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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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:

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).
using videocall-based semi-structured interview to explore effects of the financial reimbursement on trial recruitment, retention, and financial hardship.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reimbursement

Behavioral

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).

Primary outcomes

Number of Patients Who Receive All Reimbursements and Who Complete Follow-up Surveys (Overall Feasibility of Intervention)

Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

Breast Cancer Research Foundation of Alabama
Community Foundation of Greater Birmingham Women's Breast Health Fund
National Cancer Institute (NCI)

Registry information

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: May 23, 2023
Registry last updated: May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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