Breast Cancer
Conditions
Brief 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. Can we recruit and retain patients on a clinical trial to a reimbursement study? 2. 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: 1. 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). 2. using videocall-based semi-structured interview to explore effects of the financial reimbursement on trial recruitment, retention, and financial hardship.
Interventions
BEHAVIORALReimbursement
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).
Sponsors
University of Alabama at Birmingham
Breast Cancer Research Foundation of Alabama
Community Foundation of Greater Birmingham Women's Breast Health Fund
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Receive All Reimbursements and Who Complete Follow-up Surveys (Overall Feasibility of Intervention) | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCourtney Williams, DrPH
University of Alabama at Birmingham
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 52 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 33 | 0 / 0 |
| other Total, other adverse events | 0 / 33 | 0 / 0 |
| serious Total, serious adverse events | 0 / 33 | 0 / 0 |
Outcome results
None listed