Identifying Ideal Reimbursement "Dose" to Reduce Clinical Trial-related Financial Toxicity

Breast Cancer Clinical Trial

Official title: Identifying Ideal Reimbursement "Dose" to Reduce Clinical Trial-related Financial Toxicity

Status Enrolling by invitation

Clinical Trial Summary

The goal of this clinical trial is to identify the recommended financial reimbursement amount for women with breast cancer enrolled in a clinical trial. The main questions it aims to answer are:

1. What is the recommended financial reimbursement amount in trial-enrolled women with breast cancer experiencing financial toxicity?

2. What do patients think about receiving a reimbursement for trial-incurred expenses?

Participants will receive a monthly reimbursement to compensate for their trial-incurred expenses in cohorts, which will de-escalate for the next participant cohort if patients find the reimbursement dose suitable (negative financial toxicity screen, reimbursement dose deemed acceptable/appropriate). Researchers will also use qualitative interviews to explore patient perceptions of the trial reimbursements.

Clinical Trial Description

Our overall objective is to innovatively use a dose-finding approach to identify the recommended reimbursement amount for women with breast cancer enrolled in a clinical trial. We hypothesize that optimal reimbursement for trial-related expenses will decrease patient financial toxicity and increase trial retention. The rationale is that understanding the impact of reimbursement for trial-related costs will aid in addressing socioeconomic barriers to trial participation, thus allowing for more diversity in trial enrollment and ensuring equitable efficacy of cancer treatments when used in real-world clinical settings.

Aim 1. Identify the recommended reimbursement amount in trial-enrolled women with breast cancer experiencing financial toxicity. We propose a pilot reimbursement dose de-escalation trial (continual reassessment method design; N=30) testing a monthly reimbursement for trial-enrolled patients who screen positive for financial toxicity. We will oversample patients who are Black (50%) or residing in rural locations (50%). Monthly patient-reported financial toxicity and reimbursement acceptability and appropriateness will be captured. Reimbursement dose will start at $1000 and de-escalate if patients find the reimbursement dose suitable (negative financial toxicity screen, reimbursement dose deemed acceptable/appropriate).

Aim 2. Explore patient perceptions of trial reimbursement amounts. Using semi-structured interviews, we will explore the effects of reimbursement on specific covered and uncovered trial-related costs, financial toxicity, and current retention and future participation in clinical trials. ;

Related Conditions & MeSH terms

• Breast Cancer
• Financial Stress

• NCT number: NCT05871125
• Study type: Interventional
• Source: University of Alabama at Birmingham
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 1, 2023
• Completion date: April 1, 2026