Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep (PROSOM-K)

Centre Francois Baclesse

Status: Completed

Conditions: Breast Cancer; Memory Disorders

Treatments: Other: Neuropsychological, psycho-pathological and quality of life assessments; Drug: Hormonotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03420105

PROSOM-K

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Group A

Other group

Description:

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

Treatment:

Drug: Hormonotherapy

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

Group B

Other group

Description:

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

Treatment:

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

Healthy volunteers

Other group

Description:

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

Treatment:

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