Cancer Clinical Trials Financial Reimbursement Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Survey / Interview Group.
- Who it may be relevant to
- Registry conditions: Cancer Clinical Trials. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Enhancement of Access to and Diversity in Cancer Clinical Trials Through a Financial Reimbursement and Outreach Program
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Ecologic or community
Study locations
United States · 1 center
- University of Texas Southwestern Medical Center — Dallas
Identifiers
NCT: NCT05402033 · STU-2021-1144