GlioblastomaPROMESSENCT03975959
Memory Perception Assessment in Central/Non-central Nervous System Cancers
A study testing QMRP questionnaire in people with Glioblastoma and Glioma, run by Institut du Cancer de Montpellier - Val d'Aurelle at 6 sites in France.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glioblastoma, Glioma, Breast Cancer
- What is being tested?
- QMRP questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 426 participants
- Where
- 6 sitesFrance
- Study dates
- 10 May 2019to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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.
Who cannot join
- 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)
Show all 28Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU D'amiens
Amiens, Nord, 80080
Hôpital d'Instruction des Armées
Clamart, 92190
Icm Val D'Aurelle
Montpellier, Herault, 34298
Hopital saint Louis
Paris, 75010
CHU Lyon
Saint-Genis-Laval, 69230
UFR de Psychologie Université de Lille
Villeneuve-d'Ascq, NORD, 59653
About this study
Official title: 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 .
Read more
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
Read the 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.
- Conditions
- Glioblastoma, Glioma, Breast Cancer, Healthy
- Being tested
- QMRP questionnaire
- Keywords
- PROMESSE, PROSPECTIVE MEMORY, RETROSPECTIVE MEMORY
- Medical subject headings
- Glioblastoma, Glioma, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QMRP questionnaireOther
Also called HADS questionnaire, MFI questionnaire, MOCA test, FAB test
a single consultation for test and questionnaires for a duration of 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| GLIOBLASTOMA | Other | One visit with collection :
demographical data clinical data QMRP questionnaire HADS questionnaire MFI questionnaire MoCA test FAB test Receives: Other: QMRP questionnaire |
| glioma | Other | One visit with collection :
demographical data clinical data QMRP questionnaire HADS questionnaire MFI questionnaire MoCA test FAB test Receives: Other: QMRP questionnaire |
| breast cancer | Other | One visit with collection :
demographical data clinical data QMRP questionnaire HADS questionnaire MFI questionnaire MoCA test FAB test Receives: Other: QMRP questionnaire |
| healthy | Other | One visit with collection :
demographical data clinical data QMRP questionnaire HADS questionnaire MFI questionnaire MoCA test FAB test Receives: Other: QMRP questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
the nature of subjective memory complaints
scores from 8 to 40 of QMRP questionnaire
Measured: 12 months
Secondary outcomes (6)
the significant psychopathological correlates of the subjective PM and RM complaints
Scores on the Hospital Anxiety Depression Scale from 0-21
Measured: 12 months
the significant correlates between the subjective PM and RM complaints and the subjective fatigues
Scores on the Multidimensional Fatigue Inventory-20
Measured: 12 months
the significant correlates between the subjective PM and RM complaints
Scores (from 0 to 30) on the Montreal Cognitive Assessment
Measured: 12 months
the effect of disease on the subjective PM and RM complaints
comparison of clinical event between each group
Measured: 12 months
the effect of cancer on the subjective PM and RM complaints
questionnaire : frontal assessment battery compared between each groups
Measured: 12 months
the significant correlates between the subjective PM and RM complaints
questionnaire : frontal assessment battery score 0-18
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start10 May 2019
- Primary completion27 Jun 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- 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)
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guerdoux Estelle, MD, Study chair, ICM Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975959
- Sponsor's protocol ID
- PROICM 2018-07 BPR
- Acronym
- PROMESSE
- Status last verified
- Jun 2025
- First submitted
- 27 May 2019
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.
Publications
Bedard M, Verma S, Collins B, Song X, Paquet L. Prospective memory impairment in chemotherapy-exposed early breast cancer survivors: Preliminary evidence from a clinical test. J Psychosoc Oncol. 2016 Jul-Aug;34(4):291-304. doi: 10.1080/07347332.2016.1181133. Epub 2016 Apr 28.
PubMed 27123566Boone M, Roussel M, Chauffert B, Le Gars D, Godefroy O. Prevalence and profile of cognitive impairment in adult glioma: a sensitivity analysis. J Neurooncol. 2016 Aug;129(1):123-30. doi: 10.1007/s11060-016-2152-7. Epub 2016 May 30.
PubMed 27241133Brem S, Meyers CA, Palmer G, Booth-Jones M, Jain S, Ewend MG. Preservation of neurocognitive function and local control of 1 to 3 brain metastases treated with surgery and carmustine wafers. Cancer. 2013 Nov 1;119(21):3830-8. doi: 10.1002/cncr.28307. Epub 2013 Aug 23.
PubMed 24037801Cheng H, Yang Z, Dong B, Chen C, Zhang M, Huang Z, Chen Z, Wang K. Chemotherapy-induced prospective memory impairment in patients with breast cancer. Psychooncology. 2013 Oct;22(10):2391-5. doi: 10.1002/pon.3291. Epub 2013 May 15.
PubMed 23674402Crawford JR, Henry JD, Ward AL, Blake J. The Prospective and Retrospective Memory Questionnaire (PRMQ): latent structure, normative data and discrepancy analysis for proxy-ratings. Br J Clin Psychol. 2006 Mar;45(Pt 1):83-104. doi: 10.1348/014466505X28748.
PubMed 16480568de Frias CM, Dixon RA, Backman L. Use of memory compensation strategies is related to psychosocial and health indicators. J Gerontol B Psychol Sci Soc Sci. 2003 Jan;58(1):P12-22. doi: 10.1093/geronb/58.1.p12.
PubMed 12496297Dieckmann P, Reddersen S, Wehner T, Rall M. Prospective memory failures as an unexplored threat to patient safety: results from a pilot study using patient simulators to investigate the missed execution of intentions. Ergonomics. 2006 Apr 15-May 15;49(5-6):526-43. doi: 10.1080/00140130600568782.
PubMed 16717009Dubois B, Slachevsky A, Litvan I, Pillon B. The FAB: a Frontal Assessment Battery at bedside. Neurology. 2000 Dec 12;55(11):1621-6. doi: 10.1212/wnl.55.11.1621.
PubMed 11113214Fleming J, Ownsworth T, Doig E, Hutton L, Griffin J, Kendall M, Shum DH. The efficacy of prospective memory rehabilitation plus metacognitive skills training for adults with traumatic brain injury: study protocol for a randomized controlled trial. Trials. 2017 Jan 5;18(1):3. doi: 10.1186/s13063-016-1758-6.
PubMed 28057075Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
PubMed 1202204Gentile S, Delaroziere JC, Favre F, Sambuc R, San Marco JL. Validation of the French 'multidimensional fatigue inventory' (MFI 20). Eur J Cancer Care (Engl). 2003 Mar;12(1):58-64. doi: 10.1046/j.1365-2354.2003.00295.x.
PubMed 12641557Gonneaud J, Kalpouzos G, Bon L, Viader F, Eustache F, Desgranges B. Distinct and shared cognitive functions mediate event- and time-based prospective memory impairment in normal ageing. Memory. 2011 May;19(4):360-77. doi: 10.1080/09658211.2011.570765.
PubMed 21678154Guerdoux E, Dressaire D, Martin S, Adam S, Brouillet D. Habit and recollection in healthy aging, mild cognitive impairment, and Alzheimer's disease. Neuropsychology. 2012 Jul;26(4):517-33. doi: 10.1037/a0028718. Epub 2012 May 28.
PubMed 22642394Guerdoux E, Martin S, Dressaire D, Adam S, Brouillet D. [Memory controlled processes between the young and old: the birth of cognitive complaint?]. Can J Aging. 2009 Mar;28(1):5-20. doi: 10.1017/S0714980809090023. French.
PubMed 19860963Herrmann C. International experiences with the Hospital Anxiety and Depression Scale--a review of validation data and clinical results. J Psychosom Res. 1997 Jan;42(1):17-41. doi: 10.1016/s0022-3999(96)00216-4.
PubMed 9055211
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Retrospective Memory Perception Assessment in Central/Non-central Nervous System Cancers
- ClinicalTrials.gov ID
- NCT03975959
- Acronym / sponsor ID
- PROMESSE / PROICM 2018-07 BPR
- Conditions
- Glioblastoma, Glioma, Breast Cancer, Healthy
- Keywords
- PROMESSE, PROSPECTIVE MEMORY, RETROSPECTIVE MEMORY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| GLIOBLASTOMA | Other | Other: QMRP questionnaireOne visit with collection : demographical data clinical data QMRP questionnaire HADS questionnaire MFI questionnaire MoCA test FAB test |
| glioma | Other | Other: QMRP questionnaireOne visit with collection : demographical data clinical data QMRP questionnaire HADS questionnaire MFI questionnaire MoCA test FAB test |
| breast cancer | Other | Other: QMRP questionnaireOne visit with collection : demographical data clinical data QMRP questionnaire HADS questionnaire MFI questionnaire MoCA test FAB test |
| healthy | Other | Other: QMRP questionnaireOne visit with collection : demographical data clinical data QMRP questionnaire HADS questionnaire MFI questionnaire MoCA test FAB test |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (28 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QMRP questionnaireAlso: HADS questionnaire, MFI questionnaire, MOCA test, FAB testa single consultation for test and questionnaires for a duration of 20 minutes | Other | GLIOBLASTOMA, breast cancer, glioma, healthy |
Primary outcome
the nature of subjective memory complaints
Time frame: 12 months
scores from 8 to 40 of QMRP questionnaire
6 secondary outcomes
the significant psychopathological correlates of the subjective PM and RM complaints
Time frame: 12 months
the significant correlates between the subjective PM and RM complaints and the subjective fatigues
Time frame: 12 months
the significant correlates between the subjective PM and RM complaints
Time frame: 12 months
the effect of disease on the subjective PM and RM complaints
Time frame: 12 months
the effect of cancer on the subjective PM and RM complaints
Time frame: 12 months
the significant correlates between the subjective PM and RM complaints
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Background: PubMed 27123566Bedard M, Verma S, Collins B, Song X, Paquet L. Prospective memory impairment in chemotherapy-exposed early breast cancer survivors: Preliminary evidence from a clinical test. J Psychosoc Oncol. 2016 Jul-Aug;34(4):291-304. doi: 10.1080/07347332.2016.1181133. Epub 2016 Apr 28.
- Background: PubMed 27241133Boone M, Roussel M, Chauffert B, Le Gars D, Godefroy O. Prevalence and profile of cognitive impairment in adult glioma: a sensitivity analysis. J Neurooncol. 2016 Aug;129(1):123-30. doi: 10.1007/s11060-016-2152-7. Epub 2016 May 30.
- Background: PubMed 24037801Brem S, Meyers CA, Palmer G, Booth-Jones M, Jain S, Ewend MG. Preservation of neurocognitive function and local control of 1 to 3 brain metastases treated with surgery and carmustine wafers. Cancer. 2013 Nov 1;119(21):3830-8. doi: 10.1002/cncr.28307. Epub 2013 Aug 23.
- Background: PubMed 23674402Cheng H, Yang Z, Dong B, Chen C, Zhang M, Huang Z, Chen Z, Wang K. Chemotherapy-induced prospective memory impairment in patients with breast cancer. Psychooncology. 2013 Oct;22(10):2391-5. doi: 10.1002/pon.3291. Epub 2013 May 15.
- Background: PubMed 16480568Crawford JR, Henry JD, Ward AL, Blake J. The Prospective and Retrospective Memory Questionnaire (PRMQ): latent structure, normative data and discrepancy analysis for proxy-ratings. Br J Clin Psychol. 2006 Mar;45(Pt 1):83-104. doi: 10.1348/014466505X28748.
- Background: PubMed 12496297de Frias CM, Dixon RA, Backman L. Use of memory compensation strategies is related to psychosocial and health indicators. J Gerontol B Psychol Sci Soc Sci. 2003 Jan;58(1):P12-22. doi: 10.1093/geronb/58.1.p12.
- Background: PubMed 16717009Dieckmann P, Reddersen S, Wehner T, Rall M. Prospective memory failures as an unexplored threat to patient safety: results from a pilot study using patient simulators to investigate the missed execution of intentions. Ergonomics. 2006 Apr 15-May 15;49(5-6):526-43. doi: 10.1080/00140130600568782.
- Background: PubMed 11113214Dubois B, Slachevsky A, Litvan I, Pillon B. The FAB: a Frontal Assessment Battery at bedside. Neurology. 2000 Dec 12;55(11):1621-6. doi: 10.1212/wnl.55.11.1621.
- Background: PubMed 28057075Fleming J, Ownsworth T, Doig E, Hutton L, Griffin J, Kendall M, Shum DH. The efficacy of prospective memory rehabilitation plus metacognitive skills training for adults with traumatic brain injury: study protocol for a randomized controlled trial. Trials. 2017 Jan 5;18(1):3. doi: 10.1186/s13063-016-1758-6.
- Background: PubMed 1202204Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
- Background: PubMed 12641557Gentile S, Delaroziere JC, Favre F, Sambuc R, San Marco JL. Validation of the French 'multidimensional fatigue inventory' (MFI 20). Eur J Cancer Care (Engl). 2003 Mar;12(1):58-64. doi: 10.1046/j.1365-2354.2003.00295.x.
- Background: PubMed 21678154Gonneaud J, Kalpouzos G, Bon L, Viader F, Eustache F, Desgranges B. Distinct and shared cognitive functions mediate event- and time-based prospective memory impairment in normal ageing. Memory. 2011 May;19(4):360-77. doi: 10.1080/09658211.2011.570765.
- Individual participant dataSharing planned: Yes. All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guerdoux Estelle, MD study chair
ICM Co. Ltd.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QMRP questionnaire in people with Glioblastoma and Glioma, run by Institut du Cancer de Montpellier - Val d'Aurelle at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the nature of subjective memory complaints (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03975959, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.