Cancer Clinical Trials Financial Reimbursement Program
Purpose
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.
Condition
- Cancer Clinical Trials
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Ecologic or Community
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
Recruiting Locations
Dallas, Texas 75390
David E Gerber, MD
More Details
- NCT ID
- NCT05402033
- Status
- Recruiting
- Sponsor
- University of Texas Southwestern Medical Center
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.