Identifying Ideal Reimbursement "Dose" to Reduce Clinical Trial-related Financial Toxicity
Primary Purpose
Breast Cancer
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reimbursement
Sponsored by
About this trial
This is an interventional health services research trial for Breast Cancer
Eligibility 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
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients receiving reimbursement
Arm Description
Monthly reimbursement to offset trial-related expenses
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05871125
First Posted
May 12, 2023
Last Updated
July 6, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT05871125
Brief Title
Identifying Ideal Reimbursement "Dose" to Reduce Clinical Trial-related Financial Toxicity
Official Title
Identifying Ideal Reimbursement "Dose" to Reduce Clinical Trial-related Financial Toxicity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
April 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients receiving reimbursement
Arm Type
Experimental
Arm Description
Monthly reimbursement to offset trial-related expenses
Intervention Type
Behavioral
Intervention Name(s)
Reimbursement
Intervention Description
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 Outcome Measure Information:
Title
Number of patients who receive all reimbursements and who complete follow-up surveys (overall feasibility of intervention)
Description
80% retention of patients and retained patients completing at least 75% of surveys while enrolled
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Courtney Williams, DrPH
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Identifying Ideal Reimbursement "Dose" to Reduce Clinical Trial-related Financial Toxicity
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