Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT03420105
Status:
COMPLETED
Last Update Posted:
2020-03-09
First Post:
2018-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D008569', 'term': 'Memory Disorders'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '50 patients including:\n\n* 25 patients being treated with adjuvant hormone therapy (Group A)\n* 25 patients not receiving adjuvant hormone therapy (Group B)\n* 25 healthy volunteers'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-06', 'studyFirstSubmitDate': '2018-01-10', 'studyFirstSubmitQcDate': '2018-02-01', 'lastUpdatePostDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The memory components and memory loss mechanisms by questionnaires', 'timeFrame': '6 months after the end of radiotherapy'}], 'secondaryOutcomes': [{'measure': 'The effect of sleep quality on the recovery of intentions in prospective memory by questionnaires', 'timeFrame': '6 months after the end of radiotherapy'}, {'measure': 'The impact of adjuvant hormone therapy on the functioning of prospective memory by questionnaires', 'timeFrame': '6 months after the end of radiotherapy'}, {'measure': 'The influence of anxio-depressive factors and fatigue on prospective memory by questionnaires', 'timeFrame': '6 months after the end of radiotherapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Memory Disorders']}, 'referencesModule': {'references': [{'pmid': '41309988', 'type': 'DERIVED', 'citation': 'Elia C, Perrier J, Duivon M, Rehel S, Gernier F, Fernette M, Doidy F, Clochon P, Grellard JM, Christy F, Segura-Djezzar C, Geffrelot J, Emile G, Allouache D, Viader F, Levy C, Joly F, Eustache F, Giffard B. Links between nocturnal hypoxia and cognitive function in breast cancer. Sci Rep. 2025 Nov 27;15(1):42405. doi: 10.1038/s41598-025-26591-z.'}, {'pmid': '30176833', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major patients under the age of 70;\n* Patients who have been treated by surgery or radiotherapy for non-metastatic breast cancer\n* Radiotherapy completed for about 6 months\n* Level of study 3 "end of primary studies" minimum (Barbizet scale);\n* French mother tongue;\n* Menopausal women for at least 1 year before the selection visit\n* Absence of primary cancer of the central nervous system or brain metastases;\n* Absence of previous neurological damage;\n* Absence of personality disorders and progressive psychiatric pathology;\n* Having signed the informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Primary cancer other than breast\n* Metastatic cancer\n* Treated by chemotherapy\n* Cognitive function disorders pre-existing to cancer diagnosis\n* Patients with paraneoplastic syndrome;\n* Evolutionary psychiatric pathology;\n* Refusal of participation;\n* Patients unable to respond to cognitive tests;\n* Drug use or excessive consumption of alcohol.'}, 'identificationModule': {'nctId': 'NCT03420105', 'acronym': 'PROSOM-K', 'briefTitle': 'Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep', 'organization': {'class': 'OTHER', 'fullName': 'Centre Francois Baclesse'}, 'officialTitle': 'Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep', 'orgStudyIdInfo': {'id': 'PROSOM-K'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group A', 'description': 'Patients perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests', 'interventionNames': ['Other: Neuropsychological, psycho-pathological and quality of life assessments', 'Drug: Hormonotherapy']}, {'type': 'OTHER', 'label': 'Group B', 'description': 'Patients perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests', 'interventionNames': ['Other: Neuropsychological, psycho-pathological and quality of life assessments']}, {'type': 'OTHER', 'label': 'Healthy volunteers', 'description': 'Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests', 'interventionNames': ['Other: Neuropsychological, psycho-pathological and quality of life assessments']}], 'interventions': [{'name': 'Neuropsychological, psycho-pathological and quality of life assessments', 'type': 'OTHER', 'otherNames': ['sleep tests'], 'description': 'Patients and Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests', 'armGroupLabels': ['Group A', 'Group B', 'Healthy volunteers']}, {'name': 'Hormonotherapy', 'type': 'DRUG', 'description': 'Adjuvant hormone therapy', 'armGroupLabels': ['Group A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14076', 'city': 'Caen', 'country': 'France', 'facility': 'Centre François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Caen', 'country': 'France', 'facility': 'Inserm-Ephe-Unicaen U1077 (', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Francois Baclesse', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}