Clinical trial NCT06430840: Addressing Financial and Social Needs Among Patients With Cancer
Official title: Addressing Financial and Social Needs Among Patients With Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Financial Hardship
Keywords: Sleep
Cancer
Financial Hardship
financial education
financial navigation
cost communication
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Chao Family Comprehensive Cancer Center
First posted: 2024-05-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Patients' Cost-Related Cancer Care Non-Adherence
timeFrame: Within 6-months after randomization
Secondary outcomes:
measure: Patients' Treatment Completion
timeFrame: Within 6-months after randomization
measure: Patients' Missed Appointments
timeFrame: Within 6-months after randomization
measure: Patients' Material Financial Hardship
timeFrame: Within 6-months after randomization
measure: Patients' Financial Worry
timeFrame: Within 6-months after randomization
measure: Patients' Insurance Literacy
timeFrame: Within 6-months after randomization
measure: Patients' quality of life
timeFrame: Within 6-months after randomization
measure: Patients' Sleep Quality (Subjective)
timeFrame: Within 6-months after randomization
measure: Patients Sleep Quality (Objective)
timeFrame: Within 6-months after randomization
Other outcomes:
measure: Patients' experience with intervention
timeFrame: 6-8 months after randomization
Locations:
city: Costa Mesa
country: United States
facility: UCI Health Cancer Center - Newport
state: California
city: Fountain Valley
country: United States
facility: UCI Health Chao Family Comprehensive Cancer Center - Fountain Valley
state: California
city: Irvine
country: United States
facility: CHAO Family Comprehensive Cancer Center- Irvine
state: California
city: Laguna Hills
country: United States
facility: UCI Health Chao Family Comprehensive Cancer Center - Laguna Hills
state: California
city: Orange
country: United States
facility: UCI Chao Family Comprehensive Cancer Center
state: California
city: Yorba Linda
country: United States
facility: UCI Health - Yorba Linda
state: California
Study officials:
affiliation: University of California, Irvine
name: Gelareh Sadigh
role: PRINCIPAL_INVESTIGATOR
References: