Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-30 @ 1:45 AM
Study NCT ID:
NCT03419468
Status:
COMPLETED
Last Update Posted:
2022-08-10
First Post:
2018-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LCI-GER-NOS-TAB-001: Tablet for Geriatric Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-12', 'size': 210875, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-08-05T12:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-05', 'studyFirstSubmitDate': '2018-01-11', 'studyFirstSubmitQcDate': '2018-01-26', 'lastUpdatePostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survey completion rate', 'timeFrame': '12 months', 'description': 'Assess and compare the proportions of subjects completing, defined as recording responses for at least 70% of actionable questions of the SGAM in subjects aged 70 years or older with malignancy using an iPad tablet versus written questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Rate of survey completion without assistance', 'timeFrame': '12 months', 'description': 'To assess and compare the proportions of subjects completing the SGAM without assistance using an iPad tablet versus written questionnaire.'}, {'measure': 'Total time of interaction with iPad survey', 'timeFrame': '12 months', 'description': 'To evaluate and compare the total times of interaction with the SGAM using an iPad tablet versus written questionnaire in both all evaluable subjects and the subset of evaluable subjects completing the SGAM.'}, {'measure': 'Percentage of recorded responses', 'timeFrame': '12 months', 'description': 'To evaluate and compare the distributions of percentages of recorded responses on actionable questions (from 0% to 100%) on the SGAM using an iPad tablet versus written questionnaire in both all evaluable subjects and the subset of evaluable subjects completing the SGAM.'}, {'measure': 'Rate of technical issues within iPad group', 'timeFrame': '12 months', 'description': 'To describe the rate of technical issues experienced by iPad survey users.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Self Geriatric Assessment Measure (SGAM)']}, 'descriptionModule': {'briefSummary': 'The Self Geriatric Assessment Measure \\[SGAM\\] is based on a standard diagnostic tool used to evaluate geriatric cancer patients in order to determine the appropriateness of cancer directed therapy at LCI. This questionnaire has sections that matches portions of a self-administered geriatric assessment in patients aged 70 or older with malignancy. The prolonged duration of time needed to complete the assessment makes its performance less feasible in standard practice settings.\n\nIn previously published studies the Cancer Specific Geriatric Assessment (CSGA) has been provided both via written questionnaire and by personal computer in subjects 70 years of age or older. With improvements in technology, the goal is to evaluate the feasibility of administering the SGAM via an iPad tablet and compare results to both gold standard paper format and prior desktop computer data.\n\nThis study proposes the use of an iPad tablet to administer the SGAM may help:\n\nImprove the completion rate of the SGAM assessment Reduction in the time of completion Improvement in the accuracy of reporting', 'detailedDescription': 'Primary Objective\n\nAssess and compare the proportions of subjects completing, defined as recording responses for at least 70% of actionable questions of the Self Geriatric Assessment Measure (SGAM) in subjects aged 70 years or older with malignancy using an iPad tablet versus written questionnaire.\n\nSecondary Objectives\n\nTo assess and compare the proportions of subjects completing the SGAM without assistance using an iPad tablet versus written questionnaire.\n\nTo evaluate and compare the total times of interaction with the SGAM using an iPad tablet versus written questionnaire in both all evaluable subjects and the subset of evaluable subjects completing the SGAM.\n\nTo evaluate and compare the distributions of percentages of recorded responses on actionable questions (from 0% to 100%) on the SGAM using an iPad tablet versus written questionnaire in both all evaluable subjects and the subset of evaluable subjects completing the SGAM.\n\nTo describe the rate of technical issues experienced by iPad survey users.\n\nTo assess and compare the completion rates and times to completion of the gold standard written format.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nSubjects must meet all of the following criteria:\n\n* At least 70 years of age\n* Histologically or cytologically confirmed malignancy within the past 1 year\n* Ability to read and understand English\n* Willingness to complete either tablet or paper based assessment independently and without assistance from caregiver, if applicable\n* Willingness and ability to understand and sign a written informed consent document\n\nExclusion Criteria\n\nSubjects must not meet any of the following criteria:\n\n* Any prior history of whole brain radiation therapy for known brain metastasis\n* Known cerebrovascular event within the last 4 weeks from enrollment\n* Known to be legally blind or has a history of severe hearing loss that could impair ability to complete questionnaire in the opinion of the investigator'}, 'identificationModule': {'nctId': 'NCT03419468', 'briefTitle': 'LCI-GER-NOS-TAB-001: Tablet for Geriatric Assessment', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'LCI-GER-NOS-TAB-001: Pilot Study of a Tablet to Administer the Cancer-Specific Geriatric Assessment (CSGA) in Geriatric Patients With Cancer', 'orgStudyIdInfo': {'id': 'LCI-GER-NOS-TAB-001'}, 'secondaryIdInfos': [{'id': '00023842', 'type': 'OTHER', 'domain': 'Advarra IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'iPad administration of Self Geriatric Assessment Measure (SGAM)', 'interventionNames': ['Other: Self Geriatric Assessment Measure (SGAM)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Paper survey administration of Self Geriatric Assessment Measure (SGAM)', 'interventionNames': ['Other: Self Geriatric Assessment Measure (SGAM)']}], 'interventions': [{'name': 'Self Geriatric Assessment Measure (SGAM)', 'type': 'OTHER', 'description': 'Self Geriatric Assessment Measure', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Levine Cancer Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Daniel Haggstrom, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}