Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1200 participants
OBSERVATIONAL
2022-07-12
2027-06-01
Brief Summary
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Detailed Description
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The 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.
Statistical 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.
Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Study Groups
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Survey / Interview Group
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.
Baseline assessment consisting of sociodemographic items and study eligibility questions (call #1)
In 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.
Survey / Interview Group
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.
Interventions
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Survey / Interview Group
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.
Eligibility Criteria
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Inclusion Criteria
* Speak English or Spanish
Exclusion Criteria
* Does not speak English or Spanish
ALL
No
Sponsors
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Cancer Prevention Research Institute of Texas
OTHER
University of Texas Southwestern Medical Center
OTHER
Responsible Party
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David E Gerber
Professor, Internal Medicine
Principal Investigators
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David E Gerber, MD
Role: PRINCIPAL_INVESTIGATOR
Professor
Locations
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University of Texas Southwestern Medical Center
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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David E Gerber, MD
Role: primary
Other Identifiers
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STU-2021-1144
Identifier Type: -
Identifier Source: org_study_id
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