Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-02-03 @ 6:04 AM
Study NCT ID:
NCT02906592
Status:
COMPLETED
Last Update Posted:
2018-01-11
First Post:
2016-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using a Geriatric Oncology Assessment to Link With Services
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-09', 'studyFirstSubmitDate': '2016-09-15', 'studyFirstSubmitQcDate': '2016-09-15', 'lastUpdatePostDateStruct': {'date': '2018-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in referral patterns', 'timeFrame': 'retrospective data from 1/1/2013-7/7/2016', 'description': 'Comparison of historical and post GOA service referral patterns'}, {'measure': 'Time to complete the brief GOA', 'timeFrame': '6 months'}, {'measure': 'Number of referrals completed', 'timeFrame': '6 months'}, {'measure': 'Number of patients who needed help completing the brief GOA', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '29958815', 'type': 'DERIVED', 'citation': 'Zullig LL, Kimmick G, Smith V, Little K, Bosworth HB, Gonzales S, Oakes MM, Shelby RA, Owen L, Altomare IP. Using a geriatric oncology assessment to link with services (GOAL). J Geriatr Oncol. 2019 Jan;10(1):164-168. doi: 10.1016/j.jgo.2018.06.004. Epub 2018 Jun 27.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to implement a brief geriatric oncology assessment (GOA) in a community-based oncology clinic, the Scotland Cancer Treatment Center - a clinic within the Duke Cancer Network, located in the rural, low resource Scotland County community of North Carolina. Secondly, the investigators will evaluate the effectiveness of the brief GOA by comparing historical and post-GOA service referral patterns and adherence to planned cancer therapy. For this study, the investigators will prospectively enroll up to 60 patients who have been diagnosed and/or treated for cancer to complete the brief GOA. In addition to these 60 patients, the investigators will also conduct retrospective chart reviews on 120 patients that would be eligible for this study to evaluate past referral patterns. Eligible and consented patients will complete the brief GOA at the Scotland Cancer Treatment Center alongside their normal clinic appointment. The investigators will assess impact on the healthcare system by evaluating referral patterns (i.e., how many, what type of services) using the brief GOA data and EHR data. The study value includes the possibility for recognition and access to additional health care referrals if needed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Geriatric (60 years or older) patients in a community-based cancer clinic at Scotland Memorial Hospital. They serve a racially diverse (e.g., 35% African American, 10% Native American), elderly (e.g., 65% \\>65 years), rural, low resource community with over 20% of the population living in poverty.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIn order to be included in the project, patients must be:\n\n1. Diagnosed for a solid tumor cancer (breast, lung, colon, rectal, colorectal (unspecified), pancreas, esophageal)\n2. Diagnosis date within 12 months of identification\n3. Receiving care at Scotland Cancer Treatment Center\n4. Aged 60 years or older at the time of the visit\n5. Planned therapy in the medical oncology clinic at the Scotland Cancer Treatment Center\n\nExclusion Criteria:\n\n1. Diagnosis of metastatic cancer with \\<12 months life expectancy\n2. Planned cancer therapy as surgery only\n3. Receiving palliative or hospice care services (i.e., proxy for \\<12 months life expectancy)\n4. Language (not proficient in English)\n5. Nursing home/long-term care facility resident\n6. Active diagnosis of psychosis (has been hospitalized in the last 30 days), schizophrenia, severe intellectual or developmental disabilities, or dementia\n7. Patient deemed not fit/good candidate for study per provider recommendation'}, 'identificationModule': {'nctId': 'NCT02906592', 'acronym': 'GOAL', 'briefTitle': 'Using a Geriatric Oncology Assessment to Link With Services', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Using a Geriatric Oncology Assessment to Link With Services (GOAL)', 'orgStudyIdInfo': {'id': 'Pro00073547'}}, 'contactsLocationsModule': {'locations': [{'zip': '28352', 'city': 'Laurinburg', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Scotland Cancer Treatment Center', 'geoPoint': {'lat': 34.77405, 'lon': -79.46282}}], 'overallOfficials': [{'name': 'Leah Zullig, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Duke Cancer Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}