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

Breast Cancer Clinical Trial

— PROSOM-K  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03420105
• Other study ID #: PROSOM-K
• Status: Completed
• Phase: N/A
• Start date: January 5, 2018
• Est. completion date: March 6, 2020

Study information

• Verified date: February 2020
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 6, 2020
• Est. primary completion date: March 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Memory Disorders

Intervention

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

Drug:
• Hormonotherapy
Adjuvant hormone therapy

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen
France	Inserm-Ephe-Unicaen U1077 (	Caen

Sponsors (2)

Lead Sponsor	Collaborator
Centre Francois Baclesse	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The memory components and memory loss mechanisms by questionnaires		6 months after the end of radiotherapy
Secondary	The effect of sleep quality on the recovery of intentions in prospective memory by questionnaires		6 months after the end of radiotherapy
Secondary	The impact of adjuvant hormone therapy on the functioning of prospective memory by questionnaires		6 months after the end of radiotherapy
Secondary	The influence of anxio-depressive factors and fatigue on prospective memory by questionnaires		6 months after the end of radiotherapy