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

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle (Other)

Overall Status

Recruiting

CT.gov ID

NCT03975959

Collaborator

(none)

420

Enrollment

Locations

Arms

53.7

Anticipated Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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.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

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Oct 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: 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
Other: 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
Other: 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
Other: 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

the nature of subjective memory complaints [12 months]
scores from 8 to 40 of QMRP questionnaire

Secondary Outcome Measures

the significant psychopathological correlates of the subjective PM and RM complaints [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 [12 months]
Scores on the Multidimensional Fatigue Inventory-20
the significant correlates between the subjective PM and RM complaints [12 months]
Scores (from 0 to 30) on the Montreal Cognitive Assessment
the effect of disease on the subjective PM and RM complaints [12 months]
comparison of clinical event between each group
the effect of cancer on the subjective PM and RM complaints [12 months]
questionnaire : frontal assessment battery compared between each groups
the significant correlates between the subjective PM and RM complaints [12 months]
questionnaire : frontal assessment battery score 0-18

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Icm Val D'Aurelle	Montpellier	Herault	France	34298
2	CHU D'amiens	Amiens	Nord	France	80080
3	UFR de Psychologie Université de Lille	Villeneuve-d'Ascq	Nord	France	59653
4	Hôpital d'Instruction des Armées	Clamart		France	92190
5	Hopital saint Louis	Paris		France	75010
6	CHU Lyon	Saint-Genis-Laval		France	69230

Sponsors and Collaborators

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

Study Director: JEAN-PIERRE BLEUSE, DRCI ICM VAL D'AURELLE

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Institut du Cancer de Montpellier - Val d'Aurelle

ClinicalTrials.gov Identifier:

NCT03975959

Other Study ID Numbers:

PROICM 2018-07 BPR

First Posted:

Jun 5, 2019

Last Update Posted:

Aug 3, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle

PROMESSE

PROSPECTIVE MEMORY

RETROSPECTIVE MEMORY

Additional relevant MeSH terms:

Glioblastoma

Nervous System Neoplasms

Study Results

No Results Posted as of Aug 3, 2022