Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Costa Mesa, California and other locations
Dates
study started
completion around
Principal Investigator
by Gelareh Sadigh

Description

Summary

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.

Details

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.

Keywords

Cancer, Financial Hardship, Sleep, financial education, financial navigation, cost communication, Financial Stress, Provision of local and national resources to address financial and social needs, Screening for financial and social needs, CostCOM, FinEd

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Locations

  • UCI Health Cancer Center - Newport
    Costa Mesa California 92627 United States
  • UCI Chao Family Comprehensive Cancer Center
    Orange California 92868 United States
  • UCI Health - Yorba Linda
    Yorba Linda California 92886 United States

Lead Scientist at UC Irvine

  • Gelareh Sadigh
    Associate Professor In Residence, Radiological Sciences, School of Medicine. Authored (or co-authored) 107 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT06430840
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated