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Effectiveness of Out-of-Pocket Cost COMmunication and Financial Navigation (CostCOM) in Cancer Patients

Award Number: R01CA272680
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/04/2023
PERIOD OF PERFORMANCE END DATE: 12/31/2027

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Effectiveness of Out-of-Pocket Cost COMmunication and Financial Navigation (CostCOM) in Cancer Patients - PROJECT SUMMARY High out-of-pocket costs (OOPC) of cancer treatment and lost income result in financial hardship. There is compelling evidence that OOPC communication complemented by financial navigation and counseling will decrease financial hardship by enabling cancer patients to anticipate and accommodate treatment costs and proactively seek financial assistance. Importantly, this intervention aligns with the Centers for Medicare and Medicaid Services (CMS) price transparency mandate. We will evaluate the effectiveness of an innovative personalized intervention designed to improve cost-related cancer care non-adherence by conducting a randomized controlled trial of OOP cost communication and financial navigation (CostCOM) vs. enhanced usual care (EUC) at NCI Community Oncology Research Program (NCORP) practices. Our multidisciplinary team has experience with all facets of the proposed intervention including conducting clinical trials at NCORP practices. CostCOM comprises four 1-hour counseling sessions to impart: (1) OOPC communication, individualized, patient-specific education of the anticipated OOPC using a price estimator tool; (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. We will recruit 720 patients with newly diagnosed solid tumors (1:1 non-metastatic vs. metastatic) who plan to receive anticancer therapy at one of the participating NCORP practices. CostCOM arm patients will participate in four phone or video sessions with a remote financial counselor at baseline, 3, 6, and 12 months, with all three components of CostCOM delivered at each session. At enrollment, EUC arm patients will receive usual care enhanced by providing an educational brochure describing services and contact information of the Patient Advocate Foundation (PAF), a national non-profit financial navigation organization. Patients will complete surveys at baseline, 3, 6, and 12 months after enrollment. Our goals are to (1) compare the effectiveness of CostCOM vs. EUC at 12 months on patient-reported cost-related cancer care nonadherence, defined as any self-reported incident of delay, forgo, stop or change in cancer care due to cost concerns, as well as (2) patient-reported material financial hardship, financial worry, and quality of life; and (3) conduct a process evaluation to examine practice providers and CostCOM arm patients’ satisfaction with the intervention and their perceptions of barriers and facilitators to CostCOM delivery (for providers) or receipt (for patients). A successful CostCOM is a scalable and financially sustainable program that can be disseminated across systems, conditions, and populations and improve cancer care delivery, patients’ experience, and health outcomes.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $539,143 )
2026	2026	UNIVERSITY OF CALIFORNIA IRVINE	160 ALDRICH HALL	IRVINE	CA	92697	ORANGE	USA	Cancer Cause and Prevention Research	000	4	12/23/2025	NON-COMPETING CONTINUATION	$539,143
														Subtotal = $539,143

Issue Date FY: 2025 ( Subtotal = $613,085 )
2025	2025	UNIVERSITY OF CALIFORNIA IRVINE	160 ALDRICH HALL	IRVINE	CA	92697	ORANGE	USA	Cancer Cause and Prevention Research	000	3	12/6/2024	NON-COMPETING CONTINUATION	$551,777
2025	2025	UNIVERSITY OF CALIFORNIA IRVINE	160 ALDRICH HALL	IRVINE	CA	92697	ORANGE	USA	Cancer Cause and Prevention Research	001	3	6/2/2025	NON-COMPETING CONTINUATION	$61,308
														Subtotal = $613,085

Issue Date FY: 2024 ( Subtotal = $554,885 )
2024	2024	UNIVERSITY OF CALIFORNIA IRVINE	160 ALDRICH HALL	IRVINE	CA	92697	ORANGE	USA	Cancer Cause and Prevention Research	001	2	4/16/2024	NON-COMPETING CONTINUATION	$29,204
2024	2024	UNIVERSITY OF CALIFORNIA IRVINE	160 ALDRICH HALL	IRVINE	CA	92697	ORANGE	USA	Cancer Cause and Prevention Research	000	2	1/10/2024	NON-COMPETING CONTINUATION	$525,681
														Subtotal = $554,885

Issue Date FY: 2023 ( Subtotal = $652,687 )
2023	2023	UNIVERSITY OF CALIFORNIA, IRVINE	160 ALDRICH HALL	IRVINE	CA	92697	ORANGE	USA	Cancer Cause and Prevention Research	000	1	1/4/2023	NEW	$652,687
														Subtotal = $652,687

Grand Total All Awards = $2,359,800

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Effectiveness of Out-of-Pocket Cost COMmunication and Financial Navigation (CostCOM) in Cancer Patients

Award Number: R01CA272680

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 01/04/2023

PERIOD OF PERFORMANCE END DATE: 12/31/2027

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