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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA013148 | U.S. NIH Grant/Contract | View source | |
| 0 | Other Grant/Funding Number | Community Foundation of Greater Birmingham Women's Breast Health Fund |
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| Name | Class |
|---|---|
| Breast Cancer Research Foundation of Alabama | OTHER |
| Community Foundation of Greater Birmingham Women's Breast Health Fund | UNKNOWN |
| National Cancer Institute (NCI) | NIH |
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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:
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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving reimbursement | Experimental | Monthly reimbursement to offset trial-related expenses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Receive All Reimbursements and Who Complete Follow-up Surveys (Overall Feasibility of Intervention) | 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 | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Courtney Williams, DrPH | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42080701 | Derived | Williams CP, Henderson NL, Jahan N, Stringer-Reasor E, Azuero A, Pisu M, Arend RC, Rocque GB. Financial reimbursement for clinical trial participation costs: a pilot feasibility study. JNCI Cancer Spectr. 2026 May 9;10(3):pkag048. doi: 10.1093/jncics/pkag048. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention: $1,000 Per Month | Cohort 1: Patients receiving reimbursement of $1,000 per month over 4 months, for a total of $4,000 over the course of the intervention. |
| FG001 | Intervention: $900 Per Month | Cohort 2: Patients receiving reimbursement of $900 per month over 4 months, for a total of $3,600 over the course of the intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No cohort met the de-escalation criteria, so all cohorts were dosed at $1,000 per month.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention: Patients Receiving $1,000 Per Month | Receiving reimbursement of $1,000 per month over the course of 4 months, for a total of $4,000 for the intervention. |
| BG001 | Intervention: Patients Receiving $900 Per Month. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Who Receive All Reimbursements and Who Complete Follow-up Surveys (Overall Feasibility of Intervention) | 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 | No cohort met the de-escalation criteria so all cohorts received a $1,000 per month reimbursement. | Posted | Count of Participants | Participants | 2 years |
|
from enrollment until end of follow-up, an average of 6 months
No cohort met the de-escalation criteria, so all cohorts received reimbursement of $1,000 per month.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention: Reimbursement of $1,000 Per Month | Cohort 1: Receiving reimbursement of $1,000 per month over 4 months, for a total of $4,000 over the course of the intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Courtney Williams | University of Alabama at Birmingham | 2059750462 | courtneywilliams@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 26, 2023 | Mar 12, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
Receiving reimbursement of $900 per month over the course of 4 months, for a total of $3,600 for the intervention.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Receiving reimbursement of $900 per month over 4 months, for a total of $3,600 over the course of the intervention |
|
|
| 1 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Intervention: Reimbursement of $900 Per Month | Cohort 2: Receiving reimbursement of $900 per month over 4 months, for a total of $3,600 over the course of the intervention. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D017437 |
| Skin and Connective Tissue Diseases |