Malignant Solid Neoplasm
Conditions
Brief summary
This clinical trial studies whether an unrestricted cash payment program can be used to improve financial and clinical outcomes in early-stage cancer patients with financial concerns. A cancer diagnosis can have poor financial outcomes, and the cost of cancer treatment can lead to high medical debt and financial hardships for the patient and family. Financial hardship during cancer treatment is associated with adverse outcomes including poorer quality of life, lower treatment compliance, more aggressive use of hospital-based care, and worse survival. Newly diagnosed cancer patients with financial concerns may avoid treatment entirely so that they can continue to work and maintain income, provide for their families, or pay rent. An unrestricted cash payment program provides patients with a preloaded cash card once monthly. The patients can choose what to use the card to pay for and may include items like food, rent, or utilities. This provides a period of guaranteed income for the patients and may prevent them from falling into poverty and improve financial and clinical outcomes.
Detailed description
OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive a $1000 preloaded cash card once monthly for 3 months. ARM B: Patients receive a $100 preloaded cash card once monthly for 3 months. After completion of study intervention, patients are followed up 3 months and 6 months post randomization.
Interventions
OTHERElectronic Health Record Review
Ancillary studies
OTHERInterview
Ancillary studies
OTHERSupport
Receive $1000 preloaded cash card
OTHERSurvey Administration
Ancillary studies
Sponsors
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)
Oregon Health and Science University
SWOG Cancer Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>= 18 * Ability to understand English * Ability to understand and willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants * Within 90 days of a non-metastatic or early-stage solid tumor receiving or rescheduled to receive treatment in the neoadjuvant, adjuvant or definitive setting for curative intent. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 * Current cancer patient at PeaceHealth (Southwest Medical Center or St. Joes) * Not current Medicaid enrollee * Not enrolled in hospice * Screens positive for financial fragility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dropout rate | Up to 1 year | Feasibility will be measured by dropout during study period. The study will be considered feasible to implement if less than 20% of patients drop out. Will be able to estimate a drop-out rate of 20% to within a 95% confidence interval of +/- 18%. |
| Survey completion rate | Up to 1 year | Feasibility will be measure by rates of survey completion. The study will be considered feasible to implement if survey completion is 90% or greater. |
| Participant enrollment | Up to 1 year | Feasibility will be measured by participant enrollment (percent enrolled versus \[vs.\] approached). The study will be considered feasible to implement if 60% or more of approached patients enroll. |
| Time to accrue 20 patients | Up to 1 year | Feasibility will be measured by the time in months to accrue 20 patients. The study will be considered feasible if accrual is reached by 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Financial hardship | Baseline, 3 and 6- months post randomization | Will assess whether patient self-reports one or more of the following: new debt (relative to baseline), income decline of 20% or more, loans from family/friends to pay for cancer treatment, selling/refinancing primary home, \>= 2 months missed rent or mortgage payments, evictions. May adjust either the methods for assessing financial hardship (e.g. using credit reports rather than surveys) or the endpoint itself based on observed survey completion rate and incidence of each endpoint. |
| Treatment nonadherence | Baseline, 3 and 6- months post randomization | Will assess whether patient self reports they did or did not skip medication doses or refuse/decline recommended therapy due to cost concerns. Evidence of treatment completion vs. missed treatments/appointments using data from electronic medical record captured by research assistant. |
| Unplanned emergency department (ED)/hospital admissions | Baseline, 3 and 6- months post randomization | All instances of ED visits and hospital stays (including reason for visit) will be abstracted from patients' medical records. The study team will categorize visits as anticipated (for chemotherapy or planned procedure) vs. unanticipated (complication or treatment side effect). |
| Food and housing insecurity | Baseline, 3 and 6- months post randomization | Will be assessed using items 1 through 4 of the 10-item Health-Related Social Needs Screening Tool from Centers for Medicare and Medicaid Services. |
| Quality of life | Baseline, 3 and 6- months post randomization | Will be assessed using the composite score from the European Quality of Life Five Dimension Index (scored 0-100). A 6-point score change is considered clinically meaningful in United States cancer populations. |
Countries
United States
Contacts
CONTACTAri Bell-Brown
PRINCIPAL_INVESTIGATORVeena Shankaran, MD
Fred Hutch/University of Washington Cancer Consortium
Outcome results
None listed