Clinical trial NCT05402033: Cancer Clinical Trials Financial Reimbursement Program
Official title: Enhancement of Access to and Diversity in Cancer Clinical Trials Through a Financial Reimbursement and Outreach Program
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer Clinical Trials
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Cancer Prevention Research Institute of Texas
First posted: 2022-06-02
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical trial enrollment retention rate measured by COST PROM
timeFrame: Up to first 60 days after enrollment to a therapeutic cancer trial.
measure: Clinical trial enrollment retention rate measured by SAHL
timeFrame: Up to first 60 days after enrollment to a therapeutic cancer trial.
measure: Sociodemographic characteristics of the patients measured by COST PROM
timeFrame: Up to first 60 days after enrollment to a therapeutic cancer trial.
measure: Sociodemographic characteristics of the patients measured by SAHL
timeFrame: Up to first 60 days after enrollment to a therapeutic cancer trial.
measure: Characteristics of patients enrolled in a Financial Reimbursement Program who do versus do not submit expense documentation for reimbursement
timeFrame: Up to first 60 days after enrollment to a therapeutic cancer trial.
measure: Identify impact of participation in a Financial Reimbursement Program
timeFrame: Up to first 60 days after enrollment to a therapeutic cancer trial.
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: Professor
name: David E Gerber, MD
role: PRINCIPAL_INVESTIGATOR
References: