Cancer Clinical Trials Financial Reimbursement Program

NCT05402033 | Recruiting DMC

• 1 other identifier: STU-2021-1144
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Clinical Trials

Outcome Measures

Primary Outcomes (6)

• 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.

Study Arms (1)

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

Interventions

Survey / Interview Group BEHAVIORAL

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.

Survey / Interview Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Be enrolled in a therapeutic cancer clinical trial
• Speak English or Spanish

You may not qualify if:

• Not enrolled in a clinical trial
• Does not speak English or Spanish

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Cancer Prevention Research Institute of Texas: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires; Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• David E Gerber, MD

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Renn

CONTACT

214-648-7097; Rebecca.Renn@utsouthwestern.edu

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Internal Medicine

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 2, 2022
• Study Start: July 12, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)