University of Alabama at Birmingham
Courtney Williams
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.
Breast Cancer
Reimbursement
NA
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 30 participants |
| Masking : | NONE |
| Primary Purpose : | HEALTH_SERVICES_RESEARCH |
| Official Title : | Identifying Ideal Reimbursement "Dose" to Reduce Clinical Trial-related Financial Toxicity |
| Actual Study Start Date : | 2023-07-01 |
| Estimated Primary Completion Date : | 2025-12-31 |
| Estimated Study Completion Date : | 2026-04-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | FEMALE |
| Accepts Healthy Volunteers: |
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Not yet recruiting
University of Alabama at Birmingham
Birmingham, Albama, United States, 35294