Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep (PROSOM-K)

March 6, 2020 updated by: Centre Francois Baclesse
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Patients and Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests
Other Names:
  • sleep tests
Drug: Hormonotherapy
Adjuvant hormone therapy
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
Patients and Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests
Other Names:
  • sleep tests
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
Patients and Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests
Other Names:
  • sleep tests

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
The effect of sleep quality on the recovery of intentions in prospective memory by questionnaires
Time Frame: 6 months after the end of radiotherapy
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
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
6 months after the end of radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2018

Primary Completion (Actual)

March 6, 2020

Study Completion (Actual)

March 6, 2020

Study Registration Dates

First Submitted

January 10, 2018

First Submitted That Met QC Criteria

February 1, 2018

First Posted (Actual)

February 5, 2018

Study Record Updates

Last Update Posted (Actual)

March 9, 2020

Last Update Submitted That Met QC Criteria

March 6, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROSOM-K

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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