Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-02-02 @ 11:23 AM
Study NCT ID:
NCT06504628
Status:
COMPLETED
Last Update Posted:
2025-03-25
First Post:
2024-07-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Falls Among the Older Patients Treated for Cancer in Normandy's Outclinics: Screening and Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 328}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2024-07-10', 'studyFirstSubmitQcDate': '2024-07-10', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of each of the three levels of fall-risk', 'timeFrame': 'Day 1', 'description': 'describe the distribution of patients in mild, intermediate and high risk for falling'}], 'secondaryOutcomes': [{'measure': 'look for association between high-risk categorization and rural place of residence, gender, age bracket (65-74 and 75 and over), investigating center, type of cancer (location).', 'timeFrame': 'Day 1'}, {'measure': 'Describe the rate of high-risk patients who will have benefited from (full or partial) implementation of recommended interventions according to 3-month follow-up.', 'timeFrame': '3 mnths'}, {'measure': 'among high-risk patients followed up at 3 months, look for an association between the absence ofimplementation of recommendations and social, medical characteristics and motive', 'timeFrame': '3 mnths'}, {'measure': 'describe the Average number of STOPPFALL medications per patient. Rate of patients with at least one oncologydrug listed as a fall risk (CIPN), in the 3 fall risk categories', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aged', 'outpatients', 'cancer', 'accidental falls'], 'conditions': ['Aged Patients Treated for Cancer in Outclinics']}, 'descriptionModule': {'briefSummary': 'The French Plan National AntiChute (published on February 21, 2022) and international recommendations on falls prevention (Age Ageing,September 2022) recommend identifying the risk of falling in people aged 65 and over, at least once a year during a follow-up consultation. The presence of chronic illness such as cancer increases the risk for falling. Recommendations suggest targeted preventive interventions according to the risk level, and early reassessment at 3 months in case of high risk.\n\nThis study consists of a cross-sectional survey conducted during a week dedicated to patient safety (September 16-20, 2024), to identify the prevalence of patients at high risk for falling, requiring enhanced care. The relation between high risk for falling and social and oncological characteristics will be studied. A 3-month telephone follow-up will identify any obstacles to implementing the recommendations in this high-risk group.\n\nThis multicenter cross-sectional prospective study is exploratory.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 65 and over treated for cancer or haematological malignancy in public and private outclinics -hospitals in Normandy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 65 or over\n* undergoing treatment for cancer or hematological malignancy (oral or injectable systemic treatment, radiotherapy)\n* covered by health insurance\n* having read the information document and no objection\n* French-speaking\n* Autonomous ( with occasional assistance with instrumental daily activities),\n\nExclusion Criteria:\n\n* refusal to participate\n* unable to communicate\n* dependent (requiring geriatric care)'}, 'identificationModule': {'nctId': 'NCT06504628', 'acronym': 'CHUPACHOUP', 'briefTitle': "Falls Among the Older Patients Treated for Cancer in Normandy's Outclinics: Screening and Prevention", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'CHUtes Chez Les Personnes Agées traitées Pour Cancer Dans Les HOpitaUx Normands : repérage et Prévention', 'orgStudyIdInfo': {'id': '2024-A00979-38'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'low risk for fall subgroup', 'description': 'according to Manuel Montero-Odasso M, Nathalie van der Velde, Finbarr C Martin, Mirko Petrovic, Maw Pin Tan, Jesper Ryg, et al. World guidelines for falls prevention and management for older adults: a global initiative. Age and Ageing, Volume 51, Issue 9, September 2022', 'interventionNames': ['Diagnostic Test: screening risk for falling and identifiy the risk level low-intermediate-high']}, {'label': 'intermediate risk for fall subgroup', 'description': 'according to Manuel Montero-Odasso M, Nathalie van der Velde, Finbarr C Martin, Mirko Petrovic, Maw Pin Tan, Jesper Ryg, et al. World guidelines for falls prevention and management for older adults: a global initiative. Age and Ageing, Volume 51, Issue 9, September 2022', 'interventionNames': ['Diagnostic Test: screening risk for falling and identifiy the risk level low-intermediate-high']}, {'label': 'high risk for fall subgroup', 'description': 'according to Manuel Montero-Odasso M, Nathalie van der Velde, Finbarr C Martin, Mirko Petrovic, Maw Pin Tan, Jesper Ryg, et al. World guidelines for falls prevention and management for older adults: a global initiative. Age and Ageing, Volume 51, Issue 9, September 2022.\n\nThose patients will be contacted 3 mnths after inclusion for follow-up assessment', 'interventionNames': ['Diagnostic Test: screening risk for falling and identifiy the risk level low-intermediate-high', 'Diagnostic Test: 3 mnth-follow-up']}], 'interventions': [{'name': 'screening risk for falling and identifiy the risk level low-intermediate-high', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['prevention by handing over a leeflet listing recommendations to patients and general practitionners'], 'description': '3 key questions: Any posiitve answer to a) Has fallen in the past year? b) Feels unsteady when standing or walking? or c) Worries about falling? prompts to "fall severity" step.\n\nif "no" at the three questions= low level of fall-risk Fall severity: fall with injuires, laying on the ground with no capacity to get up, or a visit to emergency room, or loss of conscienciousness/suspected syncope. or Frailty (Clinical Frailty Scale)= if positive, high risk otherwise, 4 meter-walk test: if =\\<0.8m/sec= intermediate risk if \\>0.8m/sec=intermediate risk', 'armGroupLabels': ['high risk for fall subgroup', 'intermediate risk for fall subgroup', 'low risk for fall subgroup']}, {'name': '3 mnth-follow-up', 'type': 'DIAGNOSTIC_TEST', 'description': "patient's phone call, and data collected from electronic medical record", 'armGroupLabels': ['high risk for fall subgroup']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'state': 'Normandy', 'country': 'France', 'facility': 'Caen UH', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Avranches', 'country': 'France', 'facility': 'Centre de radiothérapie de la Baie', 'geoPoint': {'lat': 48.68436, 'lon': -1.35686}}, {'city': 'Caen', 'country': 'France', 'facility': 'Centre de radiothérapie Maurice Tubiana/Polyclinique Parc', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Caen', 'country': 'France', 'facility': 'CLCC François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Cherbourg', 'country': 'France', 'facility': 'Centre Hospitalier Public du Cotentin', 'geoPoint': {'lat': 49.63984, 'lon': -1.61636}}, {'city': 'Évreux', 'country': 'France', 'facility': 'Centre Hospitalier Evreux-VErnon', 'geoPoint': {'lat': 49.02414, 'lon': 1.15082}}, {'city': 'Le Havre', 'country': 'France', 'facility': 'Hôpital Privé de l Estuaire', 'geoPoint': {'lat': 49.49346, 'lon': 0.10785}}, {'city': 'Lisieux', 'country': 'France', 'facility': 'Centre Hospitalier Robert Bisson', 'geoPoint': {'lat': 49.1466, 'lon': 0.22925}}, {'zip': '76000', 'city': 'Rouen', 'country': 'France', 'facility': 'Becquerel Cancer CEnter', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Rouen', 'country': 'France', 'facility': 'CHU de Rouen Charles Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}