Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-02-19 @ 5:33 AM
Study NCT ID:
NCT07073703
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-07-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Personalized 6-month Programme on Frailty in Older Patients Treated for Bladder or Kidney Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C029014', 'term': 'diacetamate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-07-10', 'studyFirstSubmitQcDate': '2025-07-10', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient frailty', 'timeFrame': 'Day : 1 and Month : 6', 'description': "Frailty will be measured using the walking distance (in metres) achieved during the 6-minute walk test (6MWT) 6 months after the patient's inclusion."}], 'secondaryOutcomes': [{'measure': 'Cumulative Illness Rating Scale for Geriatrics (CIRS-G)', 'timeFrame': 'Months : 1, 2, 3 and 6', 'description': 'The CIRS (Cumulative Illness Rating Scale) score provides a relevant comparison of the medical burden and treatment outcomes in geriatric patients with variable and complex pathologies.\n\nThe score ranges from 0: no problem to 4: very serious problem.'}, {'measure': "Fried's frailty phenotype (FP)", 'timeFrame': 'Months : 1, 2, 3 and 6', 'description': "Frailty will be measured using Fried's frailty phenotype (FP), defined by exhaustion (EX), unexplained weight loss (WL), weakness (WK), sluggishness (SL) and low physical activity (LA). Three or more components define the frailty state, and one or two the pre-fragility state."}, {'measure': 'level of physical activity', 'timeFrame': 'Months : 1, 2, 3 and 6', 'description': 'Objective measures of PA (in MET-hours/week) via accelerometry (Actigraph GT3x, Pensacola, Florida, USA) and subjective measurements of PA (in METhours/week) using the e-Adult Physical Activity Questionnaire (EA SNA-EPIS, Université Jean Monnet, Saint-Etienne, France).'}, {'measure': 'level of sedentary lifestyle', 'timeFrame': 'Months : 1, 2, 3 and 6', 'description': 'Objective measures of sedentary time (in h/d) via accelerometry (Actigraph GT3x, Pensacola, Florida, USA) and subjective measurements of sedentary behaviour (in hours/day) using the e-Adult Physical Activity Questionnaire (EA SNA-EPIS, Université Jean Monnet, Saint-Etienne, France).'}, {'measure': 'Nutritional status', 'timeFrame': 'Months : 1, 2, 3 and 6', 'description': 'With the Mini Nutritional Assessment (MNA) and albumin analysis in g/l, a level \\<35g/l: undernutrition, \\<30g/l: severe undernutrition.'}, {'measure': 'Memory', 'timeFrame': 'Months : 1, 2, 3 and 6', 'description': 'Mini-Mental State Examination (MMSE), which consists of 30 questions and is scored out of 30. The severity of memory impairment is considered mild if the score is above 20, moderate if the score is between 10 and 20, and severe if the score is below 10.'}, {'measure': 'Healthy quality of life', 'timeFrame': 'Months : 1, 2, 3 and 6', 'description': 'With the EORTC-QLC30 version 3. This 30-item questionnaire assesses 15 dimensions of quality of life (5 functional scales: physical, cognitive, social, emotional or psychological and limitations in daily activities; 1 global health/quality of life scale; 9 symptom scales: fatigue, nausea and vomiting, pain, dyspnea, insomnia, loss of appetite, constipation and diarrhea, financial problems related to the disease).'}, {'measure': 'Fatigue', 'timeFrame': 'Months : 1, 2, 3 and 6', 'description': 'With the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F). The questionnaire consists of 13 questions, each of which corresponds to a Likert scale ranging from 0 to 4 (0 = not at all, 4 = very much). A score is obtained out of 52, with the higher the score, the less fatigued the patient is.'}, {'measure': 'Depression', 'timeFrame': 'Months : 1, 2, 3 and 6', 'description': 'Using the Mini Geriatric Depression Scale (GDS) to 4 questions. If the score is greater than 1: high probability of depression, if the score is 0: high probability of no depression.'}, {'measure': 'Muscular strength', 'timeFrame': 'Months : 1, 2, 3 and 6', 'description': 'Muscle strength (in kilogram) on the handgrip.'}, {'measure': 'Balance', 'timeFrame': 'Months : 1, 2, 3 and 6', 'description': 'Assessed using the time (in seconds) taken to complete the Timed Up and Go (TUG). A time ≥ 20 seconds is associated with a risk of falling.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Older people', 'Cancer', 'Bladder', 'Kidney', 'Frailty', 'Surgery'], 'conditions': ['Bladder (Urothelial, Transitional Cell) Cancer', 'Kidney (Renal Cell) Cancer']}, 'descriptionModule': {'briefSummary': "Bladder and kidney cancers are commonly diagnosed in older adults. Surgery remains the primary treatment modality for patients with kidney or bladder cancer. In older patients, common co-morbidities include fatigue, physical deconditioning characterized by reduced cardiorespiratory fitness and progressing sarcopenia, pain- whether disease- related or treatment-induced- and undernutrition. These factors increased the risk of post-operative complications and exacerbate patient frailty.\n\nThe investigators propose a personalized 6-month program both pre- and post-surgery, including adapted physical activity sessions, therapeutic education workshops, and systematic referral to the department's DAPAP program."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of bladder or kidney cancer\n* Surgical treatment\n* No severe cognitive impairment preventing understanding of the protocol\n* Affiliated or entitled to a social security scheme\n* Having received informed information about the study and having co-signed, with the investigator, a consent to participate in the study\n\nExclusion Criteria:\n\n* Surgery already done\n* Significant co-morbidities that contraindicate physical activity: associated cardiac pathologies, respiratory pathologies, disabling joint pathologies, etc.\n* Deprived of liberty or under guardianship\n* Benefiting from a prehabilitation prescription with a private physiotherapist.'}, 'identificationModule': {'nctId': 'NCT07073703', 'acronym': 'FRAGECO', 'briefTitle': 'Effectiveness of a Personalized 6-month Programme on Frailty in Older Patients Treated for Bladder or Kidney Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Effectiveness of a Personalized 6-month Programme on Frailty in Older Patients Treated for Bladder or Kidney Cancer - FRAGECO - Multicenter, Controlled, Randomized Study', 'orgStudyIdInfo': {'id': '24CH124'}, 'secondaryIdInfos': [{'id': '2024-A01991-46', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group will consist of patients with bladder or kidney cancer receiving standard care, which includes a comprehensive assessment by an oncogeriatrician followed by surgery approximately 4 weeks later. Postoperatively, patients will be transferred to a rehabilitation center (SSR) for recovery, in line with standard clinical practice.\n\nAs part of the study protocol, control group patients will undergo additional follow-up assessments alongside their usual care. These follow-ups-conducted at baseline, and at 1, 2, 3 months, and at the final endpoint-will mirror those of the intervention group. They will include patients- completed questionnaires and physical assessments conducted by an adapted physical activity teacher.'}, {'type': 'EXPERIMENTAL', 'label': 'Interventional group', 'description': 'The interventional group will consist of bladder and kidney cancer patients who will follow a personalized 6-month care pathway in addition to standard care. This pathway includes:\n\n* 2 adapted physical activity (APA) sessions per week for 4 weeks prior to surgery\n* 2 APA sessions/ week for 4 weeks following surgery\n* Therapeutic education workshops tailored to individual needs, covering topics as physical activity, nutrition, treatments, fatigue, and relaxation\n* Referral to the department\'s DAPAP for a 12-week "bridge program", consisting of one APA session per week.\n\nThe study will be conducted in the oncogeriatrics departments of Saint-Etienne University Hospital and Loire Private Hospital.', 'interventionNames': ['Procedure: APA', 'Behavioral: Therapeutic education workshops', 'Procedure: DAPAP']}], 'interventions': [{'name': 'APA', 'type': 'PROCEDURE', 'description': '2 adapted physical activity (APA) sessions per week for 4 weeks before and after surgery', 'armGroupLabels': ['Interventional group']}, {'name': 'Therapeutic education workshops', 'type': 'BEHAVIORAL', 'description': 'Therapeutic education workshops tailored to individual needs, covering topics as physical activity, nutrition, treatments, fatigue, and relaxation.', 'armGroupLabels': ['Interventional group']}, {'name': 'DAPAP', 'type': 'PROCEDURE', 'description': 'Referral to the department\'s DAPAP for a 12-week "bridge program", consisting of one session per week.', 'armGroupLabels': ['Interventional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'David HUPIN, MD', 'role': 'CONTACT', 'email': 'david.hupin@chu-st-etienne.fr', 'phone': '(0)477828413', 'phoneExt': '+33'}, {'name': 'Anne-Françoise CHANELIERE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Evolène FAYOLLE, Student', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chu Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '42100', 'city': 'Saint-Etienne', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilie FAVIER, MD', 'role': 'CONTACT', 'email': 'david.hupin@chu-st-etienne.fr', 'phone': '(0)4 77 42 29 59', 'phoneExt': '+33'}, {'name': 'Emilie FAVIER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital privé de la Loire', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'centralContacts': [{'name': 'Evolène FAYOLLE, student', 'role': 'CONTACT', 'email': 'evolene.fayolle@chu-st-etienne.fr', 'phone': '(0)4 77 12 78 35', 'phoneExt': '+33'}, {'name': 'Amandine BAUDOT, Project Manager', 'role': 'CONTACT', 'email': 'amandine.baudot@chu-st-etienne.fr', 'phone': '(0)4 77 82 94 50', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'David HUPIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Saint Etienne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}