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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-05

Study Completion Date

2020-03-06

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.

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Detailed Description

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Conditions

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Breast Cancer Memory Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group A

Patients perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests

Group Type OTHER

Neuropsychological, psycho-pathological and quality of life assessments

Intervention Type OTHER

Patients and Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests

Hormonotherapy

Intervention Type DRUG

Adjuvant hormone therapy

Group B

Patients perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests

Group Type OTHER

Neuropsychological, psycho-pathological and quality of life assessments

Intervention Type OTHER

Patients and Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests

Healthy volunteers

Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests

Group Type OTHER

Neuropsychological, psycho-pathological and quality of life assessments

Intervention Type OTHER

Patients and Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests

Interventions

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Neuropsychological, psycho-pathological and quality of life assessments

Patients and Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests

Intervention Type OTHER

Hormonotherapy

Adjuvant hormone therapy

Intervention Type DRUG

Other Intervention Names

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sleep tests

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes