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NCT05871125 | Enrolling by invitation | Breast Cancer


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

University of Alabama at Birmingham

Information provided by (Responsible Party):

Courtney Williams

Brief Summary:

The goal of this clinical trial is to identify the recommended financial reimbursement amount for women with breast cancer enrolled in a clinical trial. The main questions it aims to answer are: What is the recommended financial reimbursement amount in trial-enrolled women with breast cancer experiencing financial toxicity? 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.

Condition or disease

Breast Cancer

Intervention/treatment

Reimbursement

Phase

Not Applicable

Detailed Description:

Our overall objective is to innovatively use a dose-finding approach to identify the recommended reimbursement amount for women with breast cancer enrolled in a clinical trial. We hypothesize that optimal reimbursement for trial-related expenses 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. 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.}}

Study Type : Interventional
Estimated Enrollment : 30 participants
Masking : None (Open Label)
Primary Purpose : Health Services Research
Official Title : Identifying Ideal Reimbursement "Dose" to Reduce Clinical Trial-related Financial Toxicity
Actual Study Start Date : July 1, 2023
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : April 1, 2026
Arm Intervention/treatment

Experimental: Patients receiving reimbursement

Monthly reimbursement to offset trial-related expenses

Behavioral: Reimbursement

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Criteria
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

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

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

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Locations


Not yet recruiting

United States, Alabama

University of Alabama at Birmingham

Birmingham, alabama, United States, 35294

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