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

NCT06771739 | Not Yet Recruiting

• 3 other identifiers: RG1124982NCI-2024-10341UG1CA189974
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Financial hardship

  Baseline, 3 and 6- months post randomization

• Treatment nonadherence

  Baseline, 3 and 6- months post randomization

• Unplanned emergency department (ED)/hospital admissions

  Baseline, 3 and 6- months post randomization

• Food and housing insecurity

  Baseline, 3 and 6- months post randomization

• Quality of life

  Baseline, 3 and 6- months post randomization

Study Arms (2)

Arm A (high payment schedule)

EXPERIMENTAL

Patients receive a $1000 preloaded cash card once monthly for 3 months.

Other: Electronic Health Record Review; Other: Interview; Other: Support; Other: Survey Administration

Arm B (low payment schedule)

ACTIVE COMPARATOR

Patients receive a $100 preloaded cash card once monthly for 3 months.

Other: Electronic Health Record Review; Other: Interview; Other: Support; Other: Survey Administration

Interventions

Interview OTHER

Ancillary studies

Arm A (high payment schedule); Arm B (low payment schedule)

Electronic Health Record Review OTHER

Ancillary studies

Arm A (high payment schedule); Arm B (low payment schedule)

Support OTHER

Receive $1000 preloaded cash card

Also known as: Supportive - procedure intent

Arm A (high payment schedule)

Survey Administration OTHER

Ancillary studies

Arm A (high payment schedule); Arm B (low payment schedule)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Oregon Health and Science University: collaborator
• SWOG Cancer Research Network: collaborator

Study Sites (2)

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, 98225, United States

Location

PeaceHealth Southwest Medical Center

Vancouver, Washington, 98664, United States

Location

MeSH Terms

Interventions

Interviews as Topic; Palliative Care

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Veena Shankaran, MD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ari Bell-Brown

CONTACT

206-667-7624; abellbro@fredhutch.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 13, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 13, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)