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

Primary Purpose

Glioblastoma, Glioma, Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
QMRP questionnaire
Sponsored by
Institut du Cancer de Montpellier - Val d'Aurelle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Glioblastoma focused on measuring PROMESSE, PROSPECTIVE MEMORY, RETROSPECTIVE MEMORY

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Icm Val D'AurelleRecruiting
  • CHU D'amiensRecruiting
  • UFR de Psychologie Université de LilleRecruiting
  • Hôpital d'Instruction des ArméesRecruiting
  • Hopital saint LouisRecruiting
  • CHU LyonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

GLIOBLASTOMA

glioma

breast cancer

healthy

Arm Description

One visit with collection : demographical data clinical data QMRP questionnaire HADS questionnaire MFI questionnaire MoCA test FAB test

One visit with collection : demographical data clinical data QMRP questionnaire HADS questionnaire MFI questionnaire MoCA test FAB test

One visit with collection : demographical data clinical data QMRP questionnaire HADS questionnaire MFI questionnaire MoCA test FAB test

One visit with collection : demographical data clinical data QMRP questionnaire HADS questionnaire MFI questionnaire MoCA test FAB test

Outcomes

Primary Outcome Measures

the nature of subjective memory complaints
scores from 8 to 40 of QMRP questionnaire

Secondary Outcome Measures

the significant psychopathological correlates of the subjective PM and RM complaints
Scores on the Hospital Anxiety Depression Scale from 0-21
the significant correlates between the subjective PM and RM complaints and the subjective fatigues
Scores on the Multidimensional Fatigue Inventory-20
the significant correlates between the subjective PM and RM complaints
Scores (from 0 to 30) on the Montreal Cognitive Assessment
the effect of disease on the subjective PM and RM complaints
comparison of clinical event between each group
the effect of cancer on the subjective PM and RM complaints
questionnaire : frontal assessment battery compared between each groups
the significant correlates between the subjective PM and RM complaints
questionnaire : frontal assessment battery score 0-18

Full Information

First Posted
May 27, 2019
Last Updated
June 6, 2023
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
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1. Study Identification

Unique Protocol Identification Number
NCT03975959
Brief Title
Memory Perception Assessment in Central/Non-central Nervous System Cancers
Acronym
PROMESSE
Official Title
Prospective and Retrospective Memory Perception Assessment in Central/Non-central Nervous System Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, Glioma, Breast Cancer, Healthy
Keywords
PROMESSE, PROSPECTIVE MEMORY, RETROSPECTIVE MEMORY

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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)
Allocation
Non-Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GLIOBLASTOMA
Arm Type
Other
Arm Description
One visit with collection : demographical data clinical data QMRP questionnaire HADS questionnaire MFI questionnaire MoCA test FAB test
Arm Title
glioma
Arm Type
Other
Arm Description
One visit with collection : demographical data clinical data QMRP questionnaire HADS questionnaire MFI questionnaire MoCA test FAB test
Arm Title
breast cancer
Arm Type
Other
Arm Description
One visit with collection : demographical data clinical data QMRP questionnaire HADS questionnaire MFI questionnaire MoCA test FAB test
Arm Title
healthy
Arm Type
Other
Arm Description
One visit with collection : demographical data clinical data QMRP questionnaire HADS questionnaire MFI questionnaire MoCA test FAB test
Intervention Type
Other
Intervention Name(s)
QMRP questionnaire
Other Intervention Name(s)
HADS questionnaire, MFI questionnaire, MOCA test, FAB test
Intervention Description
a single consultation for test and questionnaires for a duration of 20 minutes
Primary Outcome Measure Information:
Title
the nature of subjective memory complaints
Description
scores from 8 to 40 of QMRP questionnaire
Time Frame
12 months
Secondary Outcome Measure Information:
Title
the significant psychopathological correlates of the subjective PM and RM complaints
Description
Scores on the Hospital Anxiety Depression Scale from 0-21
Time Frame
12 months
Title
the significant correlates between the subjective PM and RM complaints and the subjective fatigues
Description
Scores on the Multidimensional Fatigue Inventory-20
Time Frame
12 months
Title
the significant correlates between the subjective PM and RM complaints
Description
Scores (from 0 to 30) on the Montreal Cognitive Assessment
Time Frame
12 months
Title
the effect of disease on the subjective PM and RM complaints
Description
comparison of clinical event between each group
Time Frame
12 months
Title
the effect of cancer on the subjective PM and RM complaints
Description
questionnaire : frontal assessment battery compared between each groups
Time Frame
12 months
Title
the significant correlates between the subjective PM and RM complaints
Description
questionnaire : frontal assessment battery score 0-18
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moussion Aurore
Phone
+33467612446
Email
aurore.moussion@icm.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Texier Emmanuelle
Phone
0467613102
Email
emmanuelle.texier@icm.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guerdoux Estelle, MD
Organizational Affiliation
ICM Co. Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
Icm Val D'Aurelle
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
EMMANUELLE TEXIER
Phone
0467613102
Email
emmanuelle.texier@icm.unicancer.fr
First Name & Middle Initial & Last Name & Degree
ESTELLE GUERDOUX
Facility Name
CHU D'amiens
City
Amiens
State/Province
Nord
ZIP/Postal Code
80080
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu BOONE, Dr
Email
boone.mathieu@chu-amiens.fr
Facility Name
UFR de Psychologie Université de Lille
City
Villeneuve-d'Ascq
State/Province
Nord
ZIP/Postal Code
59653
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine MORONI, Pr
Email
christine.moroni@univ-lille3.fr
Facility Name
Hôpital d'Instruction des Armées
City
Clamart
ZIP/Postal Code
92190
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flavie BOMPAIRE, Dr
Email
orthophoniepercy@gmail.com]
Facility Name
Hopital saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didier MAILLET, Dr
Email
didier.maillet@aphp.fr
Facility Name
CHU Lyon
City
Saint-Genis-Laval
ZIP/Postal Code
69230
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie COURTOIS, Dr
Email
sophie.courtois@chu-lyon.fr

12. IPD Sharing Statement

Plan to Share IPD
No
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Memory Perception Assessment in Central/Non-central Nervous System Cancers

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