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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
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
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Ari Bell-Brown
- Phone Number: 206-667-7624
- Email: abellbro@fredhutch.org
Study Locations
-
-
Washington
-
Bellingham, Washington, United States, 98225
- Not yet recruiting
- PeaceHealth Saint Joseph Medical Center
-
Principal Investigator:
- Kara Makin-Bond, RN, CCRP
-
Longview, Washington, United States, 98632
- Recruiting
- PeaceHealth St. John Medical Center
-
Principal Investigator:
- Kara Makin-Bond, RN, CCRP
-
Vancouver, Washington, United States, 98664
- Recruiting
- PeaceHealth Southwest Medical Center
-
Principal Investigator:
- Kara Makin-Bond, RN, CCRP
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Arm A (high payment schedule)
Patients receive a $1000 preloaded cash card once monthly for 3 months.
|
Ancillary studies
Ancillary studies
Ancillary studies
Receive $1000 preloaded cash card
Other Names:
Receive $100 preloaded cash card
Other Names:
|
|
Active Comparator: Arm B (low payment schedule)
Patients receive a $100 preloaded cash card once monthly for 3 months.
|
Ancillary studies
Ancillary studies
Ancillary studies
Receive $1000 preloaded cash card
Other Names:
Receive $100 preloaded cash card
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant enrollment
Time Frame: 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.
|
Up to 1 year
|
|
Time to accrue 20 patients
Time Frame: 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.
|
Up to 1 year
|
|
Dropout rate
Time Frame: 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%.
|
Up to 1 year
|
|
Survey completion rate
Time Frame: 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.
|
Up to 1 year
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Financial hardship
Time Frame: 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.
|
Baseline, 3 and 6- months post randomization
|
|
Treatment nonadherence
Time Frame: 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.
|
Baseline, 3 and 6- months post randomization
|
|
Unplanned emergency department (ED)/hospital admissions
Time Frame: 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).
|
Baseline, 3 and 6- months post randomization
|
|
Food and housing insecurity
Time Frame: 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.
|
Baseline, 3 and 6- months post randomization
|
|
Quality of life
Time Frame: 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.
|
Baseline, 3 and 6- months post randomization
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Veena Shankaran, MD, Fred Hutch/University of Washington Cancer Consortium
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
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
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.