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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03420105
Acronym
PROSOM-K
Enrollment
75
Registered
2018-02-05
Start date
2018-01-05
Completion date
2020-03-06
Last updated
2020-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Memory Disorders

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.

Interventions

OTHERNeuropsychological, psycho-pathological and quality of life assessments

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

Adjuvant hormone therapy

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
Centre Francois Baclesse
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

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

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
The memory components and memory loss mechanisms by questionnaires6 months after the end of radiotherapy

Secondary

MeasureTime frame
The effect of sleep quality on the recovery of intentions in prospective memory by questionnaires6 months after the end of radiotherapy
The impact of adjuvant hormone therapy on the functioning of prospective memory by questionnaires6 months after the end of radiotherapy
The influence of anxio-depressive factors and fatigue on prospective memory by questionnaires6 months after the end of radiotherapy

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026