Breast CancerNCT05871125
Identifying Ideal Reimbursement "Dose" to Reduce Clinical Trial-related Financial Toxicity
A study testing Reimbursement in people with Breast Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Reimbursement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Non-English speakers
- Males
- Females without cancer
- Female cancer patients not enrolled in the I-SPY TRIAL 2
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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:
- Can we recruit and retain patients on a clinical trial to a reimbursement study?
- 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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- Reimbursement
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReimbursementBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving reimbursement | Experimental | Monthly reimbursement to offset trial-related expenses Receives: Behavioral: Reimbursement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start1 Jul 2023
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation of Alabama, Community Foundation of Greater Birmingham Women's Breast Health Fund, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Courtney Williams, University of Alabama at Birmingham
- Investigators
- Courtney Williams, DrPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871125
- Sponsor's protocol ID
- IRB-300009554
- Other IDs
- P30CA013148, 0
- Status last verified
- Apr 2026
- First submitted
- 12 May 2023
- Last updated
- 18 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42080701
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Ideal Reimbursement "Dose" to Reduce Clinical Trial-related Financial Toxicity
- ClinicalTrials.gov ID
- NCT05871125
- Acronym / sponsor ID
- IRB-300009554
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation of Alabama, Community Foundation of Greater Birmingham Women's Breast Health Fund, National Cancer Institute (NCI)
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 23 May 2023 (actual)
- Results
- Posted 18 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can we recruit and retain patients on a clinical trial to a reimbursement study?
- 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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving reimbursement | Experimental | Behavioral: ReimbursementMonthly reimbursement to offset trial-related expenses |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- Non-English speakers
- Males
- Females without cancer
- Female cancer patients not enrolled in the I-SPY TRIAL 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReimbursementPatients 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). | Behavioural | Patients receiving reimbursement |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42080701Williams 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Courtney Williams, DrPH principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reimbursement in people with Breast Cancer, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Who Receive All Reimbursements and Who Complete Follow-up Surveys (Overall Feasibility of Intervention) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05871125, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.