Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-29 @ 6:45 PM
Study NCT ID:
NCT00740961
Status:
TERMINATED
Last Update Posted:
2020-07-27
First Post:
2008-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Older Patients With Newly Diagnosed Breast Cancer or Colon Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'D000073216', 'term': 'Mental Status and Dementia Tests'}, {'id': 'D000067250', 'term': 'Psychiatric Rehabilitation'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D009483', 'term': 'Neuropsychological Tests'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Approximately 13mls of blood will be drawn at each of the three time-points for testing for biologic correlates of frailty (pre study, mid-study and post-study).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'whyStopped': 'low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-23', 'studyFirstSubmitDate': '2008-08-22', 'studyFirstSubmitQcDate': '2008-08-22', 'lastUpdatePostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of impaired domains on Comprehensive Geriatric Assessment (CGA)', 'timeFrame': 'at baseline and 12 months later.'}, {'measure': 'Chemotherapy adherence as measured by dose reduction, dose delay, and grade 3-5 toxicities', 'timeFrame': 'Patients are followed for 1 year for chemotherapy adherence and survival.'}, {'measure': 'Vulnerable Elders Survey scores', 'timeFrame': 'at baseline and 12 months later.'}, {'measure': 'Functional decline', 'timeFrame': 'at baseline and 12 months later.'}, {'measure': 'Time to death', 'timeFrame': 'Patients are followed for 1 year for chemotherapy adherence and survival.'}], 'secondaryOutcomes': [{'measure': 'Scores of individual battery of tools included in the CGA', 'timeFrame': 'at baseline and 12 months later'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['psychosocial effects of cancer and its treatment', 'cognitive/functional effects', 'breast cancer', 'colon cancer'], 'conditions': ['Breast Cancer', 'Cognitive/Functional Effects', 'Colorectal Cancer', 'Psychosocial Effects of Cancer and Its Treatment']}, 'descriptionModule': {'briefSummary': "RATIONALE: Learning about changes over time in older patients' ability to function after receiving chemotherapy for breast or colon cancer may help doctors learn about the long-term effects of treatment and plan the best treatment.\n\nPURPOSE: This clinical trial is studying older patients with newly diagnosed breast cancer or colon cancer.", 'detailedDescription': 'OBJECTIVES:\n\n* Determine the correlation between the Vulnerable Elders Survey (VES-13) and the battery of Comprehensive Geriatric Assessment tools among breast and colon cancer patients, 65 years and older, in an outpatient setting.\n* Assess and compare the abilities of the VES-13 and the battery of Comprehensive Geriatric Assessment tools to predict chemotherapy adherence among these patients.\n* Examine the validity of the VES-13 screening tool to identify increased risk of death from all causes at one year after initial VES-13 screening in these patients.\n* Examine the validity of the VES-13 screening tool to identify increased risk of functional decline at one year after initial VES-13 screening in these patients.\n\nOUTLINE: Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.\n\nPatients are followed for 1 year for chemotherapy adherence and survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Primary Care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed breast or colon cancer\n\n * Newly diagnosed disease\n * Any stage disease\n* Undergoing treatment at the Ireland Cancer Center, University Hospitals Case Medical Center Site\n* Scheduled to start a new chemotherapy regimen (objective II only)\n* Not concurrently enrolled in a GEM trial (objectives II, III, and IV)\n* Hormone receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* Understands English\n* Menopausal status not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* See Diseases Characteristics'}, 'identificationModule': {'nctId': 'NCT00740961', 'briefTitle': 'Older Patients With Newly Diagnosed Breast Cancer or Colon Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'The Vulnerable Elders Survey Study of Older Cancer Patients', 'orgStudyIdInfo': {'id': 'CASE8Y07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with cancer', 'description': 'Patients ≥ 65 years with new stage I-III breast or colon cancer seeking care. Patients will be matched on baseline scores, age and sex. Patients will be age and sex matched due to the known relation between inflammatory markers and demographic characteristics39,40, and will be matched on baseline VES scores to ensure similar baseline VES-13 scores between groups and which will then allow us to then assess effect of cancer treatment on outcomes.', 'interventionNames': ['Behavioral: compliance monitoring', 'Drug: systemic chemotherapy', 'Other: medical chart review', 'Other: study of socioeconomic and demographic variables', 'Other: survey administration', 'Procedure: cognitive assessment', 'Procedure: psychosocial assessment and care']}, {'label': 'Patients without cancer', 'description': 'non-cancer patients, seeking care at out-patient clinics', 'interventionNames': ['Behavioral: compliance monitoring', 'Other: medical chart review', 'Other: study of socioeconomic and demographic variables', 'Other: survey administration', 'Procedure: cognitive assessment', 'Procedure: psychosocial assessment and care']}], 'interventions': [{'name': 'compliance monitoring', 'type': 'BEHAVIORAL', 'description': 'Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.', 'armGroupLabels': ['Patients with cancer', 'Patients without cancer']}, {'name': 'systemic chemotherapy', 'type': 'DRUG', 'description': "Learning about changes over time in older patients' ability to function after receiving chemotherapy for breast or colon cancer", 'armGroupLabels': ['Patients with cancer']}, {'name': 'medical chart review', 'type': 'OTHER', 'description': 'A limited review of medical records for the sole purpose of evaluating patients for study eligibility will be undertaken by the research team.', 'armGroupLabels': ['Patients with cancer', 'Patients without cancer']}, {'name': 'study of socioeconomic and demographic variables', 'type': 'OTHER', 'description': 'Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.', 'armGroupLabels': ['Patients with cancer', 'Patients without cancer']}, {'name': 'survey administration', 'type': 'OTHER', 'description': 'Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.', 'armGroupLabels': ['Patients with cancer', 'Patients without cancer']}, {'name': 'cognitive assessment', 'type': 'PROCEDURE', 'description': 'Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.', 'armGroupLabels': ['Patients with cancer', 'Patients without cancer']}, {'name': 'psychosocial assessment and care', 'type': 'PROCEDURE', 'description': 'Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.', 'armGroupLabels': ['Patients with cancer', 'Patients without cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'facility': 'UH-LUICC', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '44122', 'city': 'Orange', 'state': 'Ohio', 'country': 'United States', 'facility': 'UH-Chagrin Highlands', 'geoPoint': {'lat': 41.44978, 'lon': -81.48067}}, {'zip': '44121', 'city': 'South Euclid', 'state': 'Ohio', 'country': 'United States', 'facility': 'UH-Green Road', 'geoPoint': {'lat': 41.52311, 'lon': -81.51846}}, {'zip': '44145', 'city': 'Westlake', 'state': 'Ohio', 'country': 'United States', 'facility': 'UH-Westlake', 'geoPoint': {'lat': 41.45532, 'lon': -81.91792}}], 'overallOfficials': [{'name': 'Cynthia Owusu, MD, MSC', 'role': 'STUDY_CHAIR', 'affiliation': 'Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}