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

Not Applicable

Completed

• Conditions: Memory Disorders; Breast Cancer
• Interventions: Other: Neuropsychological, psycho-pathological and quality of life assessments; Drug: Hormonotherapy

• Registration Number: NCT03420105
• Lead Sponsor: Centre Francois Baclesse

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-05
• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-02-01
• Study First Posted: 2018-02-05
• Status Verified: 2020-02
• Primary Completion: 2020-03-06
• Study Completion: 2020-03-06
• Last Update Submitted: 2020-03-06
• Last Update Posted: 2020-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Hormonotherapy	Patients perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests
Group B	Neuropsychological, psycho-pathological and quality of life assessments	Patients perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests
Group A	Neuropsychological, psycho-pathological and quality of life assessments	Patients perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests
Healthy volunteers	Neuropsychological, psycho-pathological and quality of life assessments	Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests

Primary Outcome Measures

Name	Time	Method
The memory components and memory loss mechanisms by questionnaires	6 months after the end of radiotherapy

Secondary Outcome Measures

Name	Time	Method
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
The effect of sleep quality on the recovery of intentions in prospective memory by questionnaires	6 months after the end of radiotherapy

Trial Locations

Locations (2)

Inserm-Ephe-Unicaen U1077 (; 🇫🇷 Caen, France

Centre François Baclesse; 🇫🇷 Caen, France