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

The University of Alabama at Birmingham

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Reimbursement

Study type: Interventional

Funder types: Other

Identifiers

NCT05871125

0

IRB-300009554

P30CA013148 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants will be women with breast cancer currently enrolled in the Investigation of Serial studies to Predict Your Therapeutic Response with Imaging and Molecular AnaLysis (I-SPY TRIAL 2) at the UAB Medical Oncology Clinic.

Exclusion criteria

• Non-English speakers
• Males
• Females without cancer
• Female cancer patients not enrolled in the I-SPY TRIAL 2

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Patients receiving reimbursement

Experimental group

Description:

Monthly reimbursement to offset trial-related expenses

Treatment:

Behavioral: Reimbursement