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

NCT05871125 | Completed

• 3 other identifiers: IRB-300009554P30CA0131480
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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:

1. 1.What is the recommended financial reimbursement amount in trial-enrolled women with breast cancer experiencing financial toxicity?
2. 2.What do patients think about receiving a reimbursement for trial-incurred expenses?

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of patients who receive all reimbursements and who complete follow-up surveys (overall feasibility of intervention)

  80% retention of patients and retained patients completing at least 75% of surveys while enrolled

  2 years

Study Arms (1)

Patients receiving reimbursement

EXPERIMENTAL

Monthly reimbursement to offset trial-related expenses

Behavioral: Reimbursement

Interventions

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).

Patients receiving reimbursement

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Non-English speakers
• Males
• Females without cancer
• Female cancer patients not enrolled in the I-SPY TRIAL 2

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Breast Cancer Research Foundation of Alabama: collaborator
• Community Foundation of Greater Birmingham Women's Breast Health Fund: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Courtney Williams, DrPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 23, 2023
• Study Start: July 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)