Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-26 @ 8:32 PM
Study NCT ID:
NCT05552066
Status:
COMPLETED
Last Update Posted:
2025-08-01
First Post:
2022-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anticipated Personalization of the Management in Day Hospital Unit Based on a Collection of the PROs Via a Digital Tool
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1st stage: the current circuit remains unchanged (with sytematic medical or nursing validation to confirm chemotherapy administration).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2022-09-07', 'studyFirstSubmitQcDate': '2022-09-20', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of stay in day hospital unit', 'timeFrame': 'Immediately after the chemotherapy', 'description': 'Assess the impact on the duration of stay of an anticipated personalization of the stay in HDJ based on a platform of analysis of the PROs collected the day before and the implementation of a short circuit'}], 'secondaryOutcomes': [{'measure': 'patient satisfaction', 'timeFrame': 'Immediately after the chemotherapy', 'description': 'Assessed by EORTC OUT-PATSAT7 ( patient satisfaction with cancer care core questionnaire).\n\nsatisfaction score between 0 (no satisfaction) and 100 (high satisfaction)'}, {'measure': 'Caregiver satisfaction', 'timeFrame': 'Month3;Month6', 'description': 'Assessed by self questionnaire'}, {'measure': 'Health related patient quality of life', 'timeFrame': 'Immediately after the chemotherapy', 'description': 'Assessed by EQ5D-5L (EuroQuol Five Dimension - Five Level Health Survey questionnaire) The scale has five subcomponents with scores from 1 (best) to 5 (worst)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PRO (Patient reported outcomes)', 'Chemotherapy', 'immunotherapy', 'satisfaction'], 'conditions': ['Solid Malignant Tumor']}, 'descriptionModule': {'briefSummary': 'The present study proposes a new organization of the Day Hospital unit with several possible pathways defined by PRO.\n\nThe organization realies on a platform composed of nurses supervised by an IPA and a doctor one day before a treatment in the day hospitalization unit admission, results of PROs collectyed through the CEM@santé application (a French health care application) are reviewed by nurses from the platform and chemotherapy delivery is confirmed.\n\nThe study is planed in 2 steps.\n\n1. st stage: the current circuit remains unchanged (with systematic medical or nursing validation to confirm chemotherapy administration. Patient satisfaction is collected at each visit to the day hospital unit for chemotherapy. 73 patients will be included in this phase.\n2. nd stage: a short circuit is set up. If no contraindications are identified by the plateform with the remote PRO collection, patients will undergo chemotherapy directly the next day (without any medical validation. Patient satisfaction is also collected at each visit to the day hospital unit for chemotherapy. 73 patients will be included in this phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than 18 years\n* Patient treated for solid malignancy\n* Patient starting a new chemotherapy or immunotherapy protocol.\n* Patient receiving one of the following intravenous antineoplastic treatments in day hospital: Nivolumab(1), Pembrolizumab(1), Folfox(2), Folfirinox(2), Xelox Carboplatin, EC chemotherapy (Epirubicin/Cyclophosphamide)\n* Affiliated and beneficiary to a social security system\n* Informed and written consent\n\nNote1: may be used in combination with tyrosine kinase inhibitors (TKIs) Note 2 :may be used in combination with bevacizumab, cetuximab or panitumumab\n\nExclusion Criteria:\n\n* Patient treated in neo-adjuvant situation for breast cancer\n* Does not have a connected device (smartphone, tablet or computer)\n* Does not have an internet connection\n* Difficulty in filling out a questionnaire\n* Protected adult or deprived of her liberty\n* Pregnant or lactating woman'}, 'identificationModule': {'nctId': 'NCT05552066', 'acronym': 'ANTICIPRO', 'briefTitle': 'Anticipated Personalization of the Management in Day Hospital Unit Based on a Collection of the PROs Via a Digital Tool', 'organization': {'class': 'OTHER', 'fullName': 'Center Eugene Marquis'}, 'officialTitle': 'Before and After Study, Evaluating the Efficiency of an Anticipated Personalization of the Management in Day Hospital Unit Based on a Collection of the PROs Via a Digital Tool', 'orgStudyIdInfo': {'id': '2022-3-29-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'front phase', 'description': 'The current circuit remains unchanged (medical or nursing validation to confirm chemotherapy administration). Patient satisfaction is collected at each visit to the day hospital unit for chemotherapy.', 'interventionNames': ['Other: Standard follow up']}, {'type': 'OTHER', 'label': 'Post Phase', 'description': 'A short circuit is set up. If no contraindications are identified by the plateform with the remote PRO collection, patients will undergo chemotherapy directly the next day (without any medical validation). Patient satisfaction is also collected at each visit to the day hospital unit for chemotherapy.', 'interventionNames': ['Other: short circuit']}], 'interventions': [{'name': 'Standard follow up', 'type': 'OTHER', 'description': 'Patients enrolled into front phase will be followed in a standard way without any additional procedure except satisfaction questionnaire', 'armGroupLabels': ['front phase']}, {'name': 'short circuit', 'type': 'OTHER', 'description': 'Patients included in the post phase will have to complete the "cem@santé" application. If no contraindications are identified by the plateform with the remote PRO collection, patients will undergo chemotherapy directly the next day (without any medical validation).', 'armGroupLabels': ['Post Phase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35042', 'city': 'Rennes', 'country': 'France', 'facility': 'Centre de lutte contre le cancer Eugène Marquis', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center Eugene Marquis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ligue contre le cancer, France', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}