Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-26 @ 4:57 PM
Study NCT ID:
NCT04686851
Status:
RECRUITING
Last Update Posted:
2023-12-13
First Post:
2020-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015577', 'term': 'Geriatric Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Clinical Trial with 2 randomized 1:1 parallel study groups'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 322}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-12', 'studyFirstSubmitDate': '2020-10-26', 'studyFirstSubmitQcDate': '2020-12-23', 'lastUpdatePostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'physical function for patients receiving palliative oncologic treatment', 'timeFrame': '3 months', 'description': 'measured by 30 seconds Chair Stand Test, number of repetitions in a 30 seconds time period.'}, {'measure': 'unplanned hospital admissions for patients receiving adjuvant oncologic treatment', 'timeFrame': '6 months', 'description': 'number of unplanned hospitalisations including admissions to Oncologic Department, Emergency Department and Medical Departments. Data will be retrieved trough review of electronic medical records.'}], 'secondaryOutcomes': [{'measure': 'Physical functional for patients receiving curative oncologic treatment', 'timeFrame': '3 months', 'description': 'measured by 30 seconds Chair Stand Test, number of repetitions in a 30 seconds time period.'}, {'measure': 'Physical functional for patients receiving curative oncologic treatment', 'timeFrame': '6 months', 'description': 'measured by 30 seconds Chair Stand Test, number of repetitions in a 30 seconds time period.'}, {'measure': 'Physical functional for patients receiving palliative oncologic treatment', 'timeFrame': '6 months', 'description': 'measured by 30 seconds Chair Stand Test, number of repetitions in a 30 seconds time period.'}, {'measure': 'number of unplanned hospital admissions for patients receiving palliative oncologic treatment', 'timeFrame': '6 months', 'description': 'Number of unplanned hospitalisations including admissions to Oncologic Department, Emergency Department and Medical Departments. Data will be retrieved trough review of electronic medical records.'}, {'measure': 'Health-related Quality of life', 'timeFrame': '12 months', 'description': 'Measured by EORTC-QLQ-C30'}, {'measure': 'Health-related Quality of life', 'timeFrame': '12 months follow-up', 'description': 'Measured by EORTC-QLQ-ELD14'}, {'measure': 'Elderly Functional Index Score (ELFI-score)', 'timeFrame': '6 months', 'description': 'Self reported functioning score. It is a composite score derived from the three scales "physical functioning", "Role functioning" and Social Functioning", from the quality of life questionnaire EORTC-QLQ-C30 and the scale "Mobility" from the quality of life questionnaire EORTC-QLQ-ELD-14. The range is (12-48), with a higher score being a better outcome.'}, {'measure': 'Number of patients who experience oncologic treatment toxicity', 'timeFrame': '6 months', 'description': 'Treatment toxicity grade 3+ evaluated with Common Terminology Criteria for Adverse Events'}, {'measure': 'Number of patients with adherence to initial oncologic treatment plan', 'timeFrame': '6 months', 'description': 'Registration of dose reductions, discontinuations and delays of intended cancer treatment.'}, {'measure': 'Degree of Polypharmacy (PP)', 'timeFrame': '3 months', 'description': 'Degree of polypharmacy. Polypharmacy is defined as daily use of more than 5 prescription drugs.'}, {'measure': 'Number of potential Inappropriate Medications (PIM)', 'timeFrame': '3 months', 'description': 'Using the Screening Tool for Older Persons Prescriptions (STOPP) criteria. Number of PIM will be registered for each patient'}, {'measure': 'Number of Potential Drug Interactions (PDI)', 'timeFrame': '3 months', 'description': "Using Stockley's Drug Interaction Database. Number of PDI will be registered for each patient"}, {'measure': 'Overall survival', 'timeFrame': '12 months', 'description': 'Measured from Geriatric 8 screening to time of death'}, {'measure': 'Cancer specific survival', 'timeFrame': '12 months', 'description': 'Measured from Geriatric 8 screening to time of death in patients with residual cancer'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Frailty', 'Aged', 'Neoplasms', 'Cancer Patients', 'Geriatric Screening', 'Geriatric 8', 'Geriatric Assessment', 'Randomized Clinical Trial'], 'conditions': ['Frailty', 'Cancer', 'Age']}, 'referencesModule': {'references': [{'pmid': '37939628', 'type': 'DERIVED', 'citation': 'Giger AW, Ditzel HM, Ditzel HJ, Ewertz M, Jorgensen TL, Pfeiffer P, Lund CM, Ryg J. Effects of comprehensive geriatric assessment-guided interventions on physical performance and quality of life in older patients with advanced cancer: A randomized controlled trial (PROGNOSIS-RCT). J Geriatr Oncol. 2024 Jan;15(1):101658. doi: 10.1016/j.jgo.2023.101658. Epub 2023 Nov 6.'}, {'pmid': '34362713', 'type': 'DERIVED', 'citation': 'Giger AW, Ditzel HM, Jorgensen TL, Ditzel HJ, Mohammadnejad A, Ewertz M, Pfeiffer P, Lund CM, Ryg J. Predictive value of geriatric oncology screening and geriatric assessment of older patients with cancer: A randomized clinical trial protocol (PROGNOSIS-RCT). J Geriatr Oncol. 2022 Jan;13(1):116-123. doi: 10.1016/j.jgo.2021.07.005. Epub 2021 Aug 4.'}]}, 'descriptionModule': {'briefSummary': 'A Randomized Clinical Trial examining the effects of Comprehensive Geriatric Assessment as an add on to oncologic treatment. Participants included are cancer patients found eligible for oncologic treatment, age 70 or more, and screened frail with the Geriatric 8 screening tool.', 'detailedDescription': 'This study aims to examine the effects of Comprehensive Geriatric Assessment and interventions on prognosis in the older frail cancer patient in a Randomized Clinical Trial design.\n\nPatients screened frail with the Geriatric 8 screening tool, aged 70 or more, and found eligible for oncologic treatment, will be included. We plan to enrol a total of 322 cancer patients for 12 months. Participants will be allocated randomly to either interventional or control group.\n\nParticipants in the interventional group will be offered a Comprehensive Geriatric Assessment and intervention at the start-up of cancer treatment. The Comprehensive Geriatric Assessment will be an add on to standardized cancer treatment offered at the Oncologic Outpatient Clinic at Odense University Hospital.\n\nComprehensive Geriatric Assessment will be performed by a team consisting of a doctor, nurse and physiotherapist. If needed, referral to a dietician or an occupational therapist for further evaluation will be made. The health issues are assessed using validated tests based on a Danish version of the Geriatric Core Dataset (G-CODE). Follow-up on Comprehensive Geriatric Assessment is scheduled for one month after initial evaluation.\n\nThe randomized groups will be compared with respect to primary and secondary endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 70 years\n* Living in the region of Southern Denmark\n* Newly diagnosed solid tumours assessed eligible for antineoplastic treatment\n* Vulnerable or frail (G8 ≤ 14)\n\nExclusion Criteria:\n\n* Inability to speak or understand Danish\n* Inability to give informed consent\n* Already consulting geriatric outpatient clinic\n* Already receiving active treatment for other coexisting solid tumours, haematologic cancers, or non-melanoma skin cancer or has received oncologic treatment the past year'}, 'identificationModule': {'nctId': 'NCT04686851', 'acronym': 'PROGNOSIS-RCT', 'briefTitle': 'Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers (PROGNOSIS-RCT)', 'orgStudyIdInfo': {'id': 'PROGNOSIS-RCT'}, 'secondaryIdInfos': [{'id': 'R247-A14382', 'type': 'OTHER_GRANT', 'domain': 'Danish Cancer Society'}, {'id': '20/ 17768', 'type': 'OTHER', 'domain': 'Region of Southern Denmark'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Comprehensive Geriatric Assessment and follow-up as add on to standard oncologic care', 'interventionNames': ['Other: Comprehensive Geriatric Assessment and follow-up']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'standard oncologic care according to national guidelines'}], 'interventions': [{'name': 'Comprehensive Geriatric Assessment and follow-up', 'type': 'OTHER', 'description': 'All patients will receive standardized oncological treatment according to national guidelines. For patients randomized to the intervention arm, a full Comprehensive Geriatric Assessment (CGA) and corresponding interventions on identified health issues will be performed alongside oncologic treatment. The domains are assessed using validated tests based on a Danish version of the Geriatric Core Dataset (G-CODE). The domains are cognition, mood, comorbidity, functional status, physical status, polypharmacy, nutrition, fall risc and social support. The CGA will be performed by the PhD-student (geriatric resident) or a geriatrician together with geriatric nurses at the Department of Geriatric Medicine, OUH. Nutritional status and interventions are assessed by a dietician. A physical therapist will evaluate the physical performance as part of the CGA.\n\nFollow-up on initial treatment plan is scheduled to one month after baseline CGA.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'state': 'Southern Denmark', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jesper Ryg, MD, Prof.', 'role': 'CONTACT', 'email': 'jesper.ryg@rsyd.dk', 'phone': '60152610', 'phoneExt': '0045'}], 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'centralContacts': [{'name': 'Jesper Ryg, MD', 'role': 'CONTACT', 'email': 'Jesper.Ryg@rsyd.dk', 'phone': '60152610', 'phoneExt': '0045'}], 'overallOfficials': [{'name': 'Ann-Kristine W Giger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Geriatric Medicine, Odense University Hospital, Odense'}, {'name': 'Cecilia M Lund, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Medicine, Herlev and Gentofte University Hospital, Copenhagen'}, {'name': 'Per Pfeiffer, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Clinical Oncology, Odense University Hospital, Odense'}, {'name': 'Trine L Jørgensen, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Clinical Oncology, Odense University Hospital, Odense'}, {'name': 'Marianne Ewertz, MD, DMSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of Clinical Research, University of Southern Denmark, Odense'}, {'name': 'Henrik Ditzel, MD, DMSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Department og Geriatric Medicine, Odense University Hospital, Odense'}, {'name': 'Jesper Ryg, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Geriatric Medicine, Odense University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Southern Denmark', 'class': 'OTHER'}, {'name': 'Danish Cancer Society', 'class': 'OTHER'}, {'name': 'Academy of Geriatric Cancer', 'class': 'UNKNOWN'}, {'name': 'Odense Patient Data Explorative Network', 'class': 'OTHER'}, {'name': 'Region of Southern Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ann-Kristine Weber Giger', 'investigatorAffiliation': 'Odense University Hospital'}}}}