CompletedNCT03420105PROSOM-KUpdated Mar 9, 2020

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

An interventional study of Neuropsychological, psycho-pathological and quality of life assessments and Hormonotherapy in Breast Cancer and Memory Disorders, sponsored by Centre Francois Baclesse. Completed at 2 sites in France. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-09.

Sponsored by Centre Francois Baclesse · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 75
Allocation: Non-randomized
Ages: 18 Years to 70 Years
Sex: Female

Study 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.

Conditions studied

Breast Cancer
Memory Disorders

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Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: Female
Accepts 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

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.

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 75 participants (actual)

Study arms

Other
Group A
Patients perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests
Other: Neuropsychological, psycho-pathological and quality of life assessments · Drug: Hormonotherapy
Other
Group B
Patients perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests
Other: Neuropsychological, psycho-pathological and quality of life assessments
Other
Healthy volunteers
Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests
Other: Neuropsychological, psycho-pathological and quality of life assessments

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
Also known as: sleep tests
DrugHormonotherapy
Adjuvant hormone therapy

What researchers measure

Primary outcomes

The memory components and memory loss mechanisms by questionnaires
Time frame: 6 months after the end of radiotherapy

Secondary outcomes

The effect of sleep quality on the recovery of intentions in prospective memory by questionnaires
Time frame: 6 months after the end of radiotherapy
The impact of adjuvant hormone therapy on the functioning of prospective memory by questionnaires
Time frame: 6 months after the end of radiotherapy
The influence of anxio-depressive factors and fatigue on prospective memory by questionnaires
Time frame: 6 months after the end of radiotherapy

Study locations

2 sites

Centre François Baclesse
Caen, 14076, France
Inserm-Ephe-Unicaen U1077 (
Caen, France

References and documents

Publications

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. PubMed 30176833 ↗

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03420105
Lead sponsor: Centre Francois Baclesse
Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
Responsible party: Sponsor
First posted: Feb 5, 2018
Start date: Jan 5, 2018
Primary completion: Mar 6, 2020
Completion: Mar 6, 2020
Last update: Mar 9, 2020

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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