Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-01-10 @ 12:45 AM
Study NCT ID:
NCT03986502
Status:
COMPLETED
Last Update Posted:
2022-10-14
First Post:
2019-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Financial Navigation Intervention in Improving Financial and Clinical Outcomes in Patients With Newly Diagnosed Gastric or Gastroesophageal Junction Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017410', 'term': 'Practice Guidelines as Topic'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D017408', 'term': 'Guidelines as Topic'}, {'id': 'D011785', 'term': 'Quality Assurance, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-04', 'size': 1414370, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-10-12T16:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-12', 'studyFirstSubmitDate': '2019-06-10', 'studyFirstSubmitQcDate': '2019-06-13', 'lastUpdatePostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants that have experienced Household financial hardship', 'timeFrame': 'Up to 6 months', 'description': 'Financial Hardship is defined as self-report of accrual of debt, taking out loans for cancer treatment or decline in household income \\<=20%'}, {'measure': 'Patient quality of life: FACT-G', 'timeFrame': 'Baseline up to 6 months', 'description': 'Composite score from the FACT-G. A 6-point score change is considered clinically meaningful in US cancer populations.'}, {'measure': 'Subjective financial distress', 'timeFrame': 'Baseline up to 6 months', 'description': 'Assessed using Comprehensive Score for Financial Toxicity-Patient Reported Outcome Measure (COST-FACIT). Mean scores (and standard deviations) at 3 and 6 months will be compared between intervention and control patients and caregivers using two sample t tests. Additionally, will explore the extent to which subjective financial distress correlates with financial hardship by comparing mean scores in those who experience financial hardship in each study arm versus those who do not.'}, {'measure': 'Qualitative assessment of usual care and intervention', 'timeFrame': 'Up to 6 months', 'description': "Usual care arm dyads will be surveyed about availability (or lack), access to, and use of financial assistance via the clinic and community. Intervention arm dyads will be surveyed about availability and use of financial assistance from the clinic, community, and navigation partners. Will evaluate Consumer Education and Training Services (CENTS)'s and Patient Advocate Foundation (PAF)'s documentation and characterize the interventions made on behalf of dyads in subgroups categorized by age, gender, income, and financial fragility. We will review all unresolved issues reported by CENTS and PAF and describe the frequency and type by subgroup. We will describe dyads' use of clinic and community-based financial assistance resources in both study arms across subgroups, noting barriers to access if present."}, {'measure': 'Caregiver quality of life', 'timeFrame': 'Baseline up to 6 months', 'description': 'City of Hope Quality of Life Family version, a well-validated tool with 37 items and 4 subscales (scored 0-10 per item). A change in score of 2 points per item is considered clinically meaningful.'}, {'measure': 'Caregiver burden', 'timeFrame': 'Baseline up to 6 months', 'description': 'Assessed via the social well-being subscale of the City of Hope Quality of Life questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Adenocarcinoma', 'Gastroesophageal Junction Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '38400905', 'type': 'DERIVED', 'citation': 'Bell-Brown A, Hopkins T, Watabayashi K, Overstreet K, Leahy A, Bradshaw E, Gallagher K, Obenchain J, Padron A, Scott B, Flores B, Shankaran V. A proactive financial navigation intervention in patients with newly diagnosed gastric and gastroesophageal junction adenocarcinoma. Support Care Cancer. 2024 Feb 24;32(3):189. doi: 10.1007/s00520-024-08399-1.'}]}, 'descriptionModule': {'briefSummary': 'This trial studies how well a financial navigation intervention works in improving financial and clinical outcomes in patients with newly diagnosed gastric or gastroesophageal junction adenocarcinoma. Financial toxicity is a term used to summarize cancer-related financial hardship, including both the material (e.g. debt) and psychological (e.g. anxiety about costs) aspects. Cancer patients who experience financial toxicity are at greater risk for treatment non-adherence, poorer quality of life, and worse survival. Caregivers also share in this experience of financial toxicity and often spend money on food, medications, and other patient needs in addition to taking time off from work to provide logistical, emotional, and medical support. Financial navigation interventions that address the shared household financial concerns of patients and their caregivers may not only improve the patient outcomes but also improve caregiver burden, quality of life, and ability to perform caregiver roles more effectively.', 'detailedDescription': 'OUTLINE: Participants are randomized to 1 of 2 arms.\n\nARM I (FINANCIAL NAVIGATION PROGRAM): Patients and caregivers watch a web-based financial literacy video and receive information about financial counseling, direct medical cost and healthcare coverage assistance, and indirect and non-medical cost assistance.\n\nARM II (USUAL CARE): Patients and caregivers participate in usual clinic procedures and utilize any available clinic or community-based financial resources.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PATIENT: English-speaking\n* PATIENT: Diagnosis of gastric and/or gastroesophageal junction (GEJ) adenocarcinoma within 6 months of consent (any stage)\n* PATIENT: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2\n* PATIENT: Receiving (or will receive) chemotherapy, radiation, or other systemic therapy (including targeted drug or immune checkpoint inhibitor)\n* CAREGIVER: English-speaking\n\nExclusion Criteria:\n\n• PATIENT: Enrolled in hospice care at the time of enrollment'}, 'identificationModule': {'nctId': 'NCT03986502', 'briefTitle': 'Financial Navigation Intervention in Improving Financial and Clinical Outcomes in Patients With Newly Diagnosed Gastric or Gastroesophageal Junction Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'Pilot Randomized Study of a Proactive Financial Navigation Intervention in Patients With Newly Diagnosed Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma', 'orgStudyIdInfo': {'id': 'RG1005389'}, 'secondaryIdInfos': [{'id': 'NCI-2019-03381', 'type': 'REGISTRY', 'domain': 'NCI / CTRP'}, {'id': '10200', 'type': 'OTHER', 'domain': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (financial navigation program)', 'description': 'Patients and caregivers watch a web-based financial literacy video and receive information about financial counseling, direct medical cost and healthcare coverage assistance, and indirect and non-medical cost assistance.', 'interventionNames': ['Other: Media Intervention', 'Other: Informational Intervention', 'Other: Questionnaire Administration', 'Other: Quality-of-Life Assessment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II (usual care)', 'description': 'Patients and caregivers participate in usual clinic procedures and utilize any available clinic or community-based financial resources. Patients and caregivers will also be provided the financial navigation videos and worksheets from the intervention.', 'interventionNames': ['Other: Best Practice', 'Other: Questionnaire Administration', 'Other: Quality-of-Life Assessment']}], 'interventions': [{'name': 'Media Intervention', 'type': 'OTHER', 'description': 'Watch web-based financial literacy video', 'armGroupLabels': ['Arm I (financial navigation program)']}, {'name': 'Informational Intervention', 'type': 'OTHER', 'description': 'Receive information on financial counseling and medical cost assistance', 'armGroupLabels': ['Arm I (financial navigation program)']}, {'name': 'Best Practice', 'type': 'OTHER', 'otherNames': ['standard of care', 'standard therapy'], 'description': 'Utilize usual clinic procedures and clinic or community-based financial resources', 'armGroupLabels': ['Arm II (usual care)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (financial navigation program)', 'Arm II (usual care)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (financial navigation program)', 'Arm II (usual care)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutch/University of Washington Cancer Consortium', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Veena Shankaran', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}