Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep (PROSOM-K)
Primary Purpose
Breast Cancer, Memory Disorders
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuropsychological, psycho-pathological and quality of life assessments
Hormonotherapy
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer
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.
Sites / Locations
- Centre François Baclesse
- Inserm-Ephe-Unicaen U1077 (
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Group A
Group B
Healthy volunteers
Arm Description
Patients perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests
Patients perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests
Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests
Outcomes
Primary Outcome Measures
The memory components and memory loss mechanisms by questionnaires
Secondary Outcome Measures
The effect of sleep quality on the recovery of intentions in prospective memory by questionnaires
The impact of adjuvant hormone therapy on the functioning of prospective memory by questionnaires
The influence of anxio-depressive factors and fatigue on prospective memory by questionnaires
Full Information
NCT ID
NCT03420105
First Posted
January 10, 2018
Last Updated
March 6, 2020
Sponsor
Centre Francois Baclesse
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT03420105
Brief Title
Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep
Acronym
PROSOM-K
Official Title
Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 5, 2018 (Actual)
Primary Completion Date
March 6, 2020 (Actual)
Study Completion Date
March 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Memory Disorders
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Other
Arm Description
Patients perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests
Arm Title
Group B
Arm Type
Other
Arm Description
Patients perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests
Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests
Intervention Type
Other
Intervention Name(s)
Neuropsychological, psycho-pathological and quality of life assessments
Other Intervention Name(s)
sleep tests
Intervention Description
Patients and Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests
Intervention Type
Drug
Intervention Name(s)
Hormonotherapy
Intervention Description
Adjuvant hormone therapy
Primary Outcome Measure Information:
Title
The memory components and memory loss mechanisms by questionnaires
Time Frame
6 months after the end of radiotherapy
Secondary Outcome Measure Information:
Title
The effect of sleep quality on the recovery of intentions in prospective memory by questionnaires
Time Frame
6 months after the end of radiotherapy
Title
The impact of adjuvant hormone therapy on the functioning of prospective memory by questionnaires
Time Frame
6 months after the end of radiotherapy
Title
The influence of anxio-depressive factors and fatigue on prospective memory by questionnaires
Time Frame
6 months after the end of radiotherapy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Inserm-Ephe-Unicaen U1077 (
City
Caen
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30176833
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.
Results Reference
derived
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Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep
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