跳至主要内容
临床试验/NCT06430840
NCT06430840进行中(未招募)不适用

Addressing Financial and Social Needs Among Patients With Cancer

University of California, Irvine6 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2024年8月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
91
试验地点
6
主要终点
Patients' Cost-Related Cancer Care Non-Adherence

研究概览

简要总结

Financial hardship and health-related social needs (e.g., insecurity about food, housing, transportation, utilities) are common among patients with cancer, resulting in health disparities in cancer outcomes. Our study will test the efficacy of a multicomponent financial navigation and counseling program delivered by a financial navigator (CostCOM), vs. direct patient access to financial education materials and comprehensive list of local resources in the absence of a financial navigator (FinEd) vs. practice usual care among newly diagnosed cancer patients who screen positive for financial hardship and social needs. Investigators anticipate that both CostCOM and FinEd compared to enhanced usual care will improve cost-related cancer care nonadherence, financial worry, health insurance literacy, quality of life and sleep quality and decrease number of missed appointments.

详细描述

Financial hardship and health-related social needs (HRSNs) (e.g., insecurity about food, housing, transportation, and utilities) are common among patients with cancer, resulting in health disparities in cancer outcomes. Addressing financial hardship and HRSNs can mitigate their damaging health effects, yet screening for them is not the standard clinical practice. There is compelling evidence that out-of-pocket cost (OOPC) communication complemented by financial navigation and counseling delivered by a financial navigator (CostCOM intervention) will decrease financial hardship. However, implementation of this intervention is limited given shortage of financial navigators in many cancer centers. There is also evidence that patients with financial hardship have lower financial health literacy and financial self-efficacy. However, it is not clear whether direct access to local community or national resources and financial education (FinEd intervention) in the absence of financial navigators will meet patient's needs. Investigators propose a 3-arm pilot randomized controlled trial to assess potential efficacy differences in adherence, financial hardship, financial health literacy, quality of life, and sleep between CostCOM vs. FinEd vs. enhanced usual care (EUC) among 90 newly diagnosed cancer patients (1:1 non-metastatic vs. metastatic) who receive systemic or radiation therapy and are screened positive for financial and social needs. Our multidisciplinary team has experience with all facets of the proposed intervention. CostCOM patients will participate in two remote counseling sessions at baseline, and 3 months, and will receive (1) OOPC communication, individualized, patient-specific education of the anticipated medication OOPC; (2) Financial navigation, real-time professional guidance to identify financial assistance programs that will alleviate costs of care and discuss information to improve insurance coverage; and (3) Financial counseling to address the range of patients' financial concerns and enroll patients in financial assistance programs. FinEd patients will receive (1) a comprehensive list of local and national resources where patients can self-refer for financial and social needs; and (2) online and paper financial educational materials on topics such as health insurance and health insurance literacy, and navigating price estimator tools. EUC patients will receive usual care enhanced by screening for financial and social needs. Our goals are to compare the efficacy of CostCOM vs. FinEd vs. EUC at 6 months on (1) patient-reported cost-related cancer care nonadherence (defined as self-reported delay, forgo, stop or change in cancer care due to cost concerns), treatment completion and missed appointments (as obtained via medical record); (2) patient-reported financial worry, material hardship, health insurance literacy, and quality of life; and (3) patient-reported and objectively measured sleep quality using a sleep monitor. The study will support feasibility for a larger trial, and reveal efficacy estimates for potential CostCOM vs. FinEd differences in improving cancer patients' outcomes and approaches for incorporation into routine clinical practice.

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
Single (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

入选标准

  • Speak English or Spanish
  • 18 years or older
  • Were diagnosed with any stage of cancer within the last 120 days
  • Getting treatment in University of California Irvine-affiliated oncology clinics
  • Have already started treatment like radiation, or cancer medication
  • Screen positive for financial hardship or health-related social needs

排除标准

  • Patients with indolent cancer undergoing observation alone
  • Eastern Cooperative Oncology Group (ECOG) Performance status above 2
  • Patients not receiving any cancer-directed therapy
  • Patients participating in other therapeutic clinical trials covering the cost of treatment.

研究组 & 干预措施

Arm A: Enhanced Usual Care (EUC)

Active Comparator

Usual care + pre-screening for financial hardship and social risks

干预措施: Usual care (Other)

Arm B: CostCOM

Experimental

Usual care + two 1-hour phone or video sessions with a remote financial counselor including out-of-pocket cost communication, financial navigation and counseling.

干预措施: Usual care (Other)

Arm A: Enhanced Usual Care (EUC)

Active Comparator

Usual care + pre-screening for financial hardship and social risks

干预措施: Screening for financial and social needs (Other)

Arm B: CostCOM

Experimental

Usual care + two 1-hour phone or video sessions with a remote financial counselor including out-of-pocket cost communication, financial navigation and counseling.

干预措施: CostCOM (Cost Communication, Financial navigation and counseling) (Behavioral)

Arm B: CostCOM

Experimental

Usual care + two 1-hour phone or video sessions with a remote financial counselor including out-of-pocket cost communication, financial navigation and counseling.

干预措施: Screening for financial and social needs (Other)

Arm C: FinEd

Experimental

Usual care + access to local and national resources including (1) a detailed list of local and national resources for financial navigation, and social needs where patients can self-refer and (2) video and online /printed educational materials to improve financial health literacy

干预措施: Provision of local and national resources to address financial and social needs (Behavioral)

Arm C: FinEd

Experimental

Usual care + access to local and national resources including (1) a detailed list of local and national resources for financial navigation, and social needs where patients can self-refer and (2) video and online /printed educational materials to improve financial health literacy

干预措施: Financial Education (Behavioral)

Arm C: FinEd

Experimental

Usual care + access to local and national resources including (1) a detailed list of local and national resources for financial navigation, and social needs where patients can self-refer and (2) video and online /printed educational materials to improve financial health literacy

干预措施: Usual care (Other)

Arm C: FinEd

Experimental

Usual care + access to local and national resources including (1) a detailed list of local and national resources for financial navigation, and social needs where patients can self-refer and (2) video and online /printed educational materials to improve financial health literacy

干预措施: Screening for financial and social needs (Other)

结局指标

主要结局

Patients' Cost-Related Cancer Care Non-Adherence

时间窗: Within 6-months after randomization

Number of patients who report any incidence during the 6 months (measured at 3, and 6 months) when they self-reports a positive response to any of: (1) delay, (2) forego, (3) stop, or (4) change in cancer prescribed medication due to cost, (5) refuse recommended cancer tests, or (6) skip cancer office visits due to cost.

次要结局

  • Patients' Financial Worry(Within 6-months after randomization)
  • Patients' Treatment Completion(Within 6-months after randomization)
  • Patients' Missed Appointments(Within 6-months after randomization)
  • Patients' Insurance Literacy(Within 6-months after randomization)
  • Patients' Material Financial Hardship(Within 6-months after randomization)
  • Patients' Sleep Quality (Subjective)(Within 6-months after randomization)
  • Patients Sleep Quality (Objective)(Within 6-months after randomization)
  • Patients' quality of life(Within 6-months after randomization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gelareh Sadigh

Associate Professor In Residence

University of California, Irvine

研究点 (6)

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