCA test
  • FAB test

healthy

One visit with collection :

demographical data clinical data QMRP questionnaire HADS questionnaire MFI questionnaire MoCA test FAB test

Other: QMRP questionnaire
a single consultation for test and questionnaires for a duration of 20 minutes
Other Names:
  • HADS questionnaire
  • MFI questionnaire
  • MOCA test
  • FAB test

Outcome Measures
Primary Outcome Measures :
  1. the nature of subjective memory complaints [ Time Frame: 12 months ]
    scores from 8 to 40 of QMRP questionnaire


Secondary Outcome Measures :
  1. the significant psychopathological correlates of the subjective PM and RM complaints [ Time Frame: 12 months ]
    Scores on the Hospital Anxiety Depression Scale from 0-21

  2. the significant correlates between the subjective PM and RM complaints and the subjective fatigues [ Time Frame: 12 months ]
    Scores on the Multidimensional Fatigue Inventory-20

  3. the significant correlates between the subjective PM and RM complaints [ Time Frame: 12 months ]
    Scores (from 0 to 30) on the Montreal Cognitive Assessment

  4. the effect of disease on the subjective PM and RM complaints [ Time Frame: 12 months ]
    comparison of clinical event between each group

  5. the effect of cancer on the subjective PM and RM complaints [ Time Frame: 12 months ]
    questionnaire : frontal assessment battery compared between each groups

  6. the significant correlates between the subjective PM and RM complaints [ Time Frame: 12 months ]
    questionnaire : frontal assessment battery score 0-18


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All the participants must fulfill all the following criteria to be eligible for study entry:

  • Be aged of 18 to 80 years old
  • Have a ECOG Performance Status ≤ 2 or a Karnofsky index ≥ 50 %
  • Have a satisfactory level of French
  • Have signed the informed consent

Also, for the DLGG group, the patients must:

  • Have a histologically-proven diagnosis of DLGG (i.e., WHO grade II glioma)
  • Receive or have received a first oncological treatment after surgery (chemotherapy, radiation therapy…)

Also, for the GB group, the patients must:

- Have a histologically-proven diagnosis of GB (i.e., WHO grade IV glioma).

Also, for the breast cancer group, the patients must:

- Have a histologically-proven diagnosis of breast cancer diagnosed < 2 years.

Exclusion Criteria:

Participants presenting with any of the following exclusion criteria will not be included in the study:

  • Patients with brain metastases
  • Patients under tutorship or curatorship or protective measures
  • Patients suffering from sensorial or motor deficits avoiding the tests administration
  • Patients with a reported history of psychiatric disease (e.g., mental retardation, psychotic disorders, learning disabilities, attention-deficit/hyperactivity disorder, and bipolar disorder)
  • Have reported a substance dependence within the past six months (e.g., cocaine or methamphetamine dependence)
  • Pregnant women
  • Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to sign the informed consent or to terminate the study

Also, for the DLGG group, the patients must not:

  • Have an anaplastic glioma (i.e., WHO grade III glioma)
  • Have a DLGG with radiological or histological signs of anaplastic transformation
  • Have a history of HIV
  • Have a history of other cancer

Also, for the GB group, the patients must not:

  • Patients treated with ≥2 lines of systemic cancer treatment (e.g., patient after the first GB recurrence)
  • Have a history of HIV
  • Have a history of other cancer

Also, for the breast cancer group, the patients must not:

  • Have a metastatic disease
  • Have a neoadjuvant therapy
  • Have a documented neurological, or substance use disorders.
  • Have a history of HIV
  • Have a history of other cancer
  • Have reported a history of neurological diagnoses (e.g., seizure disorders, closed head injuries with loss of consciousness greater than 15 min).

Also for the control group, the participants must not:

  • Have a documented neurological, or substance use disorders
  • Have a history of cancer
  • Have a history of HIV
Contacts and Locations

Contacts
Layout table for location contacts
Contact: EMMANNUELLE TEXIER 0467613102 emmanuelle.texier@icm.unicancer.fr

Locations
Layout table for location information
France
Icm Val D'Aurelle Recruiting
Montpellier, Herault, France, 34298
Contact: EMMANUELLE TEXIER    0467613102    emmanuelle.texier@icm.unicancer.fr   
Principal Investigator: ESTELLE GUERDOUX         
CHU D'amiens Recruiting
Amiens, Nord, France, 80080
Contact: Mathieu BOONE, Dr       boone.mathieu@chu-amiens.fr   
UFR de Psychologie Université de Lille Recruiting
Villeneuve-d'Ascq, Nord, France, 59653
Contact: Christine MORONI, Pr       christine.moroni@univ-lille3.fr   
Hôpital d'Instruction des Armées Recruiting
Clamart, France, 92190
Contact: Flavie BOMPAIRE, Dr       orthophoniepercy@gmail.com]   
Hopital saint Louis Recruiting
Paris, France, 75010
Contact: Didier MAILLET, Dr       didier.maillet@aphp.fr   
Hopital PItie Salpétrière Recruiting
Paris, France, 75013
Contact: Monica RIBEIRO, MRS       crmonica@gmail.com   
CHU Lyon Recruiting
Saint-Genis-Laval, France, 69230
Contact: Sophie COURTOIS, Dr       sophie.courtois@chu-lyon.fr   
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
Layout table for investigator information
Study Director: JEAN-PIERRE BLEUSE DRCI ICM VAL D'AURELLE
Tracking Information
First Submitted Date  ICMJE May 27, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date May 19, 2021
Actual Study Start Date  ICMJE May 10, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
the nature of subjective memory complaints [ Time Frame: 12 months ]
scores from 8 to 40 of QMRP questionnaire
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • the significant psychopathological correlates of the subjective PM and RM complaints [ Time Frame: 12 months ]
    Scores on the Hospital Anxiety Depression Scale from 0-21
  • the significant correlates between the subjective PM and RM complaints and the subjective fatigues [ Time Frame: 12 months ]
    Scores on the Multidimensional Fatigue Inventory-20
  • the significant correlates between the subjective PM and RM complaints [ Time Frame: 12 months ]
    Scores (from 0 to 30) on the Montreal Cognitive Assessment
  • the effect of disease on the subjective PM and RM complaints [ Time Frame: 12 months ]
    comparison of clinical event between each group
  • the effect of cancer on the subjective PM and RM complaints [ Time Frame: 12 months ]
    questionnaire : frontal assessment battery compared between each groups
  • the significant correlates between the subjective PM and RM complaints [ Time Frame: 12 months ]
    questionnaire : frontal assessment battery score 0-18
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 Memory Perception Assessment in Central/Non-central Nervous System Cancers
Official Title  ICMJE Prospective and Retrospective Memory Perception Assessment in Central/Non-central Nervous System Cancers
Brief Summary

Prospective memory (PM) is the ability to implement intended actions in the future. It allows maintaining and retrieving future plans, goals, and activities (i.e., remember to remember). PM is associated with most everyday memory problems . PM is crucial to correctly respond to all the social, occupational and working demands of everyday life, to perform many deferred health-related actions and is involved in therapeutic adherence .

Indeed, PM errors are an important part of the aging memory complaints. The prevalence of self-reported PM failures is also significant among young adults, compared with self-reported retrospective memory (RM) failures .Yet, PM errors are major sources of frustration and embarrassment .

In oncology, recently investigated the self-reported memory complaints in a 80 case-healthy-control study breast patients . Subjective memory complaints were assessed using the Prospective and Retrospective Memory Questionnaire . Results from the Paquet et al. study show that all participants (i.e., both patients and matched-controls) reported more PM than RM failures in daily-life (p<.001). Breast cancer patients reported more RM and PM failures than controls. However, this group effect was no longer statistically significant when controlling for depression and fatigue.

These findings are consistent with the view that memory complaints are closely associated with depression and cancer-related fatigue, and more generally with psychopathological variables .As underlined by Paquet et al. subjective memory complaints should be investigated because they refer to some aspects of the cancer experience that could potentially be linked to quality of life. Thus, it is important to explore psychopathological basis such as depression, anxiety and fatigue while investigating self-reported memory failures in cancer patients.

Despites the importance of PM, there have been, to our knowledge, only few studies evaluating PM complaints or PM functioning in patients diagnosed with an intracerebral tumor (such as Diffuse Low-Grade Glioma- DLGG- or glioblastome- GB) or extra-cerebral tumor (such as breast cancer - BC). Therefore, the investigators thought it would be useful, as a first step, to conduct a study to explore and to manage the PM and RM subjective complaints in cancer patients compared to another chronic disease, such as HIV. In fine, these data will help to identify a new target for psychological management focused on either psychopathological or neuropsychological rehabilitation

Detailed Description

Primary objective :

This study will aim at determining the nature of subjective memory complaints (i.e., prospective or retrospective memory) in cancer patients with intra- cerebral tumors (Glioblastomas and Diffuse Low Grade Gliomas) and extra cerebral tumors (Breast cancer) compared with controls.

The protocol administration will take about 20 minutes. It will be conducted by an experienced clinical neuropsychologist or clinical oncologist in each center during standard care. According to the results on the questionnaires and test, patients will be addressed and managed by a neuropsychologist, a clinical psychologist, psychiatrist or a speech therapist.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
The protocol administration will take about 20 minutes. It will be conducted by an experienced clinical neuropsychologist or clinical oncologist in each center during standard care. According to the results on the questionnaires and test, patients will be addressed and managed by a neuropsychologist, a clinical psychologist, psychiatrist or a speech therapist.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Glioblastoma
  • Glioma
  • Breast Cancer
  • Healthy
Intervention  ICMJE Other: QMRP questionnaire
a single consultation for test and questionnaires for a duration of 20 minutes
Other Names:
  • HADS questionnaire
  • MFI questionnaire
  • MOCA test
  • FAB test
Study Arms  ICMJE
  • GLIOBLASTOMA

    One visit with collection :

    demographical data clinical data QMRP questionnaire HADS questionnaire MFI questionnaire MoCA test FAB test

    Intervention: Other: QMRP questionnaire
  • glioma

    One visit with collection :

    demographical data clinical data QMRP questionnaire HADS questionnaire MFI questionnaire MoCA test FAB test

    Intervention: Other: QMRP questionnaire
  • breast cancer

    One visit with collection :

    demographical data clinical data QMRP questionnaire HADS questionnaire MFI questionnaire MoCA test FAB test

    Intervention: Other: QMRP questionnaire
  • healthy

    One visit with collection :

    demographical data clinical data QMRP questionnaire HADS questionnaire MFI questionnaire MoCA test FAB test

    Intervention: Other: QMRP questionnaire
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 17, 2021)
420
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2019)
494
Estimated Study Completion Date  ICMJE April 30, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

All the participants must fulfill all the following criteria to be eligible for study entry:

  • Be aged of 18 to 80 years old
  • Have a ECOG Performance Status ≤ 2 or a Karnofsky index ≥ 50 %
  • Have a satisfactory level of French
  • Have signed the informed consent

Also, for the DLGG group, the patients must:

  • Have a histologically-proven diagnosis of DLGG (i.e., WHO grade II glioma)
  • Receive or have received a first oncological treatment after surgery (chemotherapy, radiation therapy…)

Also, for the GB group, the patients must:

- Have a histologically-proven diagnosis of GB (i.e., WHO grade IV glioma).

Also, for the breast cancer group, the patients must:

- Have a histologically-proven diagnosis of breast cancer diagnosed < 2 years.

Exclusion Criteria:

Participants presenting with any of the following exclusion criteria will not be included in the study:

  • Patients with brain metastases
  • Patients under tutorship or curatorship or protective measures
  • Patients suffering from sensorial or motor deficits avoiding the tests administration
  • Patients with a reported history of psychiatric disease (e.g., mental retardation, psychotic disorders, learning disabilities, attention-deficit/hyperactivity disorder, and bipolar disorder)
  • Have reported a substance dependence within the past six months (e.g., cocaine or methamphetamine dependence)
  • Pregnant women
  • Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to sign the informed consent or to terminate the study

Also, for the DLGG group, the patients must not:

  • Have an anaplastic glioma (i.e., WHO grade III glioma)
  • Have a DLGG with radiological or histological signs of anaplastic transformation
  • Have a history of HIV
  • Have a history of other cancer

Also, for the GB group, the patients must not:

  • Patients treated with ≥2 lines of systemic cancer treatment (e.g., patient after the first GB recurrence)
  • Have a history of HIV
  • Have a history of other cancer

Also, for the breast cancer group, the patients must not:

  • Have a metastatic disease
  • Have a neoadjuvant therapy
  • Have a documented neurological, or substance use disorders.
  • Have a history of HIV
  • Have a history of other cancer
  • Have reported a history of neurological diagnoses (e.g., seizure disorders, closed head injuries with loss of consciousness greater than 15 min).

Also for the control group, the participants must not:

  • Have a documented neurological, or substance use disorders
  • Have a history of cancer
  • Have a history of HIV
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: EMMANNUELLE TEXIER 0467613102 emmanuelle.texier@icm.unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03975959
Other Study ID Numbers  ICMJE PROICM 2018-07 BPR
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
Plan to Share IPD: No
Responsible Party Institut du Cancer de Montpellier - Val d'Aurelle
Study Sponsor  ICMJE Institut du Cancer de Montpellier - Val d'Aurelle
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: JEAN-PIERRE BLEUSE DRCI ICM VAL D'AURELLE
PRS Account Institut du Cancer de Montpellier - Val d'Aurelle
Verification Date May 2021

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

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