Cancer Clinical Trials Financial Reimbursement Program

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Enhancement of Access to and Diversity in Cancer Clinical Trials Through a Financial Reimbursement and Outreach Program

Conditions
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Cancer Clinical Trials

Intervention / Treatment
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* Behavioral: Survey / Interview Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be enrolled in a therapeutic cancer clinical trial Speak English or Spanish Exclusion Criteria: Not enrolled in a clinical trial Does not speak English or Spanish

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Survey / Interview Group<br>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. | Behavioral: Survey / Interview Group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical trial enrollment retention rate measured by COST PROM | 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. | Up to first 60 days after enrollment to a therapeutic cancer trial. | 
| Clinical trial enrollment retention rate measured by SAHL | 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. | Up to first 60 days after enrollment to a therapeutic cancer trial. | 
| Sociodemographic characteristics of the patients measured by COST PROM | 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. | Up to first 60 days after enrollment to a therapeutic cancer trial. | 
| Sociodemographic characteristics of the patients measured by SAHL | 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. | Up to first 60 days after enrollment to a therapeutic cancer trial. | 
| Characteristics of patients enrolled in a Financial Reimbursement Program who do versus do not submit expense documentation for reimbursement | 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. | Up to first 60 days after enrollment to a therapeutic cancer trial. | 
| Identify impact of participation in a Financial Reimbursement Program | Use COST PROM questionnaires to determine factors affecting patient participation decisions . | Up to first 60 days after enrollment to a therapeutic cancer trial. |