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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
39
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).
University of Alabama at Birmingham
Birmingham, Alabama, United States
Number of Patients Who Receive All Reimbursements and Who Complete Follow-up Surveys (Overall Feasibility of Intervention)
Number of patients who receive all reimbursements: 80% retention of patients Number of retained patients who patients who complete surveys: 75% of survey completion while enrolled
Time frame: 2 years
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