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

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

The goal of this clinical trial is to explore the feasibility and preliminary impact of a pilot financial reimbursement intervention for women with breast cancer living in the Deep South who are eligible for a clinical trial. The main questions it aims to answer are:

1. Can we recruit and retain patients on a clinical trial to a reimbursement study?
2. What is the preliminary impact of participation in a reimbursement study on patient financial hardship?

Participants will receive a monthly reimbursement to compensate for their trial-incurred expenses. Researchers will use surveys and interviews to explore the impact of receiving reimbursement on trial-related outcomes and financial hardship for participating patients.

This convergent, mixed methods, pilot, feasibility, single-arm trial will provide financial reimbursement to therapeutic clinical trial-eligible women with breast cancer at the University of Alabama at Birmingham. We hypothesize that optimal reimbursement for trial-related expenses is feasible and 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.

Feasibility benchmarks will be defined as 80% retention of consented patients in the reimbursement study and retained patients completing at least 75% of bi-weekly surveys while enrolled. Feasibility will also be assessed by the patient-reported acceptability (as measured by the AIM; scored 1-5, higher scores indicate greater acceptability) and appropriateness (as measured by the IAM; scored 1-5, higher scores indicate greater appropriateness) of the financial reimbursement.

Preliminary impact data will be captured:

1. using bi-weekly surveys that include patient-reported financial toxicity (as measured by the COmprehensive Score for financial Toxicity [COST]), material financial hardship (13 domains, including trouble paying for medical expenses or basic needs), and behavioral financial hardship (12 domains, including postponing or skipping recommended care).
2. using videocall-based semi-structured interview to explore effects of the financial reimbursement on trial recruitment, retention, and financial hardship.

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