Preventing Financial Adversity Among Early-Stage Cancer Patients Through Unrestricted Cash (PAYMENT) Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- Participant enrollment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Arm B (low payment schedule)
Patients receive a $100 preloaded cash card once monthly for 3 months.
干预措施: Interview (Other)
Arm B (low payment schedule)
Patients receive a $100 preloaded cash card once monthly for 3 months.
干预措施: Survey Administration (Other)
Arm A (high payment schedule)
Patients receive a $1000 preloaded cash card once monthly for 3 months.
干预措施: Interview (Other)
Arm A (high payment schedule)
Patients receive a $1000 preloaded cash card once monthly for 3 months.
干预措施: Support (Other)
Arm A (high payment schedule)
Patients receive a $1000 preloaded cash card once monthly for 3 months.
干预措施: Survey Administration (Other)
Arm B (low payment schedule)
Patients receive a $100 preloaded cash card once monthly for 3 months.
干预措施: Electronic Health Record Review (Other)
Arm A (high payment schedule)
Patients receive a $1000 preloaded cash card once monthly for 3 months.
干预措施: Electronic Health Record Review (Other)
Arm B (low payment schedule)
Patients receive a $100 preloaded cash card once monthly for 3 months.
干预措施: Support (Other)
结局指标
主要结局
Participant enrollment
时间窗: 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.
Time to accrue 20 patients
时间窗: 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.
Dropout rate
时间窗: 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%.
Survey completion rate
时间窗: 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.
次要结局
- Financial hardship(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)
- Treatment nonadherence(Baseline, 3 and 6- months post randomization)
- Quality of life(Baseline, 3 and 6- months post randomization)