Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep

Study Overview
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Brief Summary
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The results of this study will contribute to a better understanding of prospective memory deficit processes in breast cancer in relation to sleep disorders frequently reported in this pathology. In the long term, a better understanding will make it possible to envisage appropriate treatments to compensate for these memory difficulties and to improve the autonomy of the patients.

Official Title
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Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep

Conditions
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Breast Cancer, Memory Disorders

Intervention / Treatment
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* Other: Neuropsychological, psycho-pathological and quality of life assessments
* Drug: Hormonotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major patients under the age of 70; Patients who have been treated by surgery or radiotherapy for non-metastatic breast cancer Radiotherapy completed for about 6 months Level of study 3 end of primary studies minimum (Barbizet scale); French mother tongue; Menopausal women for at least 1 year before the selection visit Absence of primary cancer of the central nervous system or brain metastases; Absence of previous neurological damage; Absence of personality disorders and progressive psychiatric pathology; Having signed the informed consent to participate in the study. Exclusion Criteria: Primary cancer other than breast Metastatic cancer Treated by chemotherapy Cognitive function disorders pre-existing to cancer diagnosis Patients with paraneoplastic syndrome; Evolutionary psychiatric pathology; Refusal of participation; Patients unable to respond to cognitive tests; Drug use or excessive consumption of alcohol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 50 patients including: 25 patients being treated with adjuvant hormone therapy (Group A) 25 patients not receiving adjuvant hormone therapy (Group B) 25 healthy volunteers
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A<br>Patients perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests | Other: Neuropsychological, psycho-pathological and quality of life assessments<br>* Patients and Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests<br>* Other names: sleep tests;Drug: Hormonotherapy<br>* Adjuvant hormone therapy<br>|
| Other: Group B<br>Patients perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests | Other: Neuropsychological, psycho-pathological and quality of life assessments<br>* Patients and Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests<br>* Other names: sleep tests;|
| Other: Healthy volunteers<br>Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests | Other: Neuropsychological, psycho-pathological and quality of life assessments<br>* Patients and Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests<br>* Other names: sleep tests;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The memory components and memory loss mechanisms by questionnaires |  | 6 months after the end of radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of sleep quality on the recovery of intentions in prospective memory by questionnaires |  | 6 months after the end of radiotherapy | 
| The impact of adjuvant hormone therapy on the functioning of prospective memory by questionnaires |  | 6 months after the end of radiotherapy | 
| The influence of anxio-depressive factors and fatigue on prospective memory by questionnaires |  | 6 months after the end of radiotherapy |