Longitudinal Screening for Financial Hardship to Improve Outcomes in Patients With Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 9
- 主要终点
- Financial Worry
研究概览
简要总结
The study aims to determine whether monthly remote digital financial hardship screening among adults with advanced/metastatic cancer, undergoing outpatient systemic therapy with non-curative intent, improves patient-centered outcomes, including financial worry, health-related quality of life (HRQoL), symptom burden, patient-reported cancer treatment adherence, and exploratory outcomes of overall survival, patient-reported economic burden, patient-reported support received, patient-reported financial coping strategies, and health insurance literacy.
详细描述
Financial hardship is a common problem that affects patients treated for advanced cancer and leads to poor outcomes related to financial worry, health related quality of life (HRQoL), symptom burden, treatment adherence, and overall survival. Prior studies have shown that financial navigation may be an effective strategy to attenuate the impact of financial hardship. However, patients and clinicians have identified communication as a key barrier that prevents patients from being connected to sources of financial assistance. To address this critical gap in patient care, and based on strong preliminary data that financial hardship screening may improve patient outcomes, this financial hardship screening intervention will help connect patients to financial navigation resources. It is hypothesized that by connecting patients experiencing financial hardship with financial navigation resources, this intervention will lead to improved patient-centered outcomes.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum age of 21
- •Understands English and/or Spanish
- •Has a diagnosis of advanced/metastatic cancer
- •Currently undergoing systemic therapy (enteral or parenteral) with non-curative intent
- •Has been receiving treatment for at least 2 months
- •Life expectancy of at least 6 months, in the opinion of the treating oncologist
- •Cognitively able to give informed consent
排除标准
- •Under the age of 21
- •Does not understand English or Spanish
- •Has cognitive deficits that would preclude understanding of consent form and/or questionnaires
- •Undergoing treatment with curative intent (e.g., adjuvant chemotherapy for breast, lung, or ovarian cancer, primary curative therapy for testis cancer or lymphoma)
- •Not undergoing systemic therapy (enteral or parenteral) with non-curative intent
- •Receiving treatment for fewer than 2 months
- •Life expectancy is less than 6 months, in the opinion of the treating oncologist
研究组 & 干预措施
Intervention
Participants randomized to the intervention arm will complete their monthly screening using the single-item screening question (every 4 weeks for 12 months).
干预措施: Financial Hardship Screening (Other)
Enhanced Usual Care
Participants randomized to receive enhanced usual care will not be systematically screened for financial hardship through the electronic PRO Core system.
干预措施: Enhanced Usual Care (Other)
结局指标
主要结局
Financial Worry
时间窗: 6 months
Patient-reported financial worry will be measured by the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for Financial Toxicity (FACIT-COST) total scale. Possible score range: 0 to 44, with higher scores indicating better outcomes
次要结局
- Health-related quality of life(6 months)
- Symptom burden(6 months)
- Cancer treatment adherence(6 months)