Cancer Clinical Trials Financial Reimbursement Program

Enhancement of Access to and Diversity in Cancer Clinical Trials Through a Financial Reimbursement and Outreach 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.

Study Overview

• Status: Recruiting
• Conditions: Cancer Clinical Trials
• Intervention / Treatment: Behavioral: Survey / Interview Group

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.

• Study Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Marieshia Hicks; Phone Number: 214-648-7577; Email: Marieshia.Hicks@UTSouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas Southwestern Medical Center
      • Contact: David E Gerber, MD
      • Contact: Marieshia Hicks; Email: Marieshia.Hicks@UTSouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from among patients seen in the cancer clinics of the Harold C. Simmons Comprehensive Cancer Center, including those at UT Southwestern Medical Center, Parkland Health and Hospital System, and Children's Health. Patients with any cancer type who are informed that they are eligible for participation in any phase therapeutic cancer clinical trial by their treating physician (generally a medical oncologist) will be offered the opportunity to determine if they are interested in and eligible for the Financial Reimbursement Program and this Research Study to evaluate the Program.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Behavioral: Survey / 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Cancer Prevention Research Institute of Texas
• Investigators: Principal Investigator: David E Gerber, MD, professor

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: STU-2021-1144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No