Cost Communication and Financial Navigation in Cancer Patients, COSTCOM Trial

Active:	Yes
Cancer Type:	Solid Tumor	NCT ID:	NCT06295367
Trial Phases:		Protocol IDs:	EAQ222CD (primary) EAQ222CD ECOG-ACRIN-EAQ222CD NCI-2023-09944
Eligibility:	0 Years and older, Male and Female	Study Type:	Health services research
Study Sponsor:	ECOG-ACRIN Cancer Research Group
NCI Full Details:	http://clinicaltrials.gov/show/NCT06295367

Summary

This clinical trial evaluates the effect of Cost Communication and Financial Navigation (CostCOM) intervention on adherence to care and financial burden in cancer patients. Many cancer patients experience financial hardship due to high medical out of pocket costs (OOPC), changes in employment, income and insurance. Financial hardship can lead to a delay or a stop in cancer care, and is linked to poor quality of life. Financial navigation programs, such as CostCOM, provide financial counseling, education and connections to appropriate resources to reduce financial barriers to healthcare and minimize financial stress and burden. CostCOM may improve adherence to care and decrease financial burden in patients with cancer.

Objectives

PRIMARY OBJECTIVE:
I. To compare patient-reported cost-related cancer care nonadherence at 12 months after randomization between the enhanced usual care (EUC) and CostCOM study arms.

SECONDARY OBJECTIVES:
I. To compare patient-reported material financial hardship at 12 months after randomization between the EUC and CostCOM study arms.
II. To compare patient-reported financial worry at 12 months after randomization between the EUC and CostCOM study arms.
III. To compare patient-reported quality of life at 12 months after randomization between the EUC and CostCOM study arms.
IV. To compare patient satisfaction with care at 12 months after randomization between the EUC and CostCOM study arms.

EXPLORATORY OBJECTIVES:
I. To describe CostCOM (Arm B) patients and their provider experience with various implementation outcomes.
II. To assess accuracy of out-of-pocket estimates communicated with the CostCOM (Arm B) patients at part of the intervention with their reported actual out-of-pocket cost.
III. To compare neighborhood characteristics of patient participants versus (vs.) practice patient population.
IV. To assess patients’ satisfaction with CostCOM in patients with Arm B.
V. To assess patients’ receipt of financial navigation via internal practice or external resources.
VI. To evaluate longitudinal changes in cost-related cancer care nonadherence, material hardship, financial worry, quality of life and satisfaction with care.

OUTLINE:
Non-patient participants: Participants complete surveys and participate in a 1 on 1 in depth semi-structured interview over 20-30 minutes beginning 15 months after the first patient randomization.

Patients are randomized to 1 of 2 arms.

ARM A: Patients receive Patient Advocate Foundation (PAF) brochure describing financial navigation services.

ARM B: Patients receive usual financial care per practice standard of care and CostCOM financial counseling sessions over 1 hour within 30 days after enrollment and at 3, 6 and 12 months.

Patients in both arms are followed up at 3, 6, and 12 months after study randomization. Additionally, patients in Arm A may be followed up within 18 months after study randomization.

Treatment Sites in Georgia

Nancy N. and J.C. Lewis Cancer Research Pavilion at St. Joseph Candler
225 Candler Drive
Savannah, GA 31405
912-819-5778
www.sjchs.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.