Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT04469205
Status:
TERMINATED
Last Update Posted:
2024-04-09
First Post:
2020-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Assess the Impact of Personalized Coaching on the Time Period and Quality of Return to Work After Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'whyStopped': 'insufficient recruiting', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-05', 'studyFirstSubmitDate': '2020-06-08', 'studyFirstSubmitQcDate': '2020-07-10', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of coaching sessions on the return to work rate (number of patients returning at work / total number of patients per arm) 6 months after inclusion in the study', 'timeFrame': '6 months', 'description': 'The rate of patients returning to work (part-time or full-time) for more than 2 weeks to 6 months of inclusion in the study in each group.'}], 'secondaryOutcomes': [{'measure': 'Quality of the return to work', 'timeFrame': '6 and 12 months', 'description': 'Evaluation of the quality of the return to work at 6 and 12 months after inclusion by questionnaire VOW / QFT (in case of return to work only).\n\nEvaluation scale : 1=never to 4=ever'}, {'measure': 'Sustainability of the return to work', 'timeFrame': '6 and 12 months', 'description': 'Evaluation of the durability of the return to work at 6 and 12 months after inclusion by registration by the patients of the number of days off work and / or working time arrangement'}, {'measure': 'Impact of the return to work / work stoppage on the quality of life', 'timeFrame': '6 and 12 months', 'description': 'Evaluation of the impact of return to work / work stoppage on the quality of life estimated by QLQ-C30 questionnaire at baseline and at 6 and 12 months post-inclusion'}, {'measure': 'The production losses related to presenteeism during maintenance or return to work', 'timeFrame': '6 and 12 months', 'description': 'Evaluation of production losses related to presenteeism at the time of maintenance or return to work at 6 and 12 months post inclusion, by collecting the number of days worked during the study period (12 months)'}, {'measure': 'The production losses related to presenteeism during maintenance or return to work', 'timeFrame': '6 and 12 months', 'description': 'Evaluation of the loss of productivity during a professional activity : in case of return to work, the "Work limitation questionnaire" will be completed at 6 and 12 months after inclusion'}, {'measure': 'The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)', 'timeFrame': '12 months', 'description': 'Determining the determinants of return to work at 6 and 12 months post inclusion using the QLQ-BR23questionnaire.\n\nEvaluation scale : 0=not at all to 4=a lot'}, {'measure': 'The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)', 'timeFrame': '6 and 12 months', 'description': 'Determining the determinants of return to work at 6 and 12 months post inclusion using the QLQ-FA12 questionnaire.\n\nEvaluation scale : 0=not at all to 4=a lot'}, {'measure': 'The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)', 'timeFrame': '6 and 12 months', 'description': 'Determining the determinants of return to work at 6 and 12 months post inclusion using the HADS questionnaire.\n\nAnxiety scale : 3=most of the time to 0=never Depression scale : 3=never to 0= most of the time'}, {'measure': 'The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)', 'timeFrame': '6 and 12 months', 'description': 'Determining the determinants of return to work at 6 and 12 months post inclusion using the SSQ6 questionnaire.\n\nEvaluation scale : 1=really dissatisfied to 6 =really satisfied'}, {'measure': 'The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)', 'timeFrame': '6 and 12 months', 'description': 'Determining the determinants of return to work at 6 and 12 months post inclusion using the Brief Cope questionnaire.\n\nEvaluation scale : 0=not at all to 4=absolutely'}, {'measure': 'The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)', 'timeFrame': '6 and 12 months', 'description': 'These determinants will also be evaluated through the collection of socio-demographic data, cancer characteristics and treatments administered.'}, {'measure': 'The medico-economic impact of returning to work', 'timeFrame': '12 months', 'description': 'Evaluation of the medico-economic impact of return to work by comparing the costs of care in the two groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Surgery']}, 'descriptionModule': {'briefSummary': 'Evaluate the impact of coaching sessions on the return to work rate (number of patients returning at work / total number of patients per arm) 6 months after inclusion in the study for breast cancer in professionnally active patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAny patient active at the time of the diagnosis of breast cancer, treated consecutively at the Institut Curie during the study period, and whose first treatment will be surgery, will be offered participation in the study.\n\n1. Invasive non-metastatic breast cancer, treated first by surgery\n2. Age ≥ 18 and ≤ 60 years\n3. Active woman at the time of diagnosis\n4. Patient with internet access and email address\n5. Patient affiliated with a social security scheme, speaking and reading French\n6. Signature of informed consent\n\nExclusion Criteria:\n\n1. In situ breast cancer\n2. History of breast cancer\n3. Metastatic breast cancer\n4. Inflammatory Breast Cancer\n5. Woman with a life expectancy \\<6 months at the time of diagnosis (in relation to other serious chronic diseases)\n6. Persons deprived of liberty or under guardianship\n7. Impossibility to submit to the medical follow-up of the test for geographical, social or psychological reasons'}, 'identificationModule': {'nctId': 'NCT04469205', 'acronym': 'OPTICOACH', 'briefTitle': 'Study to Assess the Impact of Personalized Coaching on the Time Period and Quality of Return to Work After Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Institut Curie'}, 'officialTitle': 'Randomized and Prospective Study to Assess the Impact of Personalized Coaching on the Time Period and Quality of Return to Work After Breast Cancer', 'orgStudyIdInfo': {'id': 'IC 2017-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'intervention group that will receive return-to-work coaching sessions. The intervention consists of 3 individual coaching sessions with a certified professional coach. This personalized accompaniment will complete the standard accompaniment offered to all patients.', 'interventionNames': ['Other: Coaching sessions']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': "control group who will receive the current care which consists of a psychosocial care.\n\nThis care consists in offering the patient regular information meetings organized with social workers of the Health Insurance, to consult a psychologist and to access patients' homes at the frequency of their choice and according to their need."}], 'interventions': [{'name': 'Coaching sessions', 'type': 'OTHER', 'description': 'There are 3 sessions : the first session will last 1h30 and will be in consultation within the Institut Curie. The second session will last 1h30 and will be done remotely (by phone or by videoconference). The duration of the 3rd and last session will be adapted according to the needs of each patient and will last a maximum of 1 hour. It will also be done remotely (by phone or by videoconference).', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75005', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '92210', 'city': 'Saint-Cloud', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.', 'ipdSharing': 'YES', 'description': 'Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.', 'accessCriteria': 'Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Curie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}