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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

France1 site
  • Centre François Baclesse

    Caen, 14076

Other trials in France

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.

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 groups in NCT02212132
Study groupRoleWhat they receive
PatientNeuropsychological evaluation, psychopathological assessment and fatigue
Receives: Other: behavioral assessments
Control groupNeuropsychological 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.

  1. Evaluation of metamemory through questionnaires

    Comparison with questionnaires completed by healthy subjects matched controls.

    Measured: At study entry

Secondary outcomes (1)
  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.

  1. First posted8 Aug 2014 (estimated)
  2. Study startApr 2013
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

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)
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

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.

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