Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2026-01-03 @ 8:24 PM
Study NCT ID:
NCT03743961
Status:
TERMINATED
Last Update Posted:
2020-07-07
First Post:
2018-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Geriatric Intervention Contribution on Quality of Life of Elderly Patients With Metastatic Neoplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Low rythm of inclusions', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-03', 'studyFirstSubmitDate': '2018-10-08', 'studyFirstSubmitQcDate': '2018-11-15', 'lastUpdatePostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of quality of life', 'timeFrame': '6 months', 'description': 'Level of quality of life will be measured with the QoL ELD 14 (Quality Qf Life ELDerly patients with 14 Questions)'}, {'measure': 'Level of quality of life', 'timeFrame': '6 months', 'description': 'Level of quality of life will be measured with the QoL Q30 (Quality Qf Life with 30 Questions)'}], 'secondaryOutcomes': [{'measure': 'number of hospitalizations', 'timeFrame': '6 months', 'description': 'number of hospitalizations will be reported'}, {'measure': 'Duration of hospitalizations', 'timeFrame': '6 months', 'description': 'Duration of hospitalizations will be reported in hours'}, {'measure': 'Number of toxicities ( grade 3 and 4)', 'timeFrame': '6 months', 'description': 'Number of toxicities (grade 3 and 4) will be reported according to the CTCAE v4.0 (Common Terminology Criteria for Adverse Events)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['quality of life', 'elderly', 'metastatic neoplasia', 'systemic therapies'], 'conditions': ['Systemic Treatment', 'Metastatic Neoplasia', 'Elderly Patients']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to describe the impact of : Geriatric intervention contribution on quality of life of elderly patients receiving systemic treatments for metastatic neoplasia', 'detailedDescription': 'Elderly cancer incidence increases exponentially with advancing age. However, elderly patients are largely underrepresented in cancer treatment trials. The geriatric population presents particular physical, mental, psychological or social specificities that may condition the prognosis especially for patients with metastatic neoplasia. Recently, the measurement of quality of life (QoL) in aging population is being recognized as an important part of clinical decision. It is therefore essential to set up prospective studies to evaluate the impact of oncogeriatric practices on the quality of life of elderly patients with metastatic neoplasia. The main objective of this prospective study is to describe the contribution of geriatric intervention on quality of life for for elderly (\\> 75 years) with metastatic solid cancer receiving systemic treatment during the first 6 months of their therapeutic management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with minimum 75 years old will perform two questionnaires about quality of life and then, according to these scores they will perform a geriatric intervention.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with solid metastatic neoplasia\n* 75 years old or more\n* Men or women\n* ECOG between 0 and 3\n* Patient receiving systemic antineoplasic treatment (chemotherapy, hormonotherapy, immunotherapy, targeted therapy)\n\nExclusion Criteria:\n\n* ECOG 4\n* Localized cancer\n* Patients already included in a study witch could modify quality of life\n* Patient unable to give their consent'}, 'identificationModule': {'nctId': 'NCT03743961', 'acronym': 'QUALI', 'briefTitle': 'Geriatric Intervention Contribution on Quality of Life of Elderly Patients With Metastatic Neoplasia', 'organization': {'class': 'OTHER', 'fullName': 'Institut de Cancérologie de la Loire'}, 'officialTitle': 'Description the Geriatric Intervention Contribution on Quality of Life of Elderly Patients With Metastatic Neoplasia : Prospective Descriptive Non-comparative Cohort ( QUALI Cohort)', 'orgStudyIdInfo': {'id': '2018-0801'}, 'secondaryIdInfos': [{'id': '2018-A02315-50', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A : control group', 'description': 'Evaluation of quality of life with the EORTC QoL ELD 14 (Quality Qf Life ELDerly patients with 14 Questions) and QoL EORTC Q30 (Quality Qf Life with 30 Questions)\n\nfor patients with G8 score \\> 14/17'}, {'label': 'Group B : geriatric intervention group', 'description': 'Evaluation of quality of life with the EORTC QoL ELD 14 (Quality Qf Life ELDerly patients) and QoL (Quality Qf Life) EORTC Q30 for patients with G8 score ≤14/17 ( in this arm there is two groups : patient who received geriatric intervention before treatment initiation (group A) and group of patient did not received geriatric intervention before treatment initiation( group B))', 'interventionNames': ['Other: geriatric intervention']}], 'interventions': [{'name': 'geriatric intervention', 'type': 'OTHER', 'description': 'Geriatric intervention', 'armGroupLabels': ['Group B : geriatric intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42270', 'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'Institut de Cancérologie Lucien Neuwirth', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}], 'overallOfficials': [{'name': 'Blandine De Lavigerie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de Cancérologie Lucien Neuwirth'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Cancérologie de la Loire', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}