Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-02-25 @ 9:48 PM
Study NCT ID:
NCT04802902
Status:
COMPLETED
Last Update Posted:
2024-02-26
First Post:
2021-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Immunotherapy Plus Chemotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}], 'ancestors': [{'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-23', 'studyFirstSubmitDate': '2021-03-15', 'studyFirstSubmitQcDate': '2021-03-15', 'lastUpdatePostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of home-based immunotherapy (percentage of patients who interrupted their home hospitalization for reasons directly linked to that management)', 'timeFrame': '1 year', 'description': 'Feasibility under good conditions of home-based immunotherapy, defined by the percentage of patients who interrupted their home hospitalization for reasons directly linked to that management.'}], 'secondaryOutcomes': [{'measure': 'Cost-benefit analysis', 'timeFrame': '1 year', 'description': 'A cost-benefit analysis comparing hospital-at-home programme and classical day hospitalization'}, {'measure': 'Number of adverse effects occuring during the study', 'timeFrame': '1 year', 'description': 'Immunotherapy related adverse effects monitoring criteria evaluation'}, {'measure': 'Number of Incidents occurring during the Hospital at Home program handling process', 'timeFrame': '1 year', 'description': 'The occurrence of possible incidents related to the Hospital at Home program will be collected at each home based hospitalization.'}, {'measure': 'Quality of Life Questionnaire (EORTC QLQ-C30) total score', 'timeFrame': 'at inclusion, month 3, 6 9 and 12', 'description': "To study the patient's reported quality of life before and throughout therapy. Quality of life score obtained through self-administered EORCT QLQ-C30 questionnaire at inclusion, month 3, 6 9 and 12."}, {'measure': "Patients' Satisfaction Questionnaire", 'timeFrame': 'at month 3, 6 9 and 12', 'description': "Patients' satisfaction with their home base management will be assessed with a questionnaire. It will be collected at month 3, 6 9 and 12"}, {'measure': 'Healthcare professional satisfaction', 'timeFrame': 'at month 6, 12, 18 and 24 of the study', 'description': 'Healthcare professional satisfaction will be assessed with a questionnaire. It will be collected at month 6, 12, 18 and 24 of the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['immunotherapy', 'chimiotherapy', 'Bronchial cancer', 'home-based hospitalization'], 'conditions': ['Bronchial Cancer']}, 'descriptionModule': {'briefSummary': "This observational prospective monosite study aims to describe, for the first time, management in a hospital-at-home programme of patients treated by immunotherapy-chemotherapy combo for bronchial cancer in maintenance phase of first row metastatic treatment.\n\nThe feasibility in good conditions of this management, the patients' quality of life and their satisfaction will be evaluated. A cost-benefit analysis will be done to compare hospital-at-home programme and classical day hospitalization.", 'detailedDescription': "Those last years, immunotherapy treatment for bronchial cancers allowed considerable progress in terms of tumoral answer, survival without progression and global survival. Usually administered in the day hospitalization department, its preparation and administration to the patient are compatible with hospital-at-home management. This type of management has particularly developed in the context of the COVID pandemic and recommendations for good practices in hospital-at-home immunotherapy have recently been drafted by FITC (Société Française d'Immuno-Thérapie du Cancer). These recommendations open the way for administration of immunotherapy and chemotherapy combo in hospital-at-home. At the moment, there is no study stating the feasibility of home hospitalization for patients treated by immunotherapy-chemotherapy combo. To follow up on the feasibility study of home immunotherapy (ImHADom) carried out at CH Pau from March 2019 to March 2021, the sponsor propose to evaluate with descriptive study the feasibility under the same conditions of chemotherapy-immunotherapy in patients treated in the maintenance phase of a first metastatic row.\n\nThis study will be proposed to all the patients in maintenance phase of first row treatment with at least one positive tumoral imaging assessment (stable disease or partial response) for whom home hospitalization has been decided and scheduled by the healthcare team in a medical staff meeting.\n\nThe patients included in the study will be followed according to the common practice: a consultation every 3 months during 1 year."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated by immunotherapy and chemotherapy combo in maintenance phase for bronchial cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 and over,\n* with bronchial metastatic cancer treated in first row maintenance phase by immunotherapy-chemotherapy combo,\n* having at least one assessments of the response to immunotherapy received in day hospitalization with efficiency (stability or partial response),\n* without any graded higher than 1 adverse effects, or uncontrolled grade 1 adverse effects related to immunotherapy\n* eligible for a home-based hospitalization\n\nExclusion Criteria:\n\n* Frail patients requiring a frequent medical assessment thus day hospitalization cares'}, 'identificationModule': {'nctId': 'NCT04802902', 'acronym': 'CombHADom', 'briefTitle': 'Feasibility of Immunotherapy Plus Chemotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de PAU'}, 'officialTitle': 'Feasibility of Immunotherapy Plus Chemotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting - CombHADom', 'orgStudyIdInfo': {'id': 'CHPAU2021/03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'home-based hospitalization', 'type': 'OTHER', 'description': 'management in a hospital-at-home programme of patients treated by immunotherapy and chimiotherapy combo for bronchial cancer'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64160', 'city': 'Pau', 'state': 'Aquitaine', 'country': 'France', 'facility': 'Centre hospitalier de pau', 'geoPoint': {'lat': 43.31117, 'lon': -0.35583}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de PAU', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}