Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430840
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-19
Brief Title:
Addressing Financial and Social Needs Among Patients With Cancer
Sponsor:
University of California Irvine
Organization:
University of California Irvine
Study Overview
Official Title:
Addressing Financial and Social Needs Among Patients With Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAN-ASSIST
Brief Summary:
Financial hardship and health-related social needs eg 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 eg 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 patients 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 4937 | OTHER | University of California Irvine IRB | None |