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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05871125
• Other study ID #: IRB-300009554
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: April 1, 2026

Study information

• Verified date: July 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: April 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Financial Stress

Intervention

Behavioral:
• 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

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who receive all reimbursements and who complete follow-up surveys (overall feasibility of intervention)	80% retention of patients and retained patients completing at least 75% of surveys while enrolled	2 years