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

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ClinicalTrials.gov Identifier: NCT03420105
Recruitment Status : Completed
First Posted : February 5, 2018
Last Update Posted : March 9, 2020
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Centre Francois Baclesse

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Memory Disorders Other: Neuropsychological, psycho-pathological and quality of life assessments Drug: Hormonotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep
Actual Study Start Date : January 5, 2018
Actual Primary Completion Date : March 6, 2020
Actual Study Completion Date : March 6, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: sleep tests

Drug: Hormonotherapy
Adjuvant hormone therapy

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 Name: sleep tests

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 Name: sleep tests




Primary Outcome Measures :
  1. The memory components and memory loss mechanisms by questionnaires [ Time Frame: 6 months after the end of radiotherapy ]

Secondary Outcome Measures :
  1. The effect of sleep quality on the recovery of intentions in prospective memory by questionnaires [ Time Frame: 6 months after the end of radiotherapy ]
  2. The impact of adjuvant hormone therapy on the functioning of prospective memory by questionnaires [ Time Frame: 6 months after the end of radiotherapy ]
  3. The influence of anxio-depressive factors and fatigue on prospective memory by questionnaires [ Time Frame: 6 months after the end of radiotherapy ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420105


Locations
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France
Centre François Baclesse
Caen, France, 14076
Inserm-Ephe-Unicaen U1077 (
Caen, France
Sponsors and Collaborators
Centre Francois Baclesse
Institut National de la Santé Et de la Recherche Médicale, France
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT03420105    
Other Study ID Numbers: PROSOM-K
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Memory Disorders
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases