MetamemoryNCT02212132
Relations Between Cognitive Complaints and Cognitive Scores Goals in Cancer: Assessment of Metamemory
An observational study of Metamemory and Memory Complaints, run by Centre Francois Baclesse at 1 site in France.
Trial summary
This pilot study is, in this new and original approach in cancer pathology, measure and explain the correspondence between perceived cognitive impairment (cognitive complaint) by cancer patients and their cognitive scores goals with tasks metamemory while controlling the anxiety and depression and fatigue factors of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metamemory, Memory Complaints, Performance Mnemonic
- What is being tested?
- behavioral assessments
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Aug 2015
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient being treated for a solid tumor or hematological
Who may be able to join
- Patient being treated for a solid or hematologic malignancy;
- Patients under 65 years of age;
- Patients Grade 3 'end primary school "minimum (scale Barbizet);
- Primary cancer of the central nervous system or brain metastases Absence;
- No major cognitive disorders;
- Lack of previous neurological;
- Lack of personality disorders and evolutionary psychiatric pathology.
Who cannot join
- Patients with paraneoplastic syndrome;
- Scalable psychiatric pathology;
- Refusal to participate;
- Patients unable to meet the cognitive tests;
- Use of drugs;
- Heavy drinking.
Trial locations and contacts
1 site in 1 country.
About this study
This pilot study is, in this new and original approach in cancer pathology, measure and explain the correspondence between perceived cognitive impairment (cognitive complaint) by cancer patients and their cognitive scores goals with tasks metamemory while controlling the anxiety and depression and fatigue factors of patients.
Read the detailed description
The relationship between performance from neuropsychological tests and subjective complaints of cancer patients treated with chemotherapy or adjuvant hormone therapy is not clear, many studies have reported no significant correlation between these two measures: the perception of patients' their cognitive deficits is generally increased relative to that which is measured by neuropsychological testing.
The reason for this lack of association found is probably multifactorial. 1) It can be explained in part by methodological limitations in some studies (lack of sensitivity tests, experimental design). 2) psycho-order factors and fatigue are also an explanatory variable in the sense that literature data often show that cognitive complaints are correlated with levels of anxiety and depression and fatigue. 3) Finally, metacognition, often assessed in neurodegenerative diseases or even in normal aging to better understand its impact on cognitive disorders, including memory impairment, and the complaint has never been explored in patients with cancer.
Metacognition is a complex but highly sensitive to measure and understand the patient's complaint and correspondence or disagree with the actual performance concept. Metacognition refers A) metacognitive knowledge, ie knowledge of an individual's own cognitive processes; This is a non-dependent activity during which, upstream of the performance of any task, implement an appropriate strategy, anticipate and plan cognitive steps that would be necessary for its success general knowledge; and B) metacognitive experiences, ie knowledge that is based on a cognitive activity in progress, which allows to monitor and control the task in order to maintain or otherwise modify the cognitive processes involved.
While metacognitive knowledge (A) are assessed by multiple choice questionnaires, metacognitive experiences (B) allow targeted and precise fine measures of correspondence between the prediction performance by the patient himself and his actual performance a mnemonic task (for JOL and FOK Judgment of Learning for Feeling Of Knowing). Studies exploring the effects of age on metamemory usually show a deficit of these metacognitive experiences in normal aging compared to young subjects.
Collected at the time of learning, JOL is a prediction of future performance for information that have just been learned. More specifically, when learning words, the subject must judge its ability to further free recall for each item (quantitative data). This prediction is then compared to the actual memory performance found in the free recall task. This comparison allows to judge the accuracy of the prediction and therefore the accuracy of metamemory judgment.
The FOK corresponds to a prediction of performance information that could not be provided in free recall recognition. In practice, when an item is not recovered in free recall, the subject must judge its ability to recognize the correct answer among distractor responses.
Metacognitive processes can refer to the field of memory (metamemory) or attention (métaattention), but for now metamemory was much valued neuropsychological tests and the testing and are most successful and many more.
- Conditions
- Metamemory, Memory Complaints, Performance Mnemonic, Cancer
- Being tested
- behavioral assessments
- Keywords
- metamemory, memory complaints, performance mnemonic, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral assessmentsOther
Neuropsychological evaluation, psychopathological assessment and fatigue
| Study group | Role | What they receive |
|---|---|---|
| Patient | Neuropsychological evaluation, psychopathological assessment and fatigue Receives: Other: behavioral assessments | |
| Control group | Neuropsychological evaluation, psychopathological assessment and fatigue Receives: Other: behavioral assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of metamemory through questionnaires
Comparison with questionnaires completed by healthy subjects matched controls.
Measured: At study entry
Secondary outcomes (1)
Influence of anxiety and depression and fatigue factors on metamemory.
Search by questionnaires the influence of anxiety and depression and fatigue factors on metamemory.
Measured: At study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startApr 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetamemoryStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence JOLY, PhD, Principal investigator, Centre François Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212132
- Sponsor's protocol ID
- METACAN
- Status last verified
- Aug 2015
- First submitted
- 4 Aug 2014
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relations Between Cognitive Complaints and Cognitive Scores Goals in Cancer: Assessment of Metamemory
- ClinicalTrials.gov ID
- NCT02212132
- Acronym / sponsor ID
- METACAN
- Conditions
- Metamemory, Memory Complaints, Performance Mnemonic, Cancer
- Keywords
- metamemory, memory complaints, performance mnemonic, cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 8 Aug 2014 (estimated)
- 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.
This pilot study is, in this new and original approach in cancer pathology, measure and explain the correspondence between perceived cognitive impairment (cognitive complaint) by cancer patients and their cognitive scores goals with tasks metamemory while controlling the anxiety and depression and fatigue factors of patients.
Detailed description
The relationship between performance from neuropsychological tests and subjective complaints of cancer patients treated with chemotherapy or adjuvant hormone therapy is not clear, many studies have reported no significant correlation between these two measures: the perception of patients' their cognitive deficits is generally increased relative to that which is measured by neuropsychological testing.
The reason for this lack of association found is probably multifactorial. 1) It can be explained in part by methodological limitations in some studies (lack of sensitivity tests, experimental design). 2) psycho-order factors and fatigue are also an explanatory variable in the sense that literature data often show that cognitive complaints are correlated with levels of anxiety and depression and fatigue. 3) Finally, metacognition, often assessed in neurodegenerative diseases or even in normal aging to better understand its impact on cognitive disorders, including memory impairment, and the complaint has never been explored in patients with cancer.
Metacognition is a complex but highly sensitive to measure and understand the patient's complaint and correspondence or disagree with the actual performance concept. Metacognition refers A) metacognitive knowledge, ie knowledge of an individual's own cognitive processes; This is a non-dependent activity during which, upstream of the performance of any task, implement an appropriate strategy, anticipate and plan cognitive steps that would be necessary for its success general knowledge; and B) metacognitive experiences, ie knowledge that is based on a cognitive activity in progress, which allows to monitor and control the task in order to maintain or otherwise modify the cognitive processes involved.
While metacognitive knowledge (A) are assessed by multiple choice questionnaires, metacognitive experiences (B) allow targeted and precise fine measures of correspondence between the prediction performance by the patient himself and his actual performance a mnemonic task (for JOL and FOK Judgment of Learning for Feeling Of Knowing). Studies exploring the effects of age on metamemory usually show a deficit of these metacognitive experiences in normal aging compared to young subjects.
Collected at the time of learning, JOL is a prediction of future performance for information that have just been learned. More specifically, when learning words, the subject must judge its ability to further free recall for each item (quantitative data). This prediction is then compared to the actual memory performance found in the free recall task. This comparison allows to judge the accuracy of the prediction and therefore the accuracy of metamemory judgment.
The FOK corresponds to a prediction of performance information that could not be provided in free recall recognition. In practice, when an item is not recovered in free recall, the subject must judge its ability to recognize the correct answer among distractor responses.
Metacognitive processes can refer to the field of memory (metamemory) or attention (métaattention), but for now metamemory was much valued neuropsychological tests and the testing and are most successful and many more.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: behavioral assessmentsNeuropsychological evaluation, psychopathological assessment and fatigue |
| Control group | – | Other: behavioral assessmentsNeuropsychological evaluation, psychopathological assessment and fatigue |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient being treated for a solid tumor or hematological
Key inclusion criteria (7 listed)
- Patient being treated for a solid or hematologic malignancy;
- Patients under 65 years of age;
- Patients Grade 3 'end primary school "minimum (scale Barbizet);
- Primary cancer of the central nervous system or brain metastases Absence;
- No major cognitive disorders;
Key exclusion criteria (6 listed)
- Patients with paraneoplastic syndrome;
- Scalable psychiatric pathology;
- Refusal to participate;
- Patients unable to meet the cognitive tests;
- Use of drugs;
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 |
|---|---|---|
| behavioral assessmentsNeuropsychological evaluation, psychopathological assessment and fatigue | Other | Control group, Patient |
Primary outcome
Evaluation of metamemory through questionnaires
Time frame: At study entry
Comparison with questionnaires completed by healthy subjects matched controls.
1 secondary outcome
Influence of anxiety and depression and fatigue factors on metamemory.
Time frame: At study entry
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 6 Aug 2015.
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.
Florence JOLY, PhD principal investigator
Centre François Baclesse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metamemory and Memory Complaints, run by Centre Francois Baclesse at 1 site 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 7 inclusion and 6 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 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Evaluation of metamemory through questionnaires (time frame: At study entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2015.