Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-27 @ 10:32 AM
Study NCT ID:
NCT05402033
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2022-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cancer Clinical Trials Financial Reimbursement Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2022-05-24', 'studyFirstSubmitQcDate': '2022-05-27', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical trial enrollment retention rate measured by COST PROM', 'timeFrame': 'Up to first 60 days after enrollment to a therapeutic cancer trial.', 'description': 'Use COST PROM to calculate the clinical trial enrollment and retention rates of the patients eligible for and participate in the Financial Reimbursement Program (FRP) versus those that decline to participate in the FRP.'}, {'measure': 'Clinical trial enrollment retention rate measured by SAHL', 'timeFrame': 'Up to first 60 days after enrollment to a therapeutic cancer trial.', 'description': 'Use SAHL to calculate the clinical trial enrollment and retention rates of the patients eligible for and participate in the Financial Reimbursement Program (FRP) versus those that decline to participate in the FRP.'}, {'measure': 'Sociodemographic characteristics of the patients measured by COST PROM', 'timeFrame': 'Up to first 60 days after enrollment to a therapeutic cancer trial.', 'description': 'Use COST PROM to determine the sociodemographic characteristics of the patients eligible for and participate in the Financial Reimbursement Program (FRP) versus those that decline to participate in the FRP.'}, {'measure': 'Sociodemographic characteristics of the patients measured by SAHL', 'timeFrame': 'Up to first 60 days after enrollment to a therapeutic cancer trial.', 'description': 'Use SAHL to determine the sociodemographic characteristics of the patients eligible for and participate in the Financial Reimbursement Program (FRP) versus those that decline to participate in the FRP.'}, {'measure': 'Characteristics of patients enrolled in a Financial Reimbursement Program who do versus do not submit expense documentation for reimbursement', 'timeFrame': 'Up to first 60 days after enrollment to a therapeutic cancer trial.', 'description': 'The Financial Reimbursement Program will provide monthly de-identified reports to the Project team on reimbursed expenses by category, and total dollars reimbursed, stratified by study participation. Categories of financial needs/expenses are hotels, flights, parking, gas, tolls, travel companion, bus, subway, taxi/ride hailing app, car/boat service, childcare, internet access, and miscellaneous.'}, {'measure': 'Identify impact of participation in a Financial Reimbursement Program', 'timeFrame': 'Up to first 60 days after enrollment to a therapeutic cancer trial.', 'description': 'Use COST PROM questionnaires to determine factors affecting patient participation decisions .'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer Clinical Trials']}, 'descriptionModule': {'briefSummary': 'To implement a Financial Reimbursement and Outreach Program at clinical sites within the Harold C. Simmons Comprehensive Cancer Center; and evaluate the impact of the program on clinical trial enrollment and demographics, as well as facilitators of and barriers to program participation.', 'detailedDescription': 'The overall purpose of this study is to determine the impact of a Financial Reimbursement Program on recruitment and retention to therapeutic cancer clinical trials, including evaluating program facilitators and barriers, as well as patient acceptability and adoption of the program.\n\nThe procedures involved for this study are surveys and interviews. Subjects will complete two surveys which are expected to take about 10-15 minutes. Some of the subjects will also be invited to complete follow-up interviews after 21 days and between 30 and 90 days. The surveys and interviews are for research purposes only.\n\nStatistical analysis: Two-sample t-tests and chi-square tests to determine the association between socio-demographic variables, financial toxicity, health literacy, and Financial Reimbursement Program participation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Participants will be recruited from among patients seen in the cancer clinics of the Harold C. Simmons Comprehensive Cancer Center, including those at UT Southwestern Medical Center, Parkland Health and Hospital System, and Children's Health. Patients with any cancer type who are informed that they are eligible for participation in any phase therapeutic cancer clinical trial by their treating physician (generally a medical oncologist) will be offered the opportunity to determine if they are interested in and eligible for the Financial Reimbursement Program and this Research Study to evaluate the Program.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be enrolled in a therapeutic cancer clinical trial\n* Speak English or Spanish\n\nExclusion Criteria:\n\n* Not enrolled in a clinical trial\n* Does not speak English or Spanish'}, 'identificationModule': {'nctId': 'NCT05402033', 'briefTitle': 'Cancer Clinical Trials Financial Reimbursement Program', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Enhancement of Access to and Diversity in Cancer Clinical Trials Through a Financial Reimbursement and Outreach Program', 'orgStudyIdInfo': {'id': 'STU-2021-1144'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Survey / Interview Group', 'description': 'All patients (or parent / caregiver, if relevant) who provide informed consent will be asked to complete baseline assessments utilizing validated questionnaires administered through the phone or video call. The clinical research coordinator will input responses into REDCap. Alternatively, patients may request assessments be sent through secure email.\n\nBaseline assessment consisting of sociodemographic items and study eligibility questions (call #1)\n\nIn addition, each patient will complete the Comprehensive Score for financial Toxicity Patient Reported Outcome Measure (COST PROM) and Short Assessment of Health Literacy (SAHL) survey measures.', 'interventionNames': ['Behavioral: Survey / Interview Group']}], 'interventions': [{'name': 'Survey / Interview Group', 'type': 'BEHAVIORAL', 'description': 'Patients with any cancer type who are informed that they may be eligible for participation in any phase therapeutic cancer clinical trial by their treating physician (typically a clinical oncologist) will be provided information about the Financial Reimbursement Program. Patients who enroll to therapeutic cancer clinical trial will be eligible for the reimbursement program and offered an opportunity to participate in this study.', 'armGroupLabels': ['Survey / Interview Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David E Gerber, MD', 'role': 'CONTACT'}, {'name': 'Rebecca Renn', 'role': 'CONTACT', 'email': 'Rebecca.Renn@utsouthwestern.edu', 'phone': '214-648-7097'}], 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'Rebecca Renn', 'role': 'CONTACT', 'email': 'Rebecca.Renn@utsouthwestern.edu', 'phone': '214-648-7097'}], 'overallOfficials': [{'name': 'David E Gerber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancer Prevention Research Institute of Texas', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Internal Medicine', 'investigatorFullName': 'David E Gerber', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}