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Spots Global Cancer Trial Database for Cost Communication and Financial Navigation in Cancer Patients (COSTCOM)

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Trial Identification

Brief Title: Cost Communication and Financial Navigation in Cancer Patients (COSTCOM)

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

Study ID: NCT06295367

Study Description

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.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

Mercy Hospital Fort Smith, Fort Smith, Arkansas, United States

CARTI Cancer Center, Little Rock, Arkansas, United States

Saint Anthony's Health, Alton, Illinois, United States

Saint Mary's Hospital, Centralia, Illinois, United States

Good Samaritan Regional Health Center, Mount Vernon, Illinois, United States

Central Care Cancer Center - Garden City, Garden City, Kansas, United States

Central Care Cancer Center - Great Bend, Great Bend, Kansas, United States

Saint Louis Cancer and Breast Institute-Ballwin, Ballwin, Missouri, United States

Central Care Cancer Center - Bolivar, Bolivar, Missouri, United States

Cox Cancer Center Branson, Branson, Missouri, United States

Freeman Health System, Joplin, Missouri, United States

Mercy Hospital Joplin, Joplin, Missouri, United States

Lake Regional Hospital, Osage Beach, Missouri, United States

Delbert Day Cancer Institute at PCRMC, Rolla, Missouri, United States

Mercy Clinic-Rolla-Cancer and Hematology, Rolla, Missouri, United States

Heartland Regional Medical Center, Saint Joseph, Missouri, United States

Saint Louis Cancer and Breast Institute-South City, Saint Louis, Missouri, United States

Mercy Hospital South, Saint Louis, Missouri, United States

Mercy Hospital Saint Louis, Saint Louis, Missouri, United States

Mercy Hospital Springfield, Springfield, Missouri, United States

CoxHealth South Hospital, Springfield, Missouri, United States

Mercy Hospital Washington, Washington, Missouri, United States

Strecker Cancer Center-Belpre, Belpre, Ohio, United States

Adena Regional Medical Center, Chillicothe, Ohio, United States

Mount Carmel East Hospital, Columbus, Ohio, United States

The Mark H Zangmeister Center, Columbus, Ohio, United States

Mount Carmel Health Center West, Columbus, Ohio, United States

Central Ohio Breast and Endocrine Surgery, Gahanna, Ohio, United States

Mount Carmel Grove City Hospital, Grove City, Ohio, United States

Zangmeister Center Grove City, Grove City, Ohio, United States

Fairfield Medical Center, Lancaster, Ohio, United States

Saint Rita's Medical Center, Lima, Ohio, United States

Marietta Memorial Hospital, Marietta, Ohio, United States

Memorial Hospital, Marysville, Ohio, United States

Knox Community Hospital, Mount Vernon, Ohio, United States

Mount Carmel New Albany Surgical Hospital, New Albany, Ohio, United States

Licking Memorial Hospital, Newark, Ohio, United States

Newark Radiation Oncology, Newark, Ohio, United States

Mercy Health Perrysburg Cancer Center, Perrysburg, Ohio, United States

Southern Ohio Medical Center, Portsmouth, Ohio, United States

Springfield Regional Cancer Center, Springfield, Ohio, United States

Springfield Regional Medical Center, Springfield, Ohio, United States

Saint Vincent Mercy Medical Center, Toledo, Ohio, United States

Mercy Health - Saint Anne Hospital, Toledo, Ohio, United States

Saint Ann's Hospital, Westerville, Ohio, United States

Clinton Memorial Hospital, Wilmington, Ohio, United States

Genesis Healthcare System Cancer Care Center, Zanesville, Ohio, United States

Mercy Hospital Oklahoma City, Oklahoma City, Oklahoma, United States

Contact Details

Name: Gelareh Sadigh

Affiliation: ECOG-ACRIN Cancer Research Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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