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 | Not Applicable |
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 (Clinical Trial) |
Estimated 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. |
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 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | April 30, 2022 |
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:
|
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:
|
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:
|
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:
|
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
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:
Also, for the DLGG group, the patients must:
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:
Also, for the DLGG group, the patients must not:
Also, for the GB group, the patients must not:
Also, for the breast cancer group, the patients must not:
Also for the control group, the participants must not:
Contact: EMMANNUELLE TEXIER | 0467613102 | emmanuelle.texier@icm.unicancer.fr |
France | |
Icm Val D'Aurelle | Recruiting |
Montpellier, Herault, France, 34298 | |
Contact: EMMANUELLE TEXIER 0467613102 emmanuelle.texier@icm.unicancer.fr | |
Principal Investigator: ESTELLE GUERDOUX | |
CHU D'amiens | Recruiting |
Amiens, Nord, France, 80080 | |
Contact: Mathieu BOONE, Dr boone.mathieu@chu-amiens.fr | |
UFR de Psychologie Université de Lille | Recruiting |
Villeneuve-d'Ascq, Nord, France, 59653 | |
Contact: Christine MORONI, Pr christine.moroni@univ-lille3.fr | |
Hôpital d'Instruction des Armées | Recruiting |
Clamart, France, 92190 | |
Contact: Flavie BOMPAIRE, Dr orthophoniepercy@gmail.com] | |
Hopital saint Louis | Recruiting |
Paris, France, 75010 | |
Contact: Didier MAILLET, Dr didier.maillet@aphp.fr | |
Hopital PItie Salpétrière | Recruiting |
Paris, France, 75013 | |
Contact: Monica RIBEIRO, MRS crmonica@gmail.com | |
CHU Lyon | Recruiting |
Saint-Genis-Laval, France, 69230 | |
Contact: Sophie COURTOIS, Dr sophie.courtois@chu-lyon.fr |
Study Director: | JEAN-PIERRE BLEUSE | DRCI ICM VAL D'AURELLE |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | May 27, 2019 | ||||
First Posted Date ICMJE | June 5, 2019 | ||||
Last Update Posted Date | May 19, 2021 | ||||
Actual Study Start Date ICMJE | May 10, 2019 | ||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
the nature of subjective memory complaints [ Time Frame: 12 months ] scores from 8 to 40 of QMRP questionnaire
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Memory Perception Assessment in Central/Non-central Nervous System Cancers | ||||
Official Title ICMJE | Prospective and Retrospective Memory Perception Assessment in Central/Non-central Nervous System Cancers | ||||
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 |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | 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 |
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Condition ICMJE |
|
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Intervention ICMJE | Other: QMRP questionnaire
a single consultation for test and questionnaires for a duration of 20 minutes
Other Names:
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
420 | ||||
Original Estimated Enrollment ICMJE |
494 | ||||
Estimated Study Completion Date ICMJE | April 30, 2022 | ||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria: All the participants must fulfill all the following criteria to be eligible for study entry:
Also, for the DLGG group, the patients must:
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:
Also, for the DLGG group, the patients must not:
Also, for the GB group, the patients must not:
Also, for the breast cancer group, the patients must not:
Also for the control group, the participants must not:
|
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03975959 | ||||
Other Study ID Numbers ICMJE | PROICM 2018-07 BPR | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Institut du Cancer de Montpellier - Val d'Aurelle | ||||
Study Sponsor ICMJE | Institut du Cancer de Montpellier - Val d'Aurelle | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Institut du Cancer de Montpellier - Val d'Aurelle | ||||
Verification Date | May 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |