Recruiting

Observational Study

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT05402033

Conditions

Cancer Clinical Trials

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Survey / Interview Group

Study Details

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

Study ID

NCT05402033

Start date

Jul 12, 2022

Status verified date

Aug, 2026

Completion date

Jun 1, 2030

Anticipated

Primary completion date

Jun 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

1200 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Clinical trial enrollment retention rate measured by COST PROM [ Time Frame: Up to first 60 days after enrollment to a therapeutic cancer trial. ]
  • Clinical trial enrollment retention rate measured by SAHL [ Time Frame: Up to first 60 days after enrollment to a therapeutic cancer trial. ]
  • Sociodemographic characteristics of the patients measured by COST PROM [ Time Frame: Up to first 60 days after enrollment to a therapeutic cancer trial. ]
  • Sociodemographic characteristics of the patients measured by SAHL [ Time Frame: 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 [ Time Frame: Up to first 60 days after enrollment to a therapeutic cancer trial. ]
  • Identify impact of participation in a Financial Reimbursement Program [ Time Frame: Up to first 60 days after enrollment to a therapeutic cancer trial. ]

Central Contacts and Locations

Central contacts

Rebecca Renn

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

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Rebecca Renn

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

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-09-02.