Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-03-06 @ 5:05 AM
Study NCT ID:
NCT02583035
Status:
COMPLETED
Last Update Posted:
2019-01-16
First Post:
2015-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telephone OncoGériatric Followed in the Management of Elderly Patients Treated for Cancer or Haematological Malignancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-15', 'studyFirstSubmitDate': '2015-09-17', 'studyFirstSubmitQcDate': '2015-10-20', 'lastUpdatePostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Memory on the Mini Mental Scale', 'timeFrame': '3 months after inclusion'}, {'measure': 'Falls on the number of falls', 'timeFrame': '3 months after inclusion'}, {'measure': 'Pain on the EVS (verbal scale) scale', 'timeFrame': '3 months after inclusion'}, {'measure': 'Autonomy on the ADL (activities of daily living) score', 'timeFrame': '3 months after inclusion'}, {'measure': 'Pain on the EN (numericale scale) scale', 'timeFrame': '3 months after inclusion'}, {'measure': 'Autonomy on the IADL (The Lawton Instrumental Activities of Daily Living Scale ) score', 'timeFrame': '3 months after inclusion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cancer', 'geriatric'], 'conditions': ['Cancer', 'Hematologic Malignancy']}, 'descriptionModule': {'briefSummary': 'There are no recommendations and few studies on the monitoring of fragile patients in the oncological treatment, both on the organizational arrangements on its interest in the prevention of functional deterioration of the patient and adaptation of the potential cancer treatment.\n\nThe oncogériatrique evaluation being time-consuming, requiring the movement of these more or less frail elderly patients, it seems difficult to envisage repeated and systematic standardized geriatric assessments during cancer treatment. Geriatric fragility can be detected by telephone. Craven et al. has already assessed the telephone follow-up by a nurse in patients treated for cancer, but with the aim to detect toxicities of cancer treatment, patients are not very old (mean age 64.8 years).\n\nExternal evaluation by the nurse coordinator of UCOG (Coordination Unit in geriatric oncology) not knowing the patients included avoids bias of subjectivity in the interrogation.\n\nHowever the telephone monitoring, with the aim to evaluate the evolution of geriatric frailty, has not been specifically studied in the elderly population treated for cancer, while taking oncology load.\n\nThe investigators wish to study the feasibility and validity of telephone follow-up which could eventually be used routinely to identify patients requiring further medical consultation oncogériatrique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 70 years and older with cancer or hematologic malignancies;\n* Faced benefit from cancer treatment (systemic treatment, curative radiotherapy) in one of the clinical sites;\n* Addressed in onco-gériatric consultation in the usual routine care sector;\n* Mastery of the French language;\n* Patient affiliated to the social security system;\n* Patient has given its written consent.\n\nExclusion Criteria:\n\n* Life expectancy \\<3 months\n* Inability to communicate by telephone (deafness, speech disorder, ..)\n* Inability collection of written consent\n* Group 4 SiO (International Society of Geriatric Oncology), Performance status (PS) 4\n* initial MMSE (Mini-Mental State Examination) \\<18/30\n* oncological treatment envisaged: analgesic radiotherapy or exclusive decompressive, brain radiation therapy in toto\n* Patient under guardianship'}, 'identificationModule': {'nctId': 'NCT02583035', 'acronym': 'TelOG', 'briefTitle': 'Telephone OncoGériatric Followed in the Management of Elderly Patients Treated for Cancer or Haematological Malignancy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Francois Baclesse'}, 'officialTitle': 'Telephone OncoGériatric Followed in the Management of Elderly Patients Treated for Cancer or Haematological Malignancy', 'orgStudyIdInfo': {'id': 'TelOG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Nurse telephone contact', 'description': '3 days of consultation, telephone follow-up of the patient by the nurse coordinator of the Geriatric Oncology Unit to validate', 'interventionNames': ['Other: Nurse telephone contact']}], 'interventions': [{'name': 'Nurse telephone contact', 'type': 'OTHER', 'description': 'Nurse will contact patient 3 days before consultation', 'armGroupLabels': ['Nurse telephone contact']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bayeux', 'country': 'France', 'facility': 'Centre Hospitalier', 'geoPoint': {'lat': 49.27732, 'lon': -0.7039}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '14400', 'city': 'Caen', 'country': 'France', 'facility': 'Centre François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Dieppe', 'country': 'France', 'facility': 'Centre Hospitalier', 'geoPoint': {'lat': 49.9216, 'lon': 1.07772}}, {'city': 'Le Havre', 'country': 'France', 'facility': 'Centre Hospitalier du Havre', 'geoPoint': {'lat': 49.49346, 'lon': 0.10785}}], 'overallOfficials': [{'name': 'Bérengère Beauplet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Caen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Francois Baclesse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}