The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
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
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.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
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
Name: Gelareh Sadigh
Affiliation: ECOG-ACRIN Cancer Research Group
Role: PRINCIPAL_INVESTIGATOR