University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Location status: Recruiting
Recruiting
NCT Number: NCT05402033
Cancer Clinical Trials Financial Reimbursement Program
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Survey / Interview Group
BehavioralPatients 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.
Primary outcomes
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Clinical trial enrollment retention rate measured by COST PROM
Time frame: Up to first 60 days after enrollment to a therapeutic cancer trial.
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.
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Clinical trial enrollment retention rate measured by SAHL
Time frame: Up to first 60 days after enrollment to a therapeutic cancer trial.
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.
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Sociodemographic characteristics of the patients measured by COST PROM
Time frame: Up to first 60 days after enrollment to a therapeutic cancer trial.
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.
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Sociodemographic characteristics of the patients measured by SAHL
Time frame: Up to first 60 days after enrollment to a therapeutic cancer trial.
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.
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Characteristics of patients enrolled in a Financial Reimbursement Program who do versus do not submit expense documentation for reimbursement
Time frame: Up to first 60 days after enrollment to a therapeutic cancer trial.
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.
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Identify impact of participation in a Financial Reimbursement Program
Time frame: Up to first 60 days after enrollment to a therapeutic cancer trial.
Use COST PROM questionnaires to determine factors affecting patient participation decisions .
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Texas Southwestern Medical Center
Other
Collaborators
- Cancer Prevention Research Institute of Texas
Registry information
Official study title
Enhancement of Access to and Diversity in Cancer Clinical Trials Through a Financial Reimbursement and Outreach Program
Important dates
- Study start
- 2022
- Primary completion
- 2029
- Study completion
- 2030
- First posted
- Jun 2, 2022
- Registry last updated
- Jul 20, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.