Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
Study NCT ID:
NCT06295367
Status:
RECRUITING
Last Update Posted:
2025-11-13
First Post:
2024-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cost Communication and Financial Navigation in Cancer Patients (COSTCOM)
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Study Overview
Official Title:
Effectiveness of Out-of-Pocket Cost COMmunication and Financial Navigation (CostCOM) in Cancer Patients
Status:
RECRUITING
Status Verified Date:
2025-11
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:
None
Brief 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.
Detailed Description:
PRIMARY OBJECTIVE:
I. To compare patient-reported cost-related cancer care non-adherence at 12 months after completion of baseline survey between the enhanced usual care (EUC) and CostCOM study arms.
SECONDARY OBJECTIVES:
I. To compare patient-reported material financial hardship at 12 months after completion of baseline survey between the EUC and CostCOM study arms.
II. To compare patient-reported financial worry at 12 months after completion of baseline survey between the EUC and CostCOM study arms.
III. To compare patient-reported quality of life at 12 months after completion of baseline survey between the EUC and CostCOM study arms.
IV. To compare patient satisfaction with care at 12 months after completion of baseline survey 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 non-adherence, material hardship, financial worry, quality of life and satisfaction with care.
OUTLINE:
Non-patient participants: Participants complete surveys and participant in 1 on 1 in depth semi-structured interview over 20-30 minutes at 15-39 months after first patient enrollment.
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 are followed up within 12 months of study intervention completion.
I. To compare patient-reported cost-related cancer care non-adherence at 12 months after completion of baseline survey between the enhanced usual care (EUC) and CostCOM study arms.
SECONDARY OBJECTIVES:
I. To compare patient-reported material financial hardship at 12 months after completion of baseline survey between the EUC and CostCOM study arms.
II. To compare patient-reported financial worry at 12 months after completion of baseline survey between the EUC and CostCOM study arms.
III. To compare patient-reported quality of life at 12 months after completion of baseline survey between the EUC and CostCOM study arms.
IV. To compare patient satisfaction with care at 12 months after completion of baseline survey 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 non-adherence, material hardship, financial worry, quality of life and satisfaction with care.
OUTLINE:
Non-patient participants: Participants complete surveys and participant in 1 on 1 in depth semi-structured interview over 20-30 minutes at 15-39 months after first patient enrollment.
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 are followed up within 12 months of study intervention completion.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2023-09944 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| EAQ222CD | OTHER | ECOG-ACRIN Cancer Research Group | View | |
| ECOG-ACRIN-EAQ222CD | OTHER | DCP | View | |
| EAQ222CD | OTHER | CTEP | View | |
| R01CA272680 | NIH | None | https://reporter.nih.gov/quic… | View |
| UG1CA189828 | NIH | None | https://reporter.nih.gov/quic… | View |