CAFÉ: Clinic Based Intervention to Address Financial Hardship for People With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 371
- 试验地点
- 1
- 主要终点
- Financial distress
研究概览
简要总结
This study is a randomized clinical trial designed to test a novel financial navigation intervention. The study assesses the impact of the financial navigation intervention on financial hardship and health-related quality of life, cancer-related material and psychological financial hardship, patient-centered communication, and time to initiation of treatment.
详细描述
Rationale:
Up to half of people with cancer experience financial hardship. Cancer-related financial hardship is associated with several adverse intermediate and health outcomes, including poor quality of life, treatment non-adherence, and lower survival.
Observational evidence suggests that communication about financial concerns and out-of-pocket (OOP) costs early in the treatment trajectory and in partnership with the care team could help to prevent or lessen financial hardship. This type of communication could be delivered through patient navigation programs and is consistent with both patient and care team preferences.
However, to date there is no evidence from randomized trials showing the impact of financial navigation during the active treatment on financial hardship. Further, no intervention-based studies have provided evidence on the most effective ways to mitigate cancer-related financial hardship.
Background:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •KPNW and KPWA members with a new cancer diagnosis (within the past 120 days from identification date)
- •18+ years of age (based on age at time of identification date)
- •Recent visit to CAFÉ clinic/department
- •Current, living member as of identification date
- •Continuous enrollment at least 6 months prior to identification date
- •English speaker for KPWA; English or Spanish speaker for KPNW
排除标准
- •On do-not contact list at KP
- •Cancer diagnosis is for non-melanoma skin cancer
- •Cancer diagnosis is for a benign or in situ tumor
- •Hospice referral in past year
- •Self or household member has already enrolled or completed participation in CAFÉ pilot study or main trial.
- •Unable to complete survey
研究组 & 干预措施
Arm 1: Enhanced usual care
Participants in this arm will receive their usual care plus a Financial Resource Sheet. The financial resource sheet lists and describes existing organization and community resources available to KP members.
干预措施: Enhanced usual care (Behavioral)
Arm 2: Brief financial navigation intervention
Participants in this arm will receive their usual care, and the Financial Resource Sheet described in Arm 1, plus one (1) cycle of financial navigation (total cycles: 1; total length: 6 months). In each intervention cycle participants will get at least one (1) phone call with a CAFÉ Financial Navigator, the navigator will talk with participants to identify financial questions or concerns. The navigator will create a personalized plan for each participant. Participants can request extra support from the navigator for up to 6 months.
干预措施: Financial navigation (Behavioral)
Arm 3: Extended financial navigation intervention
Participants in this arm will receive their usual care, a Financial Resource Sheet and the brief intervention described in Arm 2 (i.e., one (1) cycle of financial navigation). Plus, they will receive two (2) additional cycles of financial navigation (total cycles: 3; total length: 6 months).
干预措施: Financial navigation (Behavioral)
结局指标
主要结局
Financial distress
时间窗: baseline and 12 months
InCharge Financial Distress/Financial Well-Being Scale. This is a validated, 8-item scale that assesses current ability to meet financial obligations, stress or worry about finances, and satisfaction with present financial situation. It is scored to a 10-point scale, where 1 is "Overwhelming financial distress/lowest financial well-being," and 10 is "No financial distress/highest financial well-being." It has been validated in multiple populations and national norms are provided.
Health-related quality of life (cancer specific)
时间窗: baseline and 12 months
The FACT-G7 is a 7-item version of the Functional Assessment of Cancer Therapy-General (FACT-G), a patient-reported outcome measure used to assess health-related quality of life in patients undergoing cancer therapy. The survey assesses the impacts of cancer therapy in four domains: physical, social/family, emotional, and functional. Higher scores represent higher quality of life.
次要结局
- Financial hardship due to cancer care costs(baseline and 12 months)