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Identifying Ideal Reimbursement "Dose" to Reduce Clinical Trial-related Financial Toxicity
Sponsor: University of Alabama at Birmingham
Summary
The goal of this clinical trial is to explore the feasibility and preliminary impact of a pilot financial reimbursement intervention for women with breast cancer living in the Deep South who are eligible for a clinical trial. The main questions it aims to answer are: 1. Can we recruit and retain patients on a clinical trial to a reimbursement study? 2. What is the preliminary impact of participation in a reimbursement study on patient financial hardship? Participants will receive a monthly reimbursement to compensate for their trial-incurred expenses. Researchers will use surveys and interviews to explore the impact of receiving reimbursement on trial-related outcomes and financial hardship for participating patients.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
39
Start Date
2023-07-01
Completion Date
2025-12-01
Last Updated
2026-05-18
Healthy Volunteers
No
Conditions
Interventions
Reimbursement
Patients will be dosed in cohorts of 5, with a maximum available sample size of 30. The first cohort of 5 patients will be enrolled at the first reimbursement dose level of $1000 per month for 4 months ($4000 per patient in total). At the end of the 4-month period, reimbursement dose suitability will be determined as suitable by a cumulative negative financial toxicity screen and reimbursement dose deemed acceptable and appropriate in at least 4 patients. If the reimbursement dose is found suitable, we will de-escalate the reimbursement dose for the next cohort of 5 patients. If the reimbursement dose is found unsuitable, the next cohort of 5 patients will be enrolled at the same reimbursement amount ($1000 per month for 4 months).
Locations (1)
University of Alabama at Birmingham
Birmingham, Alabama, United States