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

Fred Hutchinson Cancer Center20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Malignant Solid Neoplasm

Interventions

Electronic Health Record ReviewOTHER

Ancillary studies

InterviewOTHER

Ancillary studies

SupportOTHER

Receive $1000 preloaded cash card

SupportOTHER

Receive $100 preloaded cash card

Survey AdministrationOTHER

Ancillary studies

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, United States

NOT_YET_RECRUITING

PeaceHealth St. John Medical Center

Longview, Washington, United States

RECRUITING

PeaceHealth Southwest Medical Center

Vancouver, Washington, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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%.

Time frame: 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.

Time frame: Up to 1 year

Secondary Outcomes

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.