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

June 6, 2023 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the nature of subjective memory complaints
Time Frame: 12 months
scores from 8 to 40 of QMRP questionnaire
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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
12 months
the significant correlates between the subjective PM and RM complaints
Time Frame: 12 months
Scores (from 0 to 30) on the Montreal Cognitive Assessment
12 months
the effect of disease on the subjective PM and RM complaints
Time Frame: 12 months
comparison of clinical event between each group
12 months
the effect of cancer on the subjective PM and RM complaints
Time Frame: 12 months
questionnaire : frontal assessment battery compared between each groups
12 months
the significant correlates between the subjective PM and RM complaints
Time Frame: 12 months
questionnaire : frontal assessment battery score 0-18
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: Guerdoux Estelle, MD, ICM Co. Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2019

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

May 27, 2019

First Submitted That Met QC Criteria

June 4, 2019

First Posted (Actual)

June 5, 2019

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROICM 2018-07 BPR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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