Clinical trial NCT03420105: Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep
Official title: Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Memory Disorders
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2018-02-05
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 50 patients including:

* 25 patients being treated with adjuvant hormone therapy (Group A)
* 25 patients not receiving adjuvant hormone therapy (Group B)
* 25 healthy volunteers
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: The memory components and memory loss mechanisms by questionnaires
timeFrame: 6 months after the end of radiotherapy
Secondary outcomes:
measure: The effect of sleep quality on the recovery of intentions in prospective memory by questionnaires
timeFrame: 6 months after the end of radiotherapy
measure: The impact of adjuvant hormone therapy on the functioning of prospective memory by questionnaires
timeFrame: 6 months after the end of radiotherapy
measure: The influence of anxio-depressive factors and fatigue on prospective memory by questionnaires
timeFrame: 6 months after the end of radiotherapy
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
city: Caen
country: France
facility: Inserm-Ephe-Unicaen U1077 (
Study officials:
References:
citation: Duivon M, Perrier J, Joly F, Licaj I, Grellard JM, Clarisse B, Levy C, Fleury P, Madeleine S, Lefevre N, Rauchs G, Lecouvey G, Fraisse F, Viader F, Eustache F, Desgranges B, Giffard B. Impact of breast cancer on prospective memory functioning assessed by virtual reality and influence of sleep quality and hormonal therapy: PROSOM-K study. BMC Cancer. 2018 Sep 3;18(1):866. doi: 10.1186/s12885-018-4762-2.