Identifying Ideal Reimbursement "Dose" to Reduce Clinical Trial-related Financial Toxicity
NCT ID: NCT05871125
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2023-07-01
2025-12-01
Brief Summary
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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
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Patients receiving reimbursement
Monthly reimbursement to offset trial-related expenses
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Males
* Females without cancer
* Female cancer patients not enrolled in the I-SPY TRIAL 2
18 Years
FEMALE
No
Sponsors
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University of Alabama at Birmingham O'Neal Comprehensive Cancer Center
UNKNOWN
Breast Cancer Research Foundation of Alabama
UNKNOWN
Community Foundation of Greater Birmingham Women's Breast Health Fund
UNKNOWN
University of Alabama at Birmingham
OTHER
Responsible Party
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Courtney Williams
Assistant Professor
Principal Investigators
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Courtney Williams, DrPH
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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Other Identifiers
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0
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IRB-300009554
Identifier Type: -
Identifier Source: org_study_id