A Pilot Unrestricted Payment Program for Early-stage Cancer Patients: the PAYMENT Trial

Preventing Financial Adversity Among Early-Stage Cancer Patients Through Unrestricted Cash (PAYMENT) Pilot Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Malignant Solid Neoplasm
• Intervention / Treatment: Other: Survey Administration; Other: Interview; Other: Electronic Health Record Review; Other: Support; Other: Support

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ari Bell-Brown; Phone Number: 206-667-7624; Email: abellbro@fredhutch.org

Study Locations

• United States
  • Washington
    • Bellingham, Washington, United States, 98225
      • PeaceHealth Saint Joseph Medical Center
      • Principal Investigator: Rebecca Crompton
    • Vancouver, Washington, United States, 98664
      • PeaceHealth Southwest Medical Center
      • Principal Investigator: Rebecca Crompton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A (high payment schedule); Patients receive a $1000 preloaded cash card once monthly for 3 months.	Other: Survey Administration; Ancillary studies; Other: Interview; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Other: Support; Receive $1000 preloaded cash card; Other Names: Supportive - procedure intent; Other: Support; Receive $100 preloaded cash card; Other Names: Supportive - procedure intent
Active Comparator: Arm B (low payment schedule); Patients receive a $100 preloaded cash card once monthly for 3 months.	Other: Survey Administration; Ancillary studies; Other: Interview; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Other: Support; Receive $1000 preloaded cash card; Other Names: Supportive - procedure intent; Other: Support; Receive $100 preloaded cash card; Other Names: Supportive - procedure intent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI); Oregon Health and Science University; SWOG Cancer Research Network
• Investigators: Principal Investigator: Veena Shankaran, MD, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Patient Care; Health Services; Health Care Facilities Workforce and Services; Interviews as Topic; Palliative Care
• Other Study ID Numbers: RG1124982; UG1CA189974 (U.S. NIH Grant/Contract); NCI-2024-10341 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No