Enhancement of Access to and Diversity in Cancer Clinical Trials Through a Financial Reimbursement and Outreach Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Clinical trial enrollment retention rate measured by SAHL
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be enrolled in a therapeutic cancer clinical trial
- •Speak English or Spanish
排除标准
- •Not enrolled in a clinical trial
- •Does not speak English or Spanish
研究组 & 干预措施
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.
干预措施: Survey / Interview Group (Behavioral)
结局指标
主要结局
Clinical trial enrollment retention rate measured by SAHL
时间窗: 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
时间窗: 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.
Characteristics of patients enrolled in a Financial Reimbursement Program who do versus do not submit expense documentation for reimbursement
时间窗: 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.
Sociodemographic characteristics of the patients measured by SAHL
时间窗: 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.
Identify impact of participation in a Financial Reimbursement Program
时间窗: Up to first 60 days after enrollment to a therapeutic cancer trial.
Use COST PROM questionnaires to determine factors affecting patient participation decisions .
Clinical trial enrollment retention rate measured by COST PROM
时间窗: 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.
次要结局
未报告次要终点
研究者
David E Gerber
Professor, Internal Medicine
University of Texas Southwestern Medical Center