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

Not Applicable

• Conditions: Breast Cancer
• Interventions: Behavioral: Reimbursement

• Registration Number: NCT05871125
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-05-12
• Study First Submitted QC: 2023-05-12
• Study First Posted: 2023-05-23
• Study Start: 2023-07-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-12-31
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients receiving reimbursement	Reimbursement	Monthly reimbursement to offset trial-related expenses

Primary Outcome Measures

Name	Time	Method
Number of patients who receive all reimbursements and who complete follow-up surveys (overall feasibility of intervention)	2 years	80% retention of patients and retained patients completing at least 75% of surveys while enrolled

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States