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

NAActive, not recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

July 1, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

April 1, 2026

Conditions
Breast Cancer
Interventions
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).

Trial Locations (1)

35294

University of Alabama at Birmingham, Birmingham

All Listed Sponsors
lead

University of Alabama at Birmingham

OTHER