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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02212132
Other study ID # METACAN
Secondary ID
Status Completed
Phase N/A
First received August 4, 2014
Last updated August 5, 2015
Start date April 2013
Est. completion date August 2015

Study information

Verified date August 2015
Source Centre Francois Baclesse
Contact n/a
Is FDA regulated No
Health authority France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Study type Observational

Clinical 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 patients.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Patients with paraneoplastic syndrome;

- Scalable psychiatric pathology;

- Refusal to participate;

- Patients unable to meet the cognitive tests;

- Use of drugs;

- Heavy drinking.

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
behavioral assessments
Neuropsychological evaluation, psychopathological assessment and fatigue

Locations

Country Name City State
France Centre François Baclesse Caen

Sponsors (1)

Lead Sponsor Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of metamemory through questionnaires Comparison with questionnaires completed by healthy subjects matched controls. At study entry No
Secondary Influence of anxiety and depression and fatigue factors on metamemory. Search by questionnaires the influence of anxiety and depression and fatigue factors on metamemory. At study entry No
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