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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-10341 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| UG1CA189974 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Oregon Health and Science University | OTHER |
| SWOG Cancer Research Network | NETWORK |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (high payment schedule) | Experimental | Patients receive a $1000 preloaded cash card once monthly for 3 months. |
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| Arm B (low payment schedule) | Active Comparator | Patients receive a $100 preloaded cash card once monthly for 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Health Record Review | Other | Ancillary studies |
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| Measure | Description | Time Frame |
|---|---|---|
| Participant enrollment | 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. | Up to 1 year |
| Time to accrue 20 patients | 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. | Up to 1 year |
| Dropout rate | 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%. | Up to 1 year |
| Survey completion rate | Feasibility will be measure by rates of survey completion. The study will be considered feasible to implement if survey completion is 90% or greater. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Financial hardship | 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. |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ari Bell-Brown | Contact | 206-667-7624 | abellbro@fredhutch.org |
| Name | Affiliation | Role |
|---|---|---|
| Veena Shankaran, MD | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PeaceHealth Saint Joseph Medical Center | Bellingham | Washington | 98225 | United States |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Interview | Other | Ancillary studies |
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| Support | Other | Receive $1000 preloaded cash card |
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| Support | Other | Receive $100 preloaded cash card |
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| Survey Administration | Other | Ancillary studies |
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| Baseline, 3 and 6- months post randomization |
| Treatment nonadherence | 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. | Baseline, 3 and 6- months post randomization |
| Unplanned emergency department (ED)/hospital admissions | 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). | Baseline, 3 and 6- months post randomization |
| Food and housing insecurity | 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. | Baseline, 3 and 6- months post randomization |
| Quality of life | 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. | Baseline, 3 and 6- months post randomization |
| PeaceHealth Southwest Medical Center | Vancouver | Washington | 98664 | United States |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |