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Clinical Trials/NCT03420105
NCT03420105
Completed
Not Applicable

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

Centre Francois Baclesse2 sites in 1 country75 target enrollmentJanuary 5, 2018

Overview

Phase
Not Applicable
Intervention
Neuropsychological, psycho-pathological and quality of life assessments
Conditions
Breast Cancer
Sponsor
Centre Francois Baclesse
Enrollment
75
Locations
2
Primary Endpoint
The memory components and memory loss mechanisms by questionnaires
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 5, 2018
End Date
March 6, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Centre Francois Baclesse
Responsible Party
Sponsor

Eligibility Criteria

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.

Arms & Interventions

Group A

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

Intervention: Neuropsychological, psycho-pathological and quality of life assessments

Group A

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

Intervention: Hormonotherapy

Group B

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

Intervention: Neuropsychological, psycho-pathological and quality of life assessments

Healthy volunteers

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

Intervention: Neuropsychological, psycho-pathological and quality of life assessments

Outcomes

Primary Outcomes

The memory components and memory loss mechanisms by questionnaires

Time Frame: 6 months after the end of radiotherapy

Secondary Outcomes

  • 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)

Study Sites (2)

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