Cancer Clinical Trials
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALSurvey / 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.
Sponsors
University of Texas Southwestern Medical Center
Cancer Prevention Research Institute of Texas
Parkland Health and Hospital System
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical trial enrollment retention rate measured by COST PROM | 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. |
| Clinical trial enrollment retention rate measured by SAHL | 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. |
| Sociodemographic characteristics of the patients measured by COST PROM | 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. |
| Sociodemographic characteristics of the patients measured by SAHL | 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. |
| Characteristics of patients enrolled in a Financial Reimbursement Program who do versus do not submit expense documentation for reimbursement | 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. |
| Identify impact of participation in a Financial Reimbursement Program | Up to first 60 days after enrollment to a therapeutic cancer trial. | Use COST PROM questionnaires to determine factors affecting patient participation decisions . |
Countries
United States
Contacts
CONTACTRebecca Renn
PRINCIPAL_INVESTIGATORDavid E Gerber, MD
Professor
Outcome results
None listed