Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-31 @ 1:13 PM
Study NCT ID:
NCT01005693
Status:
UNKNOWN
Last Update Posted:
2013-05-15
First Post:
2009-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening Tools to Predict Treatment Outcome in Older Cancer Patients Who Are Undergoing Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073216', 'term': 'Mental Status and Dementia Tests'}, {'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D009483', 'term': 'Neuropsychological Tests'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'SUPPORTIVE_CARE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'lastUpdateSubmitDate': '2013-05-14', 'studyFirstSubmitDate': '2009-10-30', 'studyFirstSubmitQcDate': '2009-10-30', 'lastUpdatePostDateStruct': {'date': '2013-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of applying screening tools (Groningen Frailty Indicator [GFI] and G8) in older patients with cancer'}, {'measure': 'Comparison of the screening tools (GFI and G8) with a comprehensive geriatric assessment (CGA)'}, {'measure': 'Predictive value of the screening tool to undergo standard anticancer treatment in terms of toxicity according to the NCI-CTC'}]}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific'], 'conditions': ['Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Questionnaires that measure how well older patients think, learn, remember, and make judgments and carry out daily activities may improve the ability to plan treatment for patients with cancer.\n\nPURPOSE: This clinical trial is studying testing for fitness to undergo chemotherapy to see how well it works in predicting treatment outcomes in older patients with cancer.', 'detailedDescription': "OBJECTIVES:\n\n* To assess the feasibility of applying screening tools (Groningen Frailty Indicator \\[GFI\\] and G8) and their relationship to treatment outcome in older patients with cancer undergoing standard treatment versus geriatric interventions.\n* To compare the screening tools (GFI and G8) with a comprehensive geriatric assessment (CGA).\n* To evaluate the predictive value of the screening tool to undergo standard anticancer treatment in terms of toxicity.\n* To identify patients that can benefit from a geriatric intervention in order to be able to undergo standard anticancer treatment.\n\nOUTLINE: This is a multicenter study.\n\nAll patients complete screening questionnaires (GFI, G8, and the standardized CGA which consists of the ADL (Katz index) and IADL; the Timed Up and Go; the Cancer and Leukemia Group B adaptation of Charlson Co-morbidity; the Mini Nutritional Assessment; the RAND Social Support Survey Instrument; the Folstein Mini Mental State Examination; and the Geriatric Depression Scale) before the start of anticancer treatment, prior to each course of treatment, and after 1 month of treatment. Patients also undergo physical and cognitive performance measures by a trained member of the research team. Patients are assigned to a group based on fitness for treatment. They may be reassigned after each round of assessments.\n\n* Group 1 (fit to undergo standard treatment): Patients undergo standard treatment.\n* Group 2 (vulnerable): Patients receive specialized care and individualized treatment.\n* Group 3 (frail): Patients receive palliative care and no anticancer chemotherapy or targeted agents.\n\nPatients' medical history, vital signs, performance status, physical examination, and body weight are obtained and recorded. In patients receiving anticancer treatment, all adverse events are graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) and recorded and serious adverse events will be reported according to European Rules."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed cancer\n\n * Undergoing out-patient care\n * Planning to undergo primary chemotherapeutic treatment or treatment with targeted agents for curative or palliative intent\n* No symptomatic brain metastases\n\nPATIENT CHARACTERISTICS:\n\n* Able to understand the Flemish language, give informed consent, and be followed at the investigational site\n* Must be considered eligible for trial participation by the Investigator\n* No severe known dementia\n* No pre-existing major neurological or psychiatric problems\n* No refusal of the standard anticancer strategy as defined by the service instruction book\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT01005693', 'briefTitle': 'Screening Tools to Predict Treatment Outcome in Older Cancer Patients Who Are Undergoing Treatment', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Impact of Frailty in Senior Cancer Patients: Feasibility and Value of Screening Tools and Geriatric Intervention and Predictive Value of a Screening Tool in Relation to Treatment Outcome', 'orgStudyIdInfo': {'id': 'ZNA-2008-FOD-GER001'}, 'secondaryIdInfos': [{'id': 'CDR0000658351', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'EU-20985'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'questionnaire administration', 'type': 'OTHER'}, {'name': 'cognitive assessment', 'type': 'PROCEDURE'}, {'name': 'examination', 'type': 'PROCEDURE'}, {'name': 'management of therapy complications', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-9300', 'city': 'Aalst', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT'}], 'facility': 'Onze Lieve Vrouw Ziekenhuis Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': 'B-2020', 'city': 'Antwerp', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '32-3-280-2339'}], 'facility': 'Ziekenhuis Netwerk Antwerpen Middelheim', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': 'B-2060', 'city': 'Antwerp', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT'}], 'facility': 'Ziekenhuis Netwerk Antwerpen Stuivenberg', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '3500', 'city': 'Hasselt', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT'}], 'facility': 'Virga Jesse Hospital', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}], 'overallOfficials': [{'name': 'Dirk Schrijvers, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ziekenhuis Netwerk Antwerpen (ZNA)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziekenhuis Netwerk Antwerpen (ZNA)', 'class': 'OTHER'}}}}