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

NCT03975959 | Completed

• 1 other identifier: PROICM 2018-07 BPR
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 6

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

Conditions

Breast Cancer; Healthy; Glioblastoma; Glioma

Keywords

PROMESSE; PROSPECTIVE MEMORY; RETROSPECTIVE MEMORY

Outcome Measures

Primary Outcomes (1)

• the nature of subjective memory complaints

  scores from 8 to 40 of QMRP questionnaire

  12 months

Secondary Outcomes (6)

• the significant psychopathological correlates of the subjective PM and RM complaints

  12 months

• the significant correlates between the subjective PM and RM complaints and the subjective fatigues

  12 months

• the significant correlates between the subjective PM and RM complaints

  12 months

• the effect of disease on the subjective PM and RM complaints

  12 months

• the effect of cancer on the subjective PM and RM complaints

  12 months

Study Arms (4)

GLIOBLASTOMA

OTHER

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

Other: QMRP questionnaire

glioma

OTHER

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

Other: QMRP questionnaire

breast cancer

OTHER

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

Other: QMRP questionnaire

healthy

OTHER

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

Other: QMRP questionnaire

Interventions

QMRP questionnaire OTHER

a single consultation for test and questionnaires for a duration of 20 minutes

Also known as: HADS questionnaire, MFI questionnaire, MOCA test, FAB test

GLIOBLASTOMA; breast cancer; glioma; healthy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (6)

Icm Val D'Aurelle

Montpellier, Herault, 34298, France

Location

CHU D'amiens

Amiens, Nord, 80080, France

Location

UFR de Psychologie Université de Lille

Villeneuve-d'Ascq, NORD, 59653, France

Location

Hôpital d'Instruction des Armées

Clamart, 92190, France

Location

Hopital saint Louis

Paris, 75010, France

Location

CHU Lyon

Saint-Genis-Laval, 69230, France

Location

Related Publications (34)

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MeSH Terms

Conditions

Glioblastoma; Glioma; Breast Neoplasms

Interventions

4-amino-4'-hydroxylaminodiphenylsulfone

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Guerdoux Estelle, MD

  ICM Co. Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: May 27, 2019
• First Posted: June 5, 2019
• Study Start: May 10, 2019
• Primary Completion: June 27, 2024
• Study Completion: October 31, 2024
• Last Updated: June 4, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Access to study data upon written detailed request sent to ICM, from 6 months until 5 years after publication of summary data.
• Access Criteria: The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from ICM for personal access, and data will only be transferred after signing of a data access agreement.

Locations

FR (6)