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

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ClinicalTrials.gov Identifier: NCT03975959
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle

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 Hiv 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), and in patients with HIV 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 494 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 and HIV
Actual Study Start Date : May 10, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Memory

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

HIV

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Also, for the HIV group, the patients must also:

- Have an immunologically-proven diagnosed of HIV as indicated by enzyme linked immunosorbent assay (ELISA test) and a Western Blot confirmatory test.

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 HIV group, the patients must not:

  • Have a history of cancer
  • Have reported a history of neurological diagnoses (e.g., seizure disorders, closed head injuries with loss of consciousness greater than 15 min)
  • Have reported a central nervous system neoplasms or an opportunistic infection disorders (e.g., toxoplasmosis, progressive multifocal leukoencephalopathy, neurotuberculosis)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975959


Contacts
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Contact: EMMANNUELLE TEXIER 0467613102 emmanuelle.texier@icm.unicancer.fr

Locations
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France
Icm Val D'Aurelle Recruiting
Montpellier, Herault, France, 34298
Contact: EMMANUELLE TEXIER    0467613102    emmanuelle.texier@icm.unicancer.fr   
Principal Investigator: ESTELLE GUERDOUX-NINOT         
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
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Study Director: JEAN-PIERRE BLEUSE DRCI ICM VAL D'AURELLE

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Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier: NCT03975959     History of Changes
Other Study ID Numbers: PROICM 2018-07 BPR
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle:
PROMESSE
PROSPECTIVE MEMORY
RETROSPECTIVE MEMORY

Additional relevant MeSH terms:
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Glioblastoma
Nervous System Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases