Cost Communication and Financial Navigation in Cancer Patients (COSTCOM)

September 2, 2026 updated by: ECOG-ACRIN Cancer Research Group

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

760

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Guam
      • Tamuning, Guam, 96913
        • FHP Health Center-Guam
  • Puerto Rico
      • Bayamón, Puerto Rico, 00959-5060
        • Cancer Center-Metro Medical Center Bayamon
      • Bayamón, Puerto Rico, 00961
        • Puerto Rico Hematology Oncology Group
      • Manati, Puerto Rico, 00674
        • Doctors Cancer Center
      • San Juan, Puerto Rico, 00917
        • San Juan Community Oncology Group
      • San Juan, Puerto Rico, 00927
        • Centro Comprensivo de Cancer de UPR
      • San Juan, Puerto Rico, 00936
        • San Juan City Hospital
      • San Juan, Puerto Rico, 00927
        • PROncology
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 98508
        • Anchorage Associates in Radiation Medicine
      • Anchorage, Alaska, United States, 99508
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, United States, 99508
        • Alaska Oncology and Hematology LLC
      • Anchorage, Alaska, United States, 99508
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, United States, 99508
        • Katmai Oncology Group
      • Anchorage, Alaska, United States, 99508
        • Providence Alaska Medical Center
      • Fairbanks, Alaska, United States, 99701
        • Fairbanks Memorial Hospital
    • Arizona
      • Kingman, Arizona, United States, 86401
        • Kingman Regional Medical Center
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Mercy Hospital Fort Smith
      • Jonesboro, Arkansas, United States, 72401
        • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
      • Little Rock, Arkansas, United States, 72205
        • CARTI Cancer Center
    • California
      • Arroyo Grande, California, United States, 93420
        • PCR Oncology
      • Burbank, California, United States, 91505
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Martinez, California, United States, 94553-3156
        • Contra Costa Regional Medical Center
      • Napa, California, United States, 94558
        • Providence Queen of The Valley
      • Santa Rosa, California, United States, 95403
        • Providence Medical Foundation - Santa Rosa
      • Santa Rosa, California, United States, 95405
        • Providence Santa Rosa Memorial Hospital
      • Walnut Creek, California, United States, 94598
        • BASS Medical Group - Lennon
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Centers-Aurora
      • Boulder, Colorado, United States, 80303
        • Boulder Community Foothills Hospital
      • Boulder, Colorado, United States, 80304
        • Rocky Mountain Cancer Centers-Boulder
      • Centennial, Colorado, United States, 80112
        • Rocky Mountain Cancer Centers - Centennial
      • Denver, Colorado, United States, 80218
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers-Midtown
      • Denver, Colorado, United States, 80220
        • Rocky Mountain Cancer Centers-Rose
      • Denver, Colorado, United States, 80218
        • Colorado Blood Cancer Institute
      • Denver, Colorado, United States, 80209
        • The Women's Imaging Center
      • Englewood, Colorado, United States, 80113
        • Mountain Blue Cancer Care Center - Swedish
      • Englewood, Colorado, United States, 80113
        • Rocky Mountain Cancer Centers - Swedish
      • Englewood, Colorado, United States, 80113
        • The Melanoma and Skin Cancer Institute
      • Lakewood, Colorado, United States, 80228
        • Rocky Mountain Cancer Centers-Lakewood
      • Littleton, Colorado, United States, 80120
        • Rocky Mountain Cancer Centers-Littleton
      • Lone Tree, Colorado, United States, 80124
        • Rocky Mountain Cancer Centers-Sky Ridge
      • Longmont, Colorado, United States, 80501
        • Rocky Mountain Cancer Centers-Longmont
      • Thornton, Colorado, United States, 80260
        • Rocky Mountain Cancer Centers-Thornton
    • Georgia
      • Hinesville, Georgia, United States, 31313
        • Liberty County Cancer Care
      • Savannah, Georgia, United States, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, United States, 96817
        • The Cancer Center of Hawaii-Liliha
      • Honolulu, Hawaii, United States, 96813
        • Hawaii Cancer Care Inc - Waterfront Plaza
      • Honolulu, Hawaii, United States, 96813
        • Queen's Cancer Cenrer - POB I
      • Honolulu, Hawaii, United States, 96813
        • Straub Clinic and Hospital
      • Honolulu, Hawaii, United States, 96813
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, United States, 96817
        • Kuakini Medical Center
      • Honolulu, Hawaii, United States, 96817
        • Queen's Cancer Center - Kuakini
      • Honolulu, Hawaii, United States, 96826
        • Kapiolani Medical Center for Women and Children
      • Honolulu, Hawaii, United States, 96859
        • Tripler Army Medical Center
      • Honolulu, Hawaii, United States, 96817
        • Hawaii Diagnostic Radiology Services LLC
      • Kahului, Hawaii, United States, 96732
        • Straub Medical Center - Kahului Clinic
      • Kailua, Hawaii, United States, 96734
        • Castle Medical Center
      • Lihue, Hawaii, United States, 96766
        • Wilcox Memorial Hospital and Kauai Medical Clinic
      • ‘Aiea, Hawaii, United States, 96701
        • Hawaii Cancer Care - Westridge
      • ‘Aiea, Hawaii, United States, 96701
        • Pali Momi Medical Center
      • ‘Aiea, Hawaii, United States, 96701
        • Queen's Cancer Center - Pearlridge
      • ‘Aiea, Hawaii, United States, 96701
        • The Cancer Center of Hawaii-Pali Momi
      • ‘Ewa Beach, Hawaii, United States, 96706
        • The Queen's Medical Center - West Oahu
    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Boise, Idaho, United States, 83712
        • Saint Luke's Cancer Institute - Boise
      • Caldwell, Idaho, United States, 83605
        • Saint Alphonsus Cancer Care Center-Caldwell
      • Coeur d'Alene, Idaho, United States, 83814
        • Kootenai Health - Coeur d'Alene
      • Fruitland, Idaho, United States, 83619
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, United States, 83642
        • Idaho Urologic Institute-Meridian
      • Meridian, Idaho, United States, 83642
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, United States, 83687
        • Saint Alphonsus Cancer Care Center-Nampa
      • Nampa, Idaho, United States, 83687
        • Saint Luke's Cancer Institute - Nampa
      • Post Falls, Idaho, United States, 83854
        • Kootenai Clinic Cancer Services - Post Falls
      • Sandpoint, Idaho, United States, 83864
        • Kootenai Clinic Cancer Services - Sandpoint
      • Twin Falls, Idaho, United States, 83301
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Alton, Illinois, United States, 62002
        • OSF Saint Anthony's Health Center
      • Bloomington, Illinois, United States, 61704
        • Illinois CancerCare-Bloomington
      • Canton, Illinois, United States, 61520
        • Illinois CancerCare-Canton
      • Carbondale, Illinois, United States, 62902
        • Memorial Hospital of Carbondale
      • Carterville, Illinois, United States, 62918
        • SIH Cancer Institute
      • Carthage, Illinois, United States, 62321
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, United States, 62801
        • Centralia Oncology Clinic
      • Centralia, Illinois, United States, 62801
        • Saint Mary's Hospital
      • Danville, Illinois, United States, 61832
        • Carle at The Riverfront
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Dixon, Illinois, United States, 61021
        • Illinois CancerCare-Dixon
      • Effingham, Illinois, United States, 62401
        • Crossroads Cancer Center
      • Effingham, Illinois, United States, 62401
        • Carle Physician Group-Effingham
      • Eureka, Illinois, United States, 61530
        • Illinois CancerCare-Eureka
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare-Galesburg
      • Kewanee, Illinois, United States, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Macomb, Illinois, United States, 61455
        • Illinois CancerCare-Macomb
      • Mattoon, Illinois, United States, 61938
        • Carle Physician Group-Mattoon/Charleston
      • Mount Vernon, Illinois, United States, 62864
        • SSM Health Good Samaritan
      • Normal, Illinois, United States, 61761
        • Carle Cancer Institute Normal
      • Normal, Illinois, United States, 61761
        • Carle BroMenn Medical Center
      • O'Fallon, Illinois, United States, 62269
        • Cancer Care Center of O'Fallon
      • O'Fallon, Illinois, United States, 62269
        • HSHS Saint Elizabeth's Hospital
      • Ottawa, Illinois, United States, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Pekin, Illinois, United States, 61554
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, United States, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare-Peoria
      • Peru, Illinois, United States, 61354
        • Illinois CancerCare-Peru
      • Peru, Illinois, United States, 61354
        • Valley Radiation Oncology
      • Princeton, Illinois, United States, 61356
        • Illinois CancerCare-Princeton
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, United States, 62702
        • Springfield Clinic
      • Springfield, Illinois, United States, 62781
        • Springfield Memorial Hospital
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
      • Washington, Illinois, United States, 61571
        • Illinois CancerCare - Washington
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403
        • Mercy Hospital
      • Cedar Rapids, Iowa, United States, 52403
        • Oncology Associates at Mercy Medical Center
    • Kansas
      • Fairway, Kansas, United States, 66205
        • University of Kansas Clinical Research Center
      • Garden City, Kansas, United States, 67846
        • Central Care Cancer Center - Garden City
      • Great Bend, Kansas, United States, 67530
        • Central Care Cancer Center - Great Bend
      • Hays, Kansas, United States, 67601
        • HaysMed
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Cancer Center
      • Lawrence, Kansas, United States, 66044
        • Lawrence Memorial Hospital
      • Olathe, Kansas, United States, 66061
        • The University of Kansas Cancer Center - Olathe
      • Overland Park, Kansas, United States, 66210
        • University of Kansas Cancer Center-Overland Park
      • Overland Park, Kansas, United States, 66211
        • University of Kansas Hospital-Indian Creek Campus
      • Pittsburg, Kansas, United States, 66762
        • Mercy Hospital Pittsburg
      • Salina, Kansas, United States, 67401
        • Salina Regional Health Center
      • Topeka, Kansas, United States, 66606
        • University of Kansas Health System Saint Francis Campus
      • Westwood, Kansas, United States, 66205
        • University of Kansas Hospital-Westwood Cancer Center
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • Mercy Health - Paducah Cancer Center
    • Michigan
      • Battle Creek, Michigan, United States, 49017
        • Bronson Battle Creek
      • Grand Rapids, Michigan, United States, 49503
        • Trinity Health Grand Rapids Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
      • Iron Mountain, Michigan, United States, 49801
        • Dickinson County Healthcare System
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, United States, 49009
        • Beacon Kalamazoo Cancer Center
      • Kalamazoo, Michigan, United States, 49048
        • Beacon Kalamazoo
      • Muskegon, Michigan, United States, 49444
        • Trinity Health Muskegon Hospital
      • Niles, Michigan, United States, 49120
        • Corewell Health Lakeland Hospitals - Niles Hospital
      • Norton Shores, Michigan, United States, 49444
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
      • Reed City, Michigan, United States, 49677
        • Corewell Health Reed City Hospital
      • Saint Joseph, Michigan, United States, 49085
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
      • Saint Joseph, Michigan, United States, 49085
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
      • Wyoming, Michigan, United States, 49519
        • University of Michigan Health - West
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Minnesota Oncology - Burnsville
      • Cambridge, Minnesota, United States, 55008
        • Cambridge Medical Center
      • Chaska, Minnesota, United States, 55318
        • Minnesota Oncology Hematology PA-Chaska
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Minnesota Oncology - Coon Rapids
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Edina, Minnesota, United States, 55435
        • Minnesota Oncology - Edina
      • Maple Grove, Minnesota, United States, 55369
        • Fairview Clinics and Surgery Center Maple Grove
      • Maple Grove, Minnesota, United States, 55369
        • Minnesota Oncology - Maple Grove
      • Maplewood, Minnesota, United States, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, United States, 55454
        • Health Partners Inc
      • Monticello, Minnesota, United States, 55362
        • Monticello Cancer Center
      • New Ulm, Minnesota, United States, 56073
        • New Ulm Medical Center
      • Princeton, Minnesota, United States, 55371
        • Fairview Northland Medical Center
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Medical Health Center
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Shakopee, Minnesota, United States, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, United States, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, United States, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology PA-Woodbury
      • Wyoming, Minnesota, United States, 55092
        • Fairview Lakes Medical Center
    • Mississippi
      • Columbus, Mississippi, United States, 39705
        • Baptist Memorial Hospital and Cancer Center-Golden Triangle
      • Grenada, Mississippi, United States, 38901
        • Baptist Cancer Center-Grenada
      • Jackson, Mississippi, United States, 39202
        • Jackson Oncology Associates PLLC
      • Jackson, Mississippi, United States, 39202
        • Mississippi Baptist Medical Center
      • New Albany, Mississippi, United States, 38652
        • Baptist Memorial Hospital and Cancer Center-Union County
      • Oxford, Mississippi, United States, 38655
        • Baptist Memorial Hospital and Cancer Center-Oxford
      • Southhaven, Mississippi, United States, 38671
        • Baptist Memorial Hospital and Cancer Center-Desoto
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Mercy Oncology and Hematology - Clayton-Clarkson
      • Bolivar, Missouri, United States, 65613
        • Central Care Cancer Center - Bolivar
      • Branson, Missouri, United States, 65616
        • Cox Cancer Center Branson
      • Cape Girardeau, Missouri, United States, 63703
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, United States, 63703
        • Mercy Cancer Center - Cape Girardeau
      • Farmington, Missouri, United States, 63640
        • Parkland Health Center - Farmington
      • Joplin, Missouri, United States, 64804
        • Freeman Health System
      • Joplin, Missouri, United States, 64804
        • Mercy Hospital Joplin
      • Kansas City, Missouri, United States, 64154
        • University of Kansas Cancer Center - North
      • Kansas City, Missouri, United States, 64108
        • University Health Truman Medical Center
      • Kansas City, Missouri, United States, 64116
        • University of Kansas Cancer Center - Briarcliff
      • Lee's Summit, Missouri, United States, 64064
        • University of Kansas Cancer Center - Lee's Summit
      • Osage Beach, Missouri, United States, 65065
        • Lake Regional Hospital
      • Rolla, Missouri, United States, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Rolla, Missouri, United States, 65401
        • Phelps Health Delbert Day Cancer Institute
      • Saint Joseph, Missouri, United States, 64506
        • Heartland Regional Medical Center
      • Sainte Genevieve, Missouri, United States, 63670
        • Sainte Genevieve County Memorial Hospital
      • Springfield, Missouri, United States, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
      • St Louis, Missouri, United States, 63109
        • Mercy Infusion Center - Chippewa
      • St Louis, Missouri, United States, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, United States, 63128
        • Mercy Hospital South
      • Sullivan, Missouri, United States, 63080
        • Missouri Baptist Sullivan Hospital
      • Washington, Missouri, United States, 63090
        • Mercy Hospital Washington
    • Montana
      • Anaconda, Montana, United States, 59711
        • Community Hospital of Anaconda
      • Billings, Montana, United States, 59101
        • Billings Clinic Cancer Center
      • Bozeman, Montana, United States, 59715
        • Bozeman Health Deaconess Hospital
      • Great Falls, Montana, United States, 59405
        • Great Falls Clinic
      • Great Falls, Montana, United States, 59405
        • Benefis Sletten Cancer Institute
      • Havre, Montana, United States, 59501
        • Hi-Line Sletten Cancer Center
      • Helena, Montana, United States, 59601
        • Benefis Helena Specialty Center
      • Kalispell, Montana, United States, 59901
        • Logan Health Medical Center
      • Missoula, Montana, United States, 59802
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, United States, 59804
        • Community Medical Center
    • Nevada
      • Carson City, Nevada, United States, 89703
        • Carson Tahoe Regional Medical Center
      • Henderson, Nevada, United States, 89052
        • Comprehensive Cancer Centers of Nevada - Henderson
      • Henderson, Nevada, United States, 89052
        • Cancer and Blood Specialists-Henderson
      • Henderson, Nevada, United States, 89074
        • Comprehensive Cancer Centers of Nevada-Southeast Henderson
      • Henderson, Nevada, United States, 89052
        • Comprehensive Cancer Centers of Nevada-Horizon Ridge
      • Henderson, Nevada, United States, 89074
        • Las Vegas Urology - Green Valley
      • Henderson, Nevada, United States, 89074
        • Las Vegas Urology - Pebble
      • Henderson, Nevada, United States, 89074
        • Urology Specialists of Nevada - Green Valley
      • Henderson, Nevada, United States, 89074
        • Oncology Las Vegas - Henderson
      • Las Vegas, Nevada, United States, 89144
        • Summerlin Hospital Medical Center
      • Las Vegas, Nevada, United States, 89109
        • Sunrise Hospital and Medical Center
      • Las Vegas, Nevada, United States, 89102
        • OptumCare Cancer Care at Charleston
      • Las Vegas, Nevada, United States, 89106
        • Radiation Oncology Centers of Nevada Central
      • Las Vegas, Nevada, United States, 89119
        • Radiation Oncology Centers of Nevada Southeast
      • Las Vegas, Nevada, United States, 89128
        • Comprehensive Cancer Centers of Nevada - Northwest
      • Las Vegas, Nevada, United States, 89128
        • OptumCare Cancer Care at MountainView
      • Las Vegas, Nevada, United States, 89135
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
      • Las Vegas, Nevada, United States, 89144
        • Comprehensive Cancer Centers of Nevada - Town Center
      • Las Vegas, Nevada, United States, 89144
        • Comprehensive Cancer Centers of Nevada-Summerlin
      • Las Vegas, Nevada, United States, 89148
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada - Central Valley
      • Las Vegas, Nevada, United States, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, United States, 89128
        • Ann M Wierman MD LTD
      • Las Vegas, Nevada, United States, 89074
        • Las Vegas Urology - Pecos
      • Las Vegas, Nevada, United States, 89103
        • Hope Cancer Care of Nevada
      • Las Vegas, Nevada, United States, 89106
        • Urology Specialists of Nevada - Central
      • Las Vegas, Nevada, United States, 89113
        • Las Vegas Prostate Cancer Center
      • Las Vegas, Nevada, United States, 89113
        • Las Vegas Urology - Sunset
      • Las Vegas, Nevada, United States, 89128
        • Las Vegas Urology - Cathedral Rock
      • Las Vegas, Nevada, United States, 89128
        • Las Vegas Urology - Smoke Ranch
      • Las Vegas, Nevada, United States, 89128
        • Urology Specialists of Nevada - Northwest
      • Las Vegas, Nevada, United States, 89169
        • University Cancer Center
      • Las Vegas, Nevada, United States, 89113
        • Urology Specialists of Nevada - Southwest
      • Las Vegas, Nevada, United States, 89128
        • Oncology Las Vegas - Tenaya
      • Las Vegas, Nevada, United States, 89183
        • OptumCare Cancer Care at Fort Apache
      • Pahrump, Nevada, United States, 89048
        • Hope Cancer Care of Nevada-Pahrump
      • Reno, Nevada, United States, 89502
        • Renown Regional Medical Center
      • Reno, Nevada, United States, 89503
        • Saint Mary's Regional Medical Center
      • Reno, Nevada, United States, 89509
        • Radiation Oncology Associates
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • CentraState Medical Center
      • Hackettstown, New Jersey, United States, 07840
        • Hackettstown Medical Center
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center
      • Newton, New Jersey, United States, 07860
        • Newton Medical Center
      • Pompton, New Jersey, United States, 07444
        • Chilton Medical Center
      • Summit, New Jersey, United States, 07902
        • Overlook Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Lovelace Medical Center-Saint Joseph Square
      • Albuquerque, New Mexico, United States, 87109
        • Lovelace Radiation Oncology
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Cancer Center
      • Albuquerque, New Mexico, United States, 87109
        • Lovelace Women's Hospital
    • New York
      • The Bronx, New York, United States, 10461
        • Montefiore Medical Center-Einstein Campus
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center - Moses Campus
    • North Carolina
      • Asheboro, North Carolina, United States, 27203
        • Cone Health Cancer Center at Asheboro
      • Asheboro, North Carolina, United States, 27205
        • Cone Health MedCenter Asheboro
      • Asheville, North Carolina, United States, 28803
        • AdventHealth Infusion Center Asheville
      • Burlington, North Carolina, United States, 27215
        • Cone Health Cancer Center at Alamance Regional
      • Clyde, North Carolina, United States, 28721
        • AdventHealth Infusion Center Haywood
      • Greensboro, North Carolina, United States, 27403
        • Cone Health Cancer Center
      • Greensboro, North Carolina, United States, 27410
        • Cone Health Cancer Center at Drawbridge Parkway
      • Hendersonville, North Carolina, United States, 28792
        • AdventHealth Hendersonville
      • Reidsville, North Carolina, United States, 27320
        • Annie Penn Memorial Hospital
      • Weaverville, North Carolina, United States, 28787
        • AdventHealth Infusion Center Weaverville
    • Ohio
      • Belpre, Ohio, United States, 45714
        • Strecker Cancer Center-Belpre
      • Chillicothe, Ohio, United States, 45601
        • Adena Regional Medical Center
      • Columbus, Ohio, United States, 43219
        • The Mark H Zangmeister Center
      • Columbus, Ohio, United States, 43213
        • Mount Carmel East Hospital
      • Columbus, Ohio, United States, 43222
        • Mount Carmel Health Center West
      • Gahanna, Ohio, United States, 43230
        • Central Ohio Breast and Endocrine Surgery
      • Grove City, Ohio, United States, 43123
        • Mount Carmel Grove City Hospital
      • Grove City, Ohio, United States, 43123
        • Zangmeister Center Grove City
      • Lancaster, Ohio, United States, 43130
        • Fairfield Medical Center
      • Lima, Ohio, United States, 45801
        • Saint Rita's Medical Center
      • Marietta, Ohio, United States, 45750
        • Marietta Memorial Hospital
      • Marysville, Ohio, United States, 43040
        • Memorial Hospital
      • Mount Vernon, Ohio, United States, 43050
        • Knox Community Hospital
      • New Albany, Ohio, United States, 43054
        • Mount Carmel New Albany Surgical Hospital
      • Newark, Ohio, United States, 43055
        • Licking Memorial Hospital
      • Newark, Ohio, United States, 43055
        • Newark Radiation Oncology
      • Perrysburg, Ohio, United States, 43551
        • Mercy Health - Perrysburg Hospital
      • Portsmouth, Ohio, United States, 45662
        • Southern Ohio Medical Center
      • Springfield, Ohio, United States, 45504
        • Springfield Regional Cancer Center
      • Springfield, Ohio, United States, 45504
        • Springfield Regional Medical Center
      • Toledo, Ohio, United States, 43623
        • Mercy Health - Saint Anne Hospital
      • Toledo, Ohio, United States, 43608
        • Mercy Health - Saint Vincent Hospital
      • Toledo, Ohio, United States, 43623
        • Mercy Health Sylvania Radiation Oncology Center
      • Westerville, Ohio, United States, 43081
        • Saint Ann's Hospital
      • Wilmington, Ohio, United States, 45177
        • Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center
      • Zanesville, Ohio, United States, 43701
        • Genesis Healthcare System Cancer Care Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Mercy Hospital Oklahoma City
    • Oregon
      • Baker City, Oregon, United States, 97814
        • Saint Alphonsus Cancer Care Center-Baker City
      • Bend, Oregon, United States, 97701
        • Saint Charles Health System
      • Clackamas, Oregon, United States, 97015
        • Clackamas Radiation Oncology Center
      • Coos Bay, Oregon, United States, 97420
        • Bay Area Hospital
      • Hood River, Oregon, United States, 97031
        • Providence Hood River Memorial Hospital
      • Newberg, Oregon, United States, 97132
        • Providence Newberg Medical Center
      • Ontario, Oregon, United States, 97914
        • Saint Alphonsus Cancer Care Center-Ontario
      • Oregon City, Oregon, United States, 97045
        • Providence Willamette Falls Medical Center
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • Providence Saint Vincent Medical Center
      • Redmond, Oregon, United States, 97756
        • Saint Charles Health System-Redmond
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Dickson City, Pennsylvania, United States, 18519
        • Geisinger Cancer Center Dickson City
      • Hazleton, Pennsylvania, United States, 18201
        • Geisinger Medical Center-Cancer Center Hazleton
      • Lewisburg, Pennsylvania, United States, 17837
        • Geisinger Medical Oncology-Lewisburg
      • Pottsville, Pennsylvania, United States, 17901
        • Geisinger Cancer Services-Pottsville
      • Scranton, Pennsylvania, United States, 18510
        • Community Medical Center
      • Selinsgrove, Pennsylvania, United States, 17870
        • Geisinger Medical Oncology-Selinsgrove
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
    • South Carolina
      • Bluffton, South Carolina, United States, 29910
        • Saint Joseph's/Candler - Bluffton Campus
      • Hilton Head Island, South Carolina, United States, 29926
        • The Radiation Oncology Center-Hilton Head/Bluffton
      • Hilton Head Island, South Carolina, United States, 29926-3827
        • South Carolina Cancer Specialists PC
    • Tennessee
      • Collierville, Tennessee, United States, 38017
        • Baptist Memorial Hospital and Cancer Center-Collierville
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital and Cancer Center-Memphis
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital for Women
    • Virginia
      • Martinsville, Virginia, United States, 24112
        • Sovah Health Martinsville
      • Mechanicsville, Virginia, United States, 23116
        • Bon Secours Memorial Regional Medical Center
      • Midlothian, Virginia, United States, 23114
        • Bon Secours Saint Francis Medical Center
      • Midlothian, Virginia, United States, 23113
        • Bon Secours Westchester Emergency Center
      • Richmond, Virginia, United States, 23226
        • Bon Secours Saint Mary's Hospital
      • Richmond, Virginia, United States, 23230
        • Bon Secours Cancer Institute at Reynolds Crossing
      • Richmond, Virginia, United States, 23223
        • Bon Secours Richmond Community Hospital
    • Washington
      • Aberdeen, Washington, United States, 98520
        • Providence Regional Cancer System-Aberdeen
      • Bellingham, Washington, United States, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Centralia, Washington, United States, 98531
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, United States, 98026
        • Swedish Cancer Institute-Edmonds
      • Everett, Washington, United States, 98201
        • Providence Regional Cancer Partnership
      • Issaquah, Washington, United States, 98029
        • Swedish Cancer Institute-Issaquah
      • Kennewick, Washington, United States, 99336
        • Kadlec Clinic Hematology and Oncology
      • Lacey, Washington, United States, 98503
        • Providence Regional Cancer System-Lacey
      • Longview, Washington, United States, 98632
        • PeaceHealth Saint John Medical Center
      • Mount Vernon, Washington, United States, 98274
        • Skagit Regional Health Cancer Care Center
      • Port Townsend, Washington, United States, 98368
        • Jefferson Healthcare
      • Renton, Washington, United States, 98055
        • Valley Medical Center
      • Seattle, Washington, United States, 98107
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center-First Hill
      • Seattle, Washington, United States, 98122-5711
        • Swedish Medical Center-Cherry Hill
      • Sedro-Woolley, Washington, United States, 98284
        • PeaceHealth United General Medical Center
      • Spokane, Washington, United States, 99202
        • Cancer Care Northwest - Spokane South
      • Spokane, Washington, United States, 99216
        • Cancer Care Northwest-Valley
      • Spokane, Washington, United States, 99218
        • Cancer Care Northwest-North Spokane
      • Vancouver, Washington, United States, 98664
        • PeaceHealth Southwest Medical Center
      • Walla Walla, Washington, United States, 99362
        • Providence Saint Mary Regional Cancer Center
      • Yakima, Washington, United States, 98902
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • ThedaCare Regional Cancer Center
      • Appleton, Wisconsin, United States, 54915
        • Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton
      • Berlin, Wisconsin, United States, 54923
        • ThedaCare Cancer Care - Berlin
      • Brookfield, Wisconsin, United States, 53045
        • Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield
      • Chilton, Wisconsin, United States, 53014
        • Ascension Calumet Hospital-Chilton
      • Chippewa Falls, Wisconsin, United States, 54729
        • Marshfield Clinic-Chippewa Center
      • Eau Claire, Wisconsin, United States, 54701
        • Marshfield Medical Center-EC Cancer Center
      • Franklin, Wisconsin, United States, 53132
        • Ascension Southeast Wisconsin Hospital - Franklin
      • Franklin, Wisconsin, United States, 53132
        • Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Medical Center
      • Ladysmith, Wisconsin, United States, 54848
        • Marshfield Medical Center - Ladysmith
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Center-Marshfield
      • Mequon, Wisconsin, United States, 53097
        • Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon
      • Milwaukee, Wisconsin, United States, 53210
        • Ascension Southeast Wisconsin Hospital-Saint Joseph-Milwaukee
      • Milwaukee, Wisconsin, United States, 53211
        • Ascension Columbia Saint Mary's Hospital-Milwaukee Campus
      • Milwaukee, Wisconsin, United States, 53215
        • Ascension Saint Francis Hospital-Milwaukee
      • Minocqua, Wisconsin, United States, 54548
        • Marshfield Medical Center - Minocqua
      • Neenah, Wisconsin, United States, 54956
        • ThedaCare Regional Medical Center - Neenah
      • Neillsville, Wisconsin, United States, 54456
        • Marshfield Medical Center - Neillsville
      • New London, Wisconsin, United States, 54961
        • ThedaCare Cancer Care - New London
      • New Richmond, Wisconsin, United States, 54017
        • Cancer Center of Western Wisconsin
      • Oshkosh, Wisconsin, United States, 54904
        • ThedaCare Cancer Care - Oshkosh
      • Oshkosh, Wisconsin, United States, 54904
        • Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh
      • Racine, Wisconsin, United States, 53405
        • Ascension All Saints Hospital-Spring Street-Racine
      • Rice Lake, Wisconsin, United States, 54868
        • Marshfield Medical Center-Rice Lake
      • Shawano, Wisconsin, United States, 54166
        • ThedaCare Cancer Care - Shawano
      • Stevens Point, Wisconsin, United States, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Waupaca, Wisconsin, United States, 54981
        • ThedaCare Cancer Care - Waupaca
      • Wausau, Wisconsin, United States, 54401
        • Marshfield Clinic-Wausau Center
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Cancer Care-Wausau
      • Wauwatosa, Wisconsin, United States, 53226
        • Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa
      • Weston, Wisconsin, United States, 54476
        • Marshfield Medical Center - Weston
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Marshfield Clinic - Wisconsin Rapids Center
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Memorial Hospital of Laramie County
      • Cody, Wyoming, United States, 82414
        • Billings Clinic-Cody

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • NON-PATIENTS PARTICIPANTS: Participant must speak English
  • NON-PATIENTS PARTICIPANTS: Participant must be employed at National Cancer Institute Community Oncology Research Program (NCORP) site for at least six months
  • NON-PATIENTS PARTICIPANTS: Participant must be able to provide informed consent to participate in this study

  • NON-PATIENTS PARTICIPANTS: Participant must be one of the following:

    • A study coordinator with a role involving use of CostCOM intervention price transparency and financial navigation platform
    • A practice oncology provider (i.e., physician or mid-level), or
    • A practice financial counselor, social workers, financial navigators, or pharmacist who have provided care or been in contact (in the last 3 months) to a patient who was assigned to the CostCOM arm, and who completed the at least 6 month study follow-up
  • PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must be ≥ 18 years of age
  • PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must be fluent in written and spoken English OR patient must be fluent in written and spoken Spanish
  • PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must be within 120 days of a new diagnosis of any solid cancer of any stage at the time of Step 0
  • PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must have had their first medical oncology visit at the time of Step 0
  • PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must have initiated oral or intravenous (IV) cancer systemic therapy or have received a prescription order with stated intent to initiate within 30 days following Step 0 consent
  • PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patients must not have indolent cancer undergoing observation alone (i.e., active surveillance)
  • PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patients must not be receiving palliative or hospice care alone
  • PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not be undergoing curative surgery alone or radiation therapy alone. (Must be receiving systemic therapy), unless they are receiving systemic therapy
  • PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must confirm that they intend to receive their care or monitoring at one of the participating NCORP practices

  • PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must have the ability to understand and the willingness to sign a written informed consent document.

    • Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available are not eligible

  • PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not have an Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3, OR

    • Patient must not be deemed medically unable to participate in the study by the study investigators or an oncology clinician (i.e., referral to hospice)
  • PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not be enrolled in treatment clinical trials where cancer systemic therapy is provided at no cost to the patient

  • PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not be enrolled in EAQ221CD or S1912CD given financial navigation is offered as part of these two trials.

    • NOTE: If S1912CD is activated in a participating practice, S1912CD should be offered first to patients with metastatic cancer meeting eligibility criteria for S1912CD. Only if a patient is not eligible or not interested in participating in S1912CD, the EAQ222CD can be offered. For early stage cancer, EAQ222CD can be offered first given S1912CD does not enroll patients with early stage cancer

  • PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not be enrolled in other clinical trials where OOPC communication or financial navigation (i.e., professional guidance to identify financial assistance programs to alleviate cost of care) is being offered as part of the trial

    • NOTE: If a trial is offering financial counseling alone without financial navigation patients are allowed to co-enroll
    • NOTE: Gift cards for survey completion, or parking passes are not considered financial navigation
  • PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patient must meet all the eligibility criteria for step 0
  • PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patient must have signed a written informed consent form
  • PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patient must have a completed baseline survey in ECOG American College of Radiology Imaging Network Systems for Easy Entry of Patient Reported Outcomes (EASEE-PRO) within 30 days of the date of OPEN registration and consent (step 0)
  • PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patients must have initiated their cancer treatment (i.e., IV or oral systemic therapy) either before or within 30 days of the date of OPEN registration and consent (step 0)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ARM A (Enhanced usual care)
Patients receive PAF brochure describing financial navigation services.
Other: Survey Administration
Ancillary studies
Other: Best Practice
Receive PAF brochure describing financial navigation services
Other Names:
  • standard of care
  • standard therapy
Experimental: ARM B (CostCOM)
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.
Other: Survey Administration
Ancillary studies
Other: Best Practice
Receive PAF brochure describing financial navigation services
Other Names:
  • standard of care
  • standard therapy
Other: Financial Navigation
Receive CostCOM financial counseling
Other Names:
  • Financial Navigation Program
Experimental: Non-patient participants: (interview)
Non-patient 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.
Other: Survey Administration
Ancillary studies
Other: Interview
Participate in a 1 on 1 in-depth interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-related cancer care non-adherence
Time Frame: 12 months
Cost-related cancer care non-adherence is defined as a positive response to any of the following due to costs: Delayed, forewent, stopped, or changed prescribed cancer medication; or delayed, forewent, or refused recommended cancer tests, or cancer office visits. Will be calculated as a report of non-adherence at any point up through the 12mo follow-up survey.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Material Financial Hardship
Time Frame: at 12 months
Rate of material hardship at each time point is a binary (yes/no) composite measure defined as a positive response to any of the following: (1) home sale, refinance or move to affordable rental, (2) loans, (3) reaching credit limits, and (4) bankruptcy because of your cancer care, or its treatment (adapted from Medical Expenditure Panel Survey).Material hardship at 12 months is measured as report of material hardship at any of the 3, 6 and 12 follow-ups.
at 12 months
Patient-reported financial worry
Time Frame: At baseline and at 3, 6 and 12 months
Measured by 12-item Comprehensive Score for Financial Toxicity (de Souza COST measure). Composite Scores range between 0-44 with higher the scores reflecting better the Financial Well-Being. Item 12 , an unscored summary item, will be used separately as a single item measure of financial worry. Mean score and changes in mean scores from baseline at each time point between the arms will be compared using two-sample t-tests.
At baseline and at 3, 6 and 12 months
Patient-reported satisfaction with care at 12 months
Time Frame: At baseline and at 3, 6 and 12 months
Satisfaction with the care will be measured using Consumer Assessment of Healthcare Providers and Systems (CAHPS) Cancer Care Survey questions. Composite items are rated on a scale of 0 to 10, with 0 being the worst and 10 being the best. Mean score and changes in mean scores from baseline at each time point between the arms will be compared using two-sample t-tests.
At baseline and at 3, 6 and 12 months
Patient-reported Quality of life - mental and physical health
Time Frame: At baseline and at 3, 6 and 12 months
Measured using the 10-item Patient-Reported Outcomes Measurement Information System (PROMIS-10) version 1.2 Global Health. A T-score will be calculated for each of the global mental health and global physical health sections with a higher PROMIS T-score representing more of the concept being measured (mental/physical health). T-scores for the general population have a mean of 50 and a standard deviation (SD) of 10.Thus, a person who has T- scores of 60 for the Global Physical Health or Global Mental Health scales is one standard deviation better (more healthy) than the general population Mean score and changes in mean scores from baseline at each time point between the arms will be compared using two-sample t-tests.
At baseline and at 3, 6 and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Out of pocket cost (OOPC) accuracy
Time Frame: At 3, 6 and 12 months
Mean absolute difference between OOPC estimates for the first cycle of therapy (as estimated by TailorMed Medical Incorporated) and the actual billed out of pocket (OOP) costs (as reported by patients based on their co-pays or medical bills).
At 3, 6 and 12 months
Proportion of study patient participants that are of minority racial/ethnic background, and with public insurance will be measured and compared with that of practice patient population.
Time Frame: Up to 12 months
Proportion of patients with specific characteristics, including racial, ethnic, payer mix, and neighborhood deprivation indices. Proportions will be compared between study participants and practice patient population.
Up to 12 months
Patient reported satisfaction with intervention
Time Frame: 39 months after enrollment of first study participant

Qualitative interviews utilizing the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework was used to guide the evaluation questions and examine the effectiveness of the intervention and implementation outcomes.

Participants describe their experience with various components of the CostCOM intervention: price transparency, financial navigation, and financial counseling, barriers and facilitators to participation, and feedback on what they liked and disliked about CostCOM, how it impacted their care, satisfaction with care, and what they would change to make it more helpful or engaging. The outcome measures are the proportion of subjects in the top 10 categories identified (5 for each like and dislike)
39 months after enrollment of first study participant
Receipt of financial navigation via internal practice or external resources
Time Frame: 12 months

Proportion of subjects receiving (at least 1 session) of financial navigation via study intervention, internal practice, or external resources.

Receipt of financial counseling or financial assistance will be documented via treating clinic as extracted from medical records and intervention participants via reports from TailorMed Medical Incorporated
12 months
Evaluate longitudinal changes in Cost-related cancer care non-adherence, material hardship, financial worry, quality of life and satisfaction with care
Time Frame: At baseline and at 3, 6 and 12 months
Cost-related cancer care outcomes of non-adherence, material hardship, financial worry, quality of life and satisfaction with care (reported above) are included in a Regression Model (GEE)
At baseline and at 3, 6 and 12 months
longitudinal changes in cost-related cancer care non-adherence
Time Frame: At baseline, 3, 6 and 12 months

The effect of time (unitless Betas (slope)) will be estimated using a regression model (stage-stratified GEE analyses) for the Cost-related Outcomes non-adherence, material hardship, financial worry, quality of life, and satisfaction with care Regression intervention parameter (COSTCOM v EUC) will use EUC as the reference category.

Cost-related cancer care non-adherence is defined as a positive response to any of the following due to costs: Delayed, forewent, stopped, or changed prescribed cancer medication; or delayed, forewent, or refused recommended cancer tests, or cancer office visits
At baseline, 3, 6 and 12 months
longitudinal changes in cost-related cancer care material hardship
Time Frame: At baseline, 3, 6 and 12 months

The effect of time (unitless Betas (slope)) will be estimated using a regression model (stage-stratified GEE analyses) for the Cost-related Outcomes non-adherence, material hardship, financial worry, quality of life, and satisfaction with care Regression intervention parameter (COSTCOM v EUC) will use EUC as the reference category.

Material hardship is a binary (yes/no) composite measure defined as a positive response to any of the following: (1) home sale, refinance or move to affordable rental, (2) loans, (3) reaching credit limits, and (4) bankruptcy because of your cancer care, or its treatment (adapted from Medical Expenditure Panel Survey).
At baseline, 3, 6 and 12 months
longitudinal changes in cost-related cancer care financial worry
Time Frame: At baseline, 3, 6 and 12 months

The effect of time (unitless Betas (slope)) will be estimated using a regression model (stage-stratified GEE analyses) for the Cost-related Outcomes non-adherence, material hardship, financial worry, quality of life, and satisfaction with care Regression intervention parameter (COSTCOM v EUC) will use EUC as the reference category.

Financial Worry measured by the 12-item Comprehensive Score for Financial Toxicity (de Souza COST measure). Composite Scores range between 0-44 with higher the scores reflecting better the Financial Well-Being. Item 12 , an unscored summary item, will be used separately as a single item measure of financial worry. Mean score and changes in mean scores from baseline at each time point between the arms will be compared using two-sample t-tests.
At baseline, 3, 6 and 12 months
longitudinal changes in cost-related cancer care quality of life
Time Frame: At baseline, 3, 6 and 12 months

The effect of time (unitless Betas (slope)) will be estimated using a regression model (stage-stratified GEE analyses) for the Cost-related Outcomes non-adherence, material hardship, financial worry, quality of life, and satisfaction with care Regression intervention parameter (COSTCOM v EUC) will use EUC as the reference category.

Quality of life is measured using the 10-item Patient-Reported Outcomes Measurement Information System (PROMIS-10) ver 1.2 Global Health. A T-score will be calculated for each global mental health and global physical health sections with a higher PROMIS T-score representing more of the concept being measured (mental/physical health). T-scores for the general population have a mean of 50 and a standard deviation (SD) of 10.Thus, a person who has T- scores of 60 for the Global Physical Health or Global Mental Health scales is one standard deviation better (more healthy) than the general population Mean score and changes in mean scores from base
At baseline, 3, 6 and 12 months
longitudinal changes in cost-related cancer care satisfaction with care
Time Frame: At baseline, 3, 6 and 12 months

The effect of time (unitless Betas (slope)) will be estimated using a regression model (stage-stratified GEE analyses) for the Cost-related Outcome Satisfaction with care Regression intervention parameter (COSTCOM v EUC) will use EUC as the reference category.

Satisfaction with the care is measured using the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Cancer Care Survey questions. Composite items are rated on a scale of 0 to 10, with 0 being the worst and 10 being the best.
At baseline, 3, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ECOG-ACRIN Cancer Research Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Gelareh Sadigh, ECOG-ACRIN Cancer Research Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2024

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Actual)

March 6, 2024

Study Record Updates

Last Update Posted (Actual)

September 4, 2026

Last Update Submitted That Met QC Criteria

September 2, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EAQ222CD (Other Identifier: CTEP)
  • UG1CA189828 (U.S. NIH Grant/Contract)
  • NCI-2023-09944 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • ECOG-ACRIN-EAQ222CD (Other Identifier: DCP)
  • R01CA272680 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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