Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT06025604
Status:
UNKNOWN
Last Update Posted:
2023-09-15
First Post:
2023-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ACTIVPROSEIN : Professional Activity After Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 578}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-09-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-14', 'studyFirstSubmitDate': '2023-07-27', 'studyFirstSubmitQcDate': '2023-08-29', 'lastUpdatePostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To identify the impact of psycho social factors on delay of return to any modality of work, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)', 'timeFrame': '30 minutes', 'description': 'Assessment of delay of a any occupational activity recovery, from the diagnosis and until 24 months after treatment, and of any influenced factors by self administrated questionnaire, included standardized questionnaire for subjective variables'}], 'secondaryOutcomes': [{'measure': 'To identify the impact of psycho social factors on delay of return to full time work, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)', 'timeFrame': '30 minutes', 'description': 'Assessment of delay of full time work recovery, from the diagnosis and until 24 months after treatment, and of any influenced factors by self administrated questionnaire, included standardized questionnaire for subjective variables'}, {'measure': 'To identify the impact of psycho social factors on delay of return to part time work, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)', 'timeFrame': '30 minutes', 'description': 'Assessment of delay of part time work recovery, from the diagnosis and until 24 months after treatment, and of any influenced factors by self administrated questionnaire, included standardized questionnaire for subjective variables'}, {'measure': 'To identify the impact of psycho social factors on delay of return to occupational reclassification, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)', 'timeFrame': '30 minutes', 'description': 'Assessment of delay of occupational reclassification, from the diagnosis and until 24 months after treatment, and of any influenced factors by self administrated questionnaire, included standardized questionnaire for subjective variables'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Observational study', 'Prognostic factors', 'Questionary'], 'conditions': ['Breast Cancer Female', 'Return to Work']}, 'descriptionModule': {'briefSummary': 'Breast cancer is, in term of incidence, the first cancer among women in France and worldwide. This incidence is increasing, particularly among young women during their professional activity.\n\nThose observations raise de question of return to work of those patients, and, broadly, of the post cancer life and former activities recovery.\n\nThe objective of the study is to identify any factor influencing time from diagnosis to return to work (type of treatment, side effects, residual symptoms, medical staff support, occupational physician monitoring, individual or group supportive therapy, adapted physical activity, alternative therapeutics ..), and the main modalities of return to work (part or full time, professional redeployment).\n\nTo identify those factors, barriers or supports, would enable the implementation of concrete actions and programs, promoting return to work, and to a free disease life for those patients.\n\nThe main objective is to identify psycho social factors involved in the time from diagnosis to return to any modality of work, until 24 month after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included) Secondary objectives are to identify psycho social factors involved in the time from diagnosis to return to work, part time, full time, and redeployment, respectively, until 24 month after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)', 'detailedDescription': 'Patients being took care in Grenoble University Hospital, including Voiron site, from 2015 to 2019, for a localized breast cancer, will be identified be Cristal Link software.\n\nA questionary, including every studied variables and potential confounding factors, will be sent, by post or by e mail, to the patients. An information notice and a non opposition formulary will be joined to the questionary.\n\nPatients will be contacted by a paramedical member of the Women Cancer Center of the University Hospital, in order to explain them the objective of the study, and the modality of personal data management.\n\nThe questionary will be returned either by mail, or directly brought back to the Hospital along a medical appointment.\n\nData collection will focus on return to work delay, return to work modality (part or full time, redeployment), studied variables and potential confounding factors (demographic : marital status, number of dependent children, incomes / related to occupational activity : night work, job responsibility, occupational physician follow up / treatment consequences : OMS status, anxiety, depression, lymphoedema, articular pain, neuropathic pain / Support measures : physical activities, psychological support, alternative therapeutics, familial support, medical staff support).\n\nMedical data (tumour features : histology, extent, treatment : surgery, chemiotherapy, targeted therapy, hormonotherapy, radiotherapy) will be collected using informatic files.\n\nSubjective variables will be evaluated using standardized questionary (Anxiety : Stait Trait Anxiety Inventory / Depression : Hamilton Depression Scale / Cognition : FACT cog questionary / Support : Multidimensional Scale of Support).\n\nData process will be done in the Clinical Investigation Center of Grenoble University Hospital.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women between 18 and 60 years old, care in Grenoble University Hospital between 2015 and 2019 for a localized breast cancer, working at the time of diagnosis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient between 18 and 60 years old\n* Histologically proven localized breast cancer, of any subtype\n* Cared in Grenoble University Hospital between 2015 and 2019\n* Working at the time of diagnosis\n\nExclusion Criteria:\n\n* Retired at the end of adjuvant therapy\n* Deprived of liberty, under juridical protection, not able to give consent\n* Psychiatric conditions or addictive behavior interfering with questionary filling'}, 'identificationModule': {'nctId': 'NCT06025604', 'briefTitle': 'ACTIVPROSEIN : Professional Activity After Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Psycho Social Factors Associated to Return to Work After Breast Cancer Care : a Prognostic Study', 'orgStudyIdInfo': {'id': '38RC23.0151'}, 'secondaryIdInfos': [{'id': '2023-A01036-39', 'type': 'OTHER', 'domain': 'ID RCB'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuelle GA JACQUET', 'role': 'CONTACT', 'email': 'ejacquet1@chu-grenoble.fr', 'phone': '+33476765451'}, {'name': 'Anne Stoeckle', 'role': 'CONTACT', 'email': 'AStoeckle@chu-grenoble.fr'}, {'name': 'Emmanuelle JACQUET', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}