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

C

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)

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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