Program nawigacji finansowej mający na celu poprawę zrozumienia i zarządzania finansowymi aspektami opieki onkologicznej dla pacjentów i ich małżonków (CREDIT)
Randomizowana próba dotycząca trudności finansowych związanych z rakiem poprzez dostarczenie proaktywnej interwencji w zakresie nawigacji finansowej (CREDIT)
This clinical trial examines a financial navigation program in helping patients (and their spouses or partner caregivers, if participating) understand and better manage the financial aspects of cancer care. Cancer patients and their spouse/partner caregivers may be at high risk for financial problems because of the cost of cancer treatment. A financial navigator is a person or team who works with patients and their families to help them reduce stress or hardship related to the cost of cancer treatment. Financial navigators help patients understand their out-of-pocket expenses and what their health insurance plans may cover. Financial navigation may also help patients set up payment plans, find cost-saving methods for treatments, and improve access to healthcare services that the patient needs. Providing financial navigation to patients may help reduce financial worries and improve quality of life.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
PRIMARY OBJECTIVE:
I. To determine whether a proactive financial navigation program for patients planning to receive anti-cancer treatment decreases the risk of material household financial hardship over 12 months among patients with newly diagnosed or recurrent metastatic solid tumor, or a newly diagnosed hematologic malignancy.
SECONDARY OBJECTIVES:
I. To examine whether proactive financial navigation improves patient quality of life.
II. To examine whether proactive financial navigation decreases financial worry among patients relative to usual care and explore the extent to which financial worry correlates with financial hardship.
III. To explore whether the proactive financial navigation intervention leads to decreased cost-related medication non-adherence and fewer patient emergency department (ED) visits and unplanned hospital admissions.
ADDITIONAL OBJECTIVES:
I. To explore the impact of proactive financial navigation on spouse/partner caregiver financial hardship, quality of life, and caregiver burden and evaluate the concordance between patient and caregiver credit data.
II. To explore the utilization of financial navigation services by younger, financially fragile, and lower income patients and households and evaluate the moderator effect of age, financial fragility, and income on the impact of the proactive financial navigation intervention.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive financial literacy training consisting of watching online educational videos over 2-8 minutes. Patients also complete questionnaires over 30-60 minutes about education, employment, finances (assets, debt), insurance, and quality of life (financial worry) and have credit reports assessed at baseline and 3, 6, and 12 months.
GROUP II: Patients receive financial literacy training consisting of watching online educational videos over 2-8 minutes. Patients also meet with Consumer Education and Training Services (CENTS) counselor and Patient Advocate Foundation (PAF) case manager over approximately 1 hour every month for 6 months (with each group). Patients also complete questionnaires over 30-60 minutes about education, employment, finances (assets, debt), insurance, and quality of life (financial worry) and have credit reports assessed at baseline and 3, 6, and 12 months.
Spouse/partner caregiver participation is optional. If a spouse/partner caregiver is participating in the trial along with the patient. If participating, the spouse/partner caregiver receives the same intervention as the patient and will complete questionnaires and have credit reports assessed at baseline and 3, 6, and 12 months.
SAMPLE SIZE: Study participants include both patients and optional spouse/partner caregivers. Study enrollment targets are based entirely on patients, but the anticipated number of participants includes both groups. We expect to enroll 326 patients and approximately 196 spouse/partner caregivers for a total of 522 anticipated participants, but the study will be closed to accrual when the patient accrual target of 326 is reached, regardless of the number of participating spouse/partner caregivers.
Typ studiów
Typ studiów
Zapisy (Rzeczywisty)
Zapisy
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Manati, Portoryko, 00674
- Doctors Cancer Center
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San Juan, Portoryko, 00927
- Centro Comprensivo de Cancer de UPR
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-
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Alaska
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Fairbanks, Alaska, Stany Zjednoczone, 99701
- Fairbanks Memorial Hospital
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Arkansas
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Fort Smith, Arkansas, Stany Zjednoczone, 72903
- Mercy Hospital Fort Smith
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California
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Antioch, California, Stany Zjednoczone, 94531
- Kaiser Permanente-Deer Valley Medical Center
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Dublin, California, Stany Zjednoczone, 94568
- Kaiser Permanente Dublin
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Dublin, California, Stany Zjednoczone, 94568
- Epic Care-Dublin
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Emeryville, California, Stany Zjednoczone, 94608
- Epic Care Partners in Cancer Care
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Fremont, California, Stany Zjednoczone, 94538
- Kaiser Permanente-Fremont
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Fresno, California, Stany Zjednoczone, 93720
- Kaiser Permanente-Fresno
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Martinez, California, Stany Zjednoczone, 94553-3156
- Contra Costa Regional Medical Center
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Modesto, California, Stany Zjednoczone, 95356
- Kaiser Permanente-Modesto
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Oakland, California, Stany Zjednoczone, 94611
- Kaiser Permanente-Oakland
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Redwood City, California, Stany Zjednoczone, 94063
- Kaiser Permanente- Marshall Medical Offices
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Richmond, California, Stany Zjednoczone, 94801
- Kaiser Permanente-Richmond
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Roseville, California, Stany Zjednoczone, 95661
- Kaiser Permanente-Roseville
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Sacramento, California, Stany Zjednoczone, 95814
- Kaiser Permanente Downtown Commons
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Sacramento, California, Stany Zjednoczone, 95823
- Kaiser Permanente-South Sacramento
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San Francisco, California, Stany Zjednoczone, 94115
- Kaiser Permanente-San Francisco
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San Jose, California, Stany Zjednoczone, 95119
- Kaiser Permanente-Santa Teresa-San Jose
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San Leandro, California, Stany Zjednoczone, 94577
- Kaiser Permanente San Leandro
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San Rafael, California, Stany Zjednoczone, 94903
- Kaiser San Rafael-Gallinas
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Santa Clara, California, Stany Zjednoczone, 95051
- Kaiser Permanente Medical Center - Santa Clara
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Santa Rosa, California, Stany Zjednoczone, 95403
- Kaiser Permanente-Santa Rosa
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South San Francisco, California, Stany Zjednoczone, 94080
- Kaiser Permanente-South San Francisco
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Stockton, California, Stany Zjednoczone, 95210
- Kaiser Permanente-Stockton
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Vacaville, California, Stany Zjednoczone, 95688
- Kaiser Permanente Medical Center-Vacaville
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Vallejo, California, Stany Zjednoczone, 94589
- Kaiser Permanente-Vallejo
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Walnut Creek, California, Stany Zjednoczone, 94596
- Kaiser Permanente-Walnut Creek
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Walnut Creek, California, Stany Zjednoczone, 94597
- Epic Care Cyberknife Center
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Colorado
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Aurora, Colorado, Stany Zjednoczone, 80012
- Rocky Mountain Cancer Centers-Aurora
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Boulder, Colorado, Stany Zjednoczone, 80304
- Rocky Mountain Cancer Centers-Boulder
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Centennial, Colorado, Stany Zjednoczone, 80112
- Rocky Mountain Cancer Centers - Centennial
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Denver, Colorado, Stany Zjednoczone, 80205
- Kaiser Permanente-Franklin
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Denver, Colorado, Stany Zjednoczone, 80218
- Rocky Mountain Cancer Centers-Midtown
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Denver, Colorado, Stany Zjednoczone, 80220
- Rocky Mountain Cancer Centers-Rose
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Englewood, Colorado, Stany Zjednoczone, 80113
- Rocky Mountain Cancer Centers - Swedish
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Lafayette, Colorado, Stany Zjednoczone, 80026
- Kaiser Permanente-Rock Creek
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Lakewood, Colorado, Stany Zjednoczone, 80228
- Rocky Mountain Cancer Centers-Lakewood
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Littleton, Colorado, Stany Zjednoczone, 80120
- Rocky Mountain Cancer Centers-Littleton
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Lone Tree, Colorado, Stany Zjednoczone, 80124
- Kaiser Permanente-Lone Tree
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Lone Tree, Colorado, Stany Zjednoczone, 80124
- Rocky Mountain Cancer Centers-Sky Ridge
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Thornton, Colorado, Stany Zjednoczone, 80260
- Rocky Mountain Cancer Centers-Thornton
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Delaware
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Frankford, Delaware, Stany Zjednoczone, 19945
- Beebe South Coastal Health Campus
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Newark, Delaware, Stany Zjednoczone, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, Stany Zjednoczone, 19713
- Medical Oncology Hematology Consultants PA
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Rehoboth Beach, Delaware, Stany Zjednoczone, 19971
- Beebe Health Campus
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Georgia
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Augusta, Georgia, Stany Zjednoczone, 30912
- Augusta University Medical Center
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Columbus, Georgia, Stany Zjednoczone, 31904
- John B Amos Cancer Center
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Savannah, Georgia, Stany Zjednoczone, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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Savannah, Georgia, Stany Zjednoczone, 31404
- Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, Stany Zjednoczone, 96813
- Queen's Medical Center
-
Honolulu, Hawaii, Stany Zjednoczone, 96813
- Hawaii Cancer Care Inc - Waterfront Plaza
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Honolulu, Hawaii, Stany Zjednoczone, 96813
- Straub Clinic and Hospital
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Honolulu, Hawaii, Stany Zjednoczone, 96813
- University of Hawaii Cancer Center
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Honolulu, Hawaii, Stany Zjednoczone, 96826
- Kapiolani Medical Center for Women and Children
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Honolulu, Hawaii, Stany Zjednoczone, 96819
- Kaiser Permanente Moanalua Medical Center
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‘Aiea, Hawaii, Stany Zjednoczone, 96701
- Hawaii Cancer Care - Westridge
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‘Aiea, Hawaii, Stany Zjednoczone, 96701
- Pali Momi Medical Center
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Illinois
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Alton, Illinois, Stany Zjednoczone, 62002
- Saint Anthony's Health
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Aurora, Illinois, Stany Zjednoczone, 60504
- Rush - Copley Medical Center
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Bloomington, Illinois, Stany Zjednoczone, 61704
- Illinois CancerCare-Bloomington
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Bloomington, Illinois, Stany Zjednoczone, 61701
- Bromenn Lifecare Center
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Canton, Illinois, Stany Zjednoczone, 61520
- Illinois CancerCare-Canton
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Carthage, Illinois, Stany Zjednoczone, 62321
- Illinois CancerCare-Carthage
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Centralia, Illinois, Stany Zjednoczone, 62801
- Centralia Oncology Clinic
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Danville, Illinois, Stany Zjednoczone, 61832
- Carle at The Riverfront
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Decatur, Illinois, Stany Zjednoczone, 62526
- Cancer Care Specialists of Illinois - Decatur
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Dixon, Illinois, Stany Zjednoczone, 61021
- Illinois CancerCare-Dixon
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Effingham, Illinois, Stany Zjednoczone, 62401
- Crossroads Cancer Center
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Eureka, Illinois, Stany Zjednoczone, 61530
- Illinois CancerCare-Eureka
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Galesburg, Illinois, Stany Zjednoczone, 61401
- Illinois CancerCare-Galesburg
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Kewanee, Illinois, Stany Zjednoczone, 61443
- Illinois CancerCare-Kewanee Clinic
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Macomb, Illinois, Stany Zjednoczone, 61455
- Illinois CancerCare-Macomb
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Mattoon, Illinois, Stany Zjednoczone, 61938
- Carle Physician Group-Mattoon/Charleston
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Mount Vernon, Illinois, Stany Zjednoczone, 62864
- Good Samaritan Regional Health Center
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Normal, Illinois, Stany Zjednoczone, 61761
- Carle Cancer Institute Normal
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Normal, Illinois, Stany Zjednoczone, 61761
- Bromenn Regional Medical Center
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O'Fallon, Illinois, Stany Zjednoczone, 62269
- Cancer Care Center of O'Fallon
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Ottawa, Illinois, Stany Zjednoczone, 61350
- Illinois CancerCare-Ottawa Clinic
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Pekin, Illinois, Stany Zjednoczone, 61554
- Illinois CancerCare-Pekin
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Peoria, Illinois, Stany Zjednoczone, 61615
- Illinois CancerCare-Peoria
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Peru, Illinois, Stany Zjednoczone, 61354
- Illinois CancerCare-Peru
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Princeton, Illinois, Stany Zjednoczone, 61356
- Illinois CancerCare-Princeton
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Springfield, Illinois, Stany Zjednoczone, 62781
- Memorial Medical Center
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Springfield, Illinois, Stany Zjednoczone, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Stany Zjednoczone, 62702
- Springfield Clinic
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Urbana, Illinois, Stany Zjednoczone, 61801
- Carle Cancer Center
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Washington, Illinois, Stany Zjednoczone, 61571
- Illinois CancerCare - Washington
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Yorkville, Illinois, Stany Zjednoczone, 60560
- Rush-Copley Healthcare Center
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Iowa
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Ames, Iowa, Stany Zjednoczone, 50010
- Mary Greeley Medical Center
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Ames, Iowa, Stany Zjednoczone, 50010
- McFarland Clinic - Ames
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Boone, Iowa, Stany Zjednoczone, 50036
- McFarland Clinic - Boone
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Cedar Rapids, Iowa, Stany Zjednoczone, 52403
- Oncology Associates at Mercy Medical Center
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Des Moines, Iowa, Stany Zjednoczone, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Stany Zjednoczone, 50309
- Medical Oncology and Hematology Associates-Des Moines
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Fort Dodge, Iowa, Stany Zjednoczone, 50501
- McFarland Clinic - Trinity Cancer Center
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Jefferson, Iowa, Stany Zjednoczone, 50129
- McFarland Clinic - Jefferson
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Marshalltown, Iowa, Stany Zjednoczone, 50158
- McFarland Clinic - Marshalltown
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Kansas
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Garden City, Kansas, Stany Zjednoczone, 67846
- Central Care Cancer Center - Garden City
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Great Bend, Kansas, Stany Zjednoczone, 67530
- Central Care Cancer Center - Great Bend
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Hays, Kansas, Stany Zjednoczone, 67601
- HaysMed University of Kansas Health System
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Lawrence, Kansas, Stany Zjednoczone, 66044
- Lawrence Memorial Hospital
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Olathe, Kansas, Stany Zjednoczone, 66061
- Olathe Health Cancer Center
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Overland Park, Kansas, Stany Zjednoczone, 66210
- University of Kansas Cancer Center-Overland Park
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Overland Park, Kansas, Stany Zjednoczone, 66211
- University of Kansas Hospital-Indian Creek Campus
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Pittsburg, Kansas, Stany Zjednoczone, 66762
- Ascension Via Christi - Pittsburg
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Salina, Kansas, Stany Zjednoczone, 67401
- Salina Regional Health Center
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Topeka, Kansas, Stany Zjednoczone, 66606
- University of Kansas Health System Saint Francis Campus
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Westwood, Kansas, Stany Zjednoczone, 66205
- University of Kansas Hospital-Westwood Cancer Center
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Kentucky
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Bardstown, Kentucky, Stany Zjednoczone, 40004
- Flaget Memorial Hospital
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Lexington, Kentucky, Stany Zjednoczone, 40504
- Saint Joseph Radiation Oncology Resource Center
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Lexington, Kentucky, Stany Zjednoczone, 40509
- Saint Joseph Hospital East
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London, Kentucky, Stany Zjednoczone, 40741
- Saint Joseph London
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Louisiana
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Baton Rouge, Louisiana, Stany Zjednoczone, 70805
- LSU Health Baton Rouge-North Clinic
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Baton Rouge, Louisiana, Stany Zjednoczone, 70809
- Louisiana Hematology Oncology Associates LLC
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Baton Rouge, Louisiana, Stany Zjednoczone, 70809
- Our Lady of the Lake Physicians Group - Medical Oncology
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Baton Rouge, Louisiana, Stany Zjednoczone, 70817
- Our Lady of the Lake Medical Oncology
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Baton Rouge, Louisiana, Stany Zjednoczone, 70817
- Louisiana Hematology Oncology Associates
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Shreveport, Louisiana, Stany Zjednoczone, 71103
- LSU Health Sciences Center at Shreveport
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Maine
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Augusta, Maine, Stany Zjednoczone, 04330
- Harold Alfond Center for Cancer Care
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Biddeford, Maine, Stany Zjednoczone, 04005
- MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
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Norway, Maine, Stany Zjednoczone, 04268
- Stephens Memorial Hospital
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Sanford, Maine, Stany Zjednoczone, 04073
- MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
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Scarborough, Maine, Stany Zjednoczone, 04074
- Maine Medical Center- Scarborough Campus
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South Portland, Maine, Stany Zjednoczone, 04106
- Maine Medical Partners - South Portland
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Michigan
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Ann Arbor, Michigan, Stany Zjednoczone, 48106
- Saint Joseph Mercy Hospital
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Battle Creek, Michigan, Stany Zjednoczone, 49017
- Bronson Battle Creek
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Brighton, Michigan, Stany Zjednoczone, 48114
- Saint Joseph Mercy Brighton
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Canton, Michigan, Stany Zjednoczone, 48188
- Saint Joseph Mercy Canton
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Chelsea, Michigan, Stany Zjednoczone, 48118
- Saint Joseph Mercy Chelsea
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Flint, Michigan, Stany Zjednoczone, 48503
- Genesee Cancer and Blood Disease Treatment Center
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Flint, Michigan, Stany Zjednoczone, 48503
- Genesee Hematology Oncology PC
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Flint, Michigan, Stany Zjednoczone, 48503
- Genesys Hurley Cancer Institute
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Grand Rapids, Michigan, Stany Zjednoczone, 49503
- Spectrum Health at Butterworth Campus
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Grand Rapids, Michigan, Stany Zjednoczone, 49503
- Trinity Health Grand Rapids Hospital
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Kalamazoo, Michigan, Stany Zjednoczone, 49007
- West Michigan Cancer Center
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Livonia, Michigan, Stany Zjednoczone, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
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Reed City, Michigan, Stany Zjednoczone, 49677
- Spectrum Health Reed City Hospital
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Traverse City, Michigan, Stany Zjednoczone, 49684
- Munson Medical Center
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Minnesota
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Brainerd, Minnesota, Stany Zjednoczone, 56401
- Essentia Health Saint Joseph's Medical Center
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Burnsville, Minnesota, Stany Zjednoczone, 55337
- Minnesota Oncology - Burnsville
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Coon Rapids, Minnesota, Stany Zjednoczone, 55433
- Mercy Hospital
-
Detroit Lakes, Minnesota, Stany Zjednoczone, 56501
- Essentia Health Saint Mary's - Detroit Lakes Clinic
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Duluth, Minnesota, Stany Zjednoczone, 55805
- Essentia Health Cancer Center
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Edina, Minnesota, Stany Zjednoczone, 55435
- Fairview Southdale Hospital
-
Fosston, Minnesota, Stany Zjednoczone, 56542
- Essentia Health - Fosston
-
Fridley, Minnesota, Stany Zjednoczone, 55432
- Unity Hospital
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Maple Grove, Minnesota, Stany Zjednoczone, 55369
- Fairview Clinics and Surgery Center Maple Grove
-
Maplewood, Minnesota, Stany Zjednoczone, 55109
- Saint John's Hospital - Healtheast
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Minneapolis, Minnesota, Stany Zjednoczone, 55415
- Hennepin County Medical Center
-
Minneapolis, Minnesota, Stany Zjednoczone, 55407
- Abbott-Northwestern Hospital
-
Monticello, Minnesota, Stany Zjednoczone, 55362
- Monticello Cancer Center
-
New Ulm, Minnesota, Stany Zjednoczone, 56073
- New Ulm Medical Center
-
Saint Louis Park, Minnesota, Stany Zjednoczone, 55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Paul, Minnesota, Stany Zjednoczone, 55101
- Regions Hospital
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Stillwater, Minnesota, Stany Zjednoczone, 55082
- Lakeview Hospital
-
Waconia, Minnesota, Stany Zjednoczone, 55387
- Ridgeview Medical Center
-
Willmar, Minnesota, Stany Zjednoczone, 56201
- Rice Memorial Hospital
-
Woodbury, Minnesota, Stany Zjednoczone, 55125
- Minnesota Oncology Hematology PA-Woodbury
-
Wyoming, Minnesota, Stany Zjednoczone, 55092
- Fairview Lakes Medical Center
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Missouri
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Ballwin, Missouri, Stany Zjednoczone, 63011
- Saint Louis Cancer and Breast Institute-Ballwin
-
Bolivar, Missouri, Stany Zjednoczone, 65613
- Central Care Cancer Center - Bolivar
-
Cape Girardeau, Missouri, Stany Zjednoczone, 63703
- Saint Francis Medical Center
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Farmington, Missouri, Stany Zjednoczone, 63640
- Parkland Health Center - Farmington
-
Joplin, Missouri, Stany Zjednoczone, 64804
- Freeman Health System
-
Joplin, Missouri, Stany Zjednoczone, 64804
- Mercy Hospital Joplin
-
Kansas City, Missouri, Stany Zjednoczone, 64154
- University of Kansas Cancer Center - North
-
Kansas City, Missouri, Stany Zjednoczone, 64108
- Truman Medical Centers
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Lee's Summit, Missouri, Stany Zjednoczone, 64064
- University of Kansas Cancer Center - Lee's Summit
-
North Kansas City, Missouri, Stany Zjednoczone, 64116
- University of Kansas Cancer Center at North Kansas City Hospital
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Rolla, Missouri, Stany Zjednoczone, 65401
- Delbert Day Cancer Institute at PCRMC
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Saint Joseph, Missouri, Stany Zjednoczone, 64506
- Heartland Regional Medical Center
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Springfield, Missouri, Stany Zjednoczone, 65807
- CoxHealth South Hospital
-
Springfield, Missouri, Stany Zjednoczone, 65804
- Mercy Hospital Springfield
-
St Louis, Missouri, Stany Zjednoczone, 63131
- Missouri Baptist Medical Center
-
St Louis, Missouri, Stany Zjednoczone, 63141
- Mercy Hospital Saint Louis
-
St Louis, Missouri, Stany Zjednoczone, 63128
- Mercy Hospital South
-
St Louis, Missouri, Stany Zjednoczone, 63109
- Saint Louis Cancer and Breast Institute-South City
-
Sunset Hills, Missouri, Stany Zjednoczone, 63127
- Missouri Baptist Outpatient Center-Sunset Hills
-
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Montana
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Billings, Montana, Stany Zjednoczone, 59101
- Billings Clinic Cancer Center
-
Bozeman, Montana, Stany Zjednoczone, 59715
- Bozeman Deaconess Hospital
-
-
Nebraska
-
Kearney, Nebraska, Stany Zjednoczone, 68847
- CHI Health Good Samaritan
-
-
Nevada
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Henderson, Nevada, Stany Zjednoczone, 89052
- OptumCare Cancer Care at Seven Hills
-
Las Vegas, Nevada, Stany Zjednoczone, 89102
- OptumCare Cancer Care at Charleston
-
Las Vegas, Nevada, Stany Zjednoczone, 89128
- OptumCare Cancer Care at MountainView
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Las Vegas, Nevada, Stany Zjednoczone, 89148
- OptumCare Cancer Care at Fort Apache
-
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New Jersey
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Hackettstown, New Jersey, Stany Zjednoczone, 07840
- Hackettstown Medical Center
-
Morristown, New Jersey, Stany Zjednoczone, 07960
- Morristown Medical Center
-
Newton, New Jersey, Stany Zjednoczone, 07860
- Newton Medical Center
-
Summit, New Jersey, Stany Zjednoczone, 07902
- Overlook Hospital
-
-
New Mexico
-
Albuquerque, New Mexico, Stany Zjednoczone, 87102
- University of New Mexico Cancer Center
-
Albuquerque, New Mexico, Stany Zjednoczone, 87102
- Lovelace Medical Center-Saint Joseph Square
-
Albuquerque, New Mexico, Stany Zjednoczone, 87109
- Lovelace Radiation Oncology
-
Albuquerque, New Mexico, Stany Zjednoczone, 87109
- Lovelace Women's Hospital
-
Las Cruces, New Mexico, Stany Zjednoczone, 88011
- Memorial Medical Center - Las Cruces
-
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New York
-
Binghamton, New York, Stany Zjednoczone, 13905
- Lourdes Hospital
-
Lake Success, New York, Stany Zjednoczone, 11042
- Northwell Health/Center for Advanced Medicine
-
New York, New York, Stany Zjednoczone, 10032
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
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The Bronx, New York, Stany Zjednoczone, 10461
- Montefiore Medical Center-Einstein Campus
-
The Bronx, New York, Stany Zjednoczone, 10467
- Montefiore Medical Center - Moses Campus
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North Carolina
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Asheboro, North Carolina, Stany Zjednoczone, 27203
- Randolph Hospital
-
Burlington, North Carolina, Stany Zjednoczone, 27215
- Cone Health Cancer Center at Alamance Regional
-
Gastonia, North Carolina, Stany Zjednoczone, 28054
- CaroMont Regional Medical Center
-
Greensboro, North Carolina, Stany Zjednoczone, 27403
- Cone Health Cancer Center
-
Mebane, North Carolina, Stany Zjednoczone, 27302
- Cone Heath Cancer Center at Mebane
-
Reidsville, North Carolina, Stany Zjednoczone, 27320
- Annie Penn Memorial Hospital
-
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North Dakota
-
Fargo, North Dakota, Stany Zjednoczone, 58103
- Essentia Health Cancer Center-South University Clinic
-
Jamestown, North Dakota, Stany Zjednoczone, 58401
- Essentia Health - Jamestown Clinic
-
-
Ohio
-
Belpre, Ohio, Stany Zjednoczone, 45714
- Strecker Cancer Center-Belpre
-
Cincinnati, Ohio, Stany Zjednoczone, 45220
- Good Samaritan Hospital - Cincinnati
-
Columbus, Ohio, Stany Zjednoczone, 43214
- Columbus Oncology and Hematology Associates Inc
-
Delaware, Ohio, Stany Zjednoczone, 43015
- Delaware Health Center-Grady Cancer Center
-
Findlay, Ohio, Stany Zjednoczone, 45840
- Armes Family Cancer Center
-
Mansfield, Ohio, Stany Zjednoczone, 44903
- OhioHealth Mansfield Hospital
-
Mount Vernon, Ohio, Stany Zjednoczone, 43050
- Knox Community Hospital
-
Perrysburg, Ohio, Stany Zjednoczone, 43551
- Mercy Health Perrysburg Cancer Center
-
Toledo, Ohio, Stany Zjednoczone, 43623
- Mercy Health - Saint Anne Hospital
-
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Oklahoma
-
Oklahoma City, Oklahoma, Stany Zjednoczone, 73120
- Mercy Hospital Oklahoma City
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-
Oregon
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Portland, Oregon, Stany Zjednoczone, 97227
- Kaiser Permanente Northwest
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Pennsylvania
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Hazleton, Pennsylvania, Stany Zjednoczone, 18201
- Geisinger Medical Center-Cancer Center Hazleton
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Pottsville, Pennsylvania, Stany Zjednoczone, 17901
- Geisinger Cancer Services-Pottsville
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Wilkes-Barre, Pennsylvania, Stany Zjednoczone, 18711
- Geisinger Wyoming Valley/Henry Cancer Center
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South Carolina
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Bluffton, South Carolina, Stany Zjednoczone, 29910
- Saint Joseph's/Candler - Bluffton Campus
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Boiling Springs, South Carolina, Stany Zjednoczone, 29316
- Prisma Health Cancer Institute - Spartanburg
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Charleston, South Carolina, Stany Zjednoczone, 29425
- Medical University of South Carolina
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Easley, South Carolina, Stany Zjednoczone, 29640
- Prisma Health Cancer Institute - Easley
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Gaffney, South Carolina, Stany Zjednoczone, 29341
- Gibbs Cancer Center-Gaffney
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Georgetown, South Carolina, Stany Zjednoczone, 29440
- Tidelands Georgetown Memorial Hospital
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Georgetown, South Carolina, Stany Zjednoczone, 29440
- Waccamaw Oncology - Georgetown
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Greenville, South Carolina, Stany Zjednoczone, 29605
- Prisma Health Cancer Institute - Faris
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Greenville, South Carolina, Stany Zjednoczone, 29615
- Prisma Health Cancer Institute - Eastside
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Greenville, South Carolina, Stany Zjednoczone, 29605
- Prisma Health Cancer Institute - Butternut
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Greenville, South Carolina, Stany Zjednoczone, 29605
- Prisma Health Greenville Memorial Hospital
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Greenwood, South Carolina, Stany Zjednoczone, 29646
- Self Regional Healthcare
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Greer, South Carolina, Stany Zjednoczone, 29650
- Prisma Health Cancer Institute - Greer
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Greer, South Carolina, Stany Zjednoczone, 29651
- Gibbs Cancer Center-Pelham
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Murrells Inlet, South Carolina, Stany Zjednoczone, 29576
- Waccamaw Oncology-Murrells Inlet
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Myrtle Beach, South Carolina, Stany Zjednoczone, 29577
- Waccamaw Oncology-Myrtle Beach
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Seneca, South Carolina, Stany Zjednoczone, 29672
- Prisma Health Cancer Institute - Seneca
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Spartanburg, South Carolina, Stany Zjednoczone, 29303
- Spartanburg Medical Center
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Union, South Carolina, Stany Zjednoczone, 29379
- MGC Hematology Oncology-Union
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Tennessee
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Kingsport, Tennessee, Stany Zjednoczone, 37660
- Ballad Health Cancer Care - Kingsport
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Nashville, Tennessee, Stany Zjednoczone, 37232
- Vanderbilt University/Ingram Cancer Center
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Virginia
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Bristol, Virginia, Stany Zjednoczone, 24201
- Wellmont Medical Associates-Bristol
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Mechanicsville, Virginia, Stany Zjednoczone, 23116
- Bon Secours Memorial Regional Medical Center
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Midlothian, Virginia, Stany Zjednoczone, 23114
- Bon Secours Saint Francis Medical Center
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Richmond, Virginia, Stany Zjednoczone, 23235
- VCU Massey Cancer Center at Stony Point
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Richmond, Virginia, Stany Zjednoczone, 23298
- Virginia Commonwealth University/Massey Cancer Center
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Richmond, Virginia, Stany Zjednoczone, 23226
- Bon Secours Saint Mary's Hospital
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South Hill, Virginia, Stany Zjednoczone, 23970
- VCU Community Memorial Health Center
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Washington
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Bellingham, Washington, Stany Zjednoczone, 98225
- PeaceHealth Saint Joseph Medical Center
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Edmonds, Washington, Stany Zjednoczone, 98026
- Swedish Cancer Institute-Edmonds
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Issaquah, Washington, Stany Zjednoczone, 98029
- Swedish Cancer Institute-Issaquah
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Lacey, Washington, Stany Zjednoczone, 98503
- Providence Regional Cancer System-Lacey
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Port Townsend, Washington, Stany Zjednoczone, 98368
- Jefferson Healthcare
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Renton, Washington, Stany Zjednoczone, 98055
- Valley Medical Center
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Seattle, Washington, Stany Zjednoczone, 98122
- Swedish Medical Center-First Hill
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Sedro-Woolley, Washington, Stany Zjednoczone, 98284
- PeaceHealth United General Medical Center
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Wisconsin
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Appleton, Wisconsin, Stany Zjednoczone, 54911
- ThedaCare Regional Cancer Center
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Eau Claire, Wisconsin, Stany Zjednoczone, 54701
- HSHS Sacred Heart Hospital
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Green Bay, Wisconsin, Stany Zjednoczone, 54301
- Saint Vincent Hospital Cancer Center Green Bay
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Green Bay, Wisconsin, Stany Zjednoczone, 54303
- Saint Vincent Hospital Cancer Center at Saint Mary's
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New Richmond, Wisconsin, Stany Zjednoczone, 54017
- Cancer Center of Western Wisconsin
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Oconto Falls, Wisconsin, Stany Zjednoczone, 54154
- Saint Vincent Hospital Cancer Center at Oconto Falls
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Sturgeon Bay, Wisconsin, Stany Zjednoczone, 54235-1495
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
-
Patients must have a diagnosis of a metastatic solid tumor or a hematologic malignancy and must receive anti-cancer treatment (i.e. chemotherapy, hormonal therapy, targeted therapy, biologic therapy, immune therapy, bone marrow transplant). Registration must occur within 180 days after diagnosis of metastatic or stage IV solid tumor or treatment-requiring hematologic malignancy. Patients with indolent hematologic diseases undergoing observation alone are not eligible; patients with previously diagnosed hematologic cancers progressed to the point of requiring systemic therapy are eligible, so long as the progression occurred within the previous 180 days. Biopsy confirmation of metastatic disease is not required
-
Patients with recurrent solid tumors will be allowed as long as 1) this is the first presentation of metastatic disease and 2) the diagnosis of the metastasis is at least 180 days (6 months) after the diagnosis date of the previous earlier stage cancer
-
Patients with a history of secondary malignancy are allowed as long as they were not diagnosed within the previous 24 months, are not on active therapy, and are disease-free. Patients with adequately treated basal cell or squamous cell skin cancer, and in situ cervical cancer at any point prior to enrollment are eligible
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Patients who have started anti-cancer treatment for the current diagnosis must have started within 90 days prior to registration
-
Patients who are planning to start anti-cancer treatment for the current diagnosis must start within (=<) 30 days after registration
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Patients are allowed to be co-enrolled on other clinical trials (including non-treatment studies and studies that may or may not include investigational drugs)
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Patients must be at least 18 years of age
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Patients must have a Zubrod performance status of 0-2
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Patients must complete the baseline patient reported outcomes (PRO) questionnaires prior to registration and must be able to complete questionnaires in English or Spanish
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Patients must provide their full name, primary address in the United States (U.S.), birth date and social security number at registration for the purposes of accessing credit report data. (This may be obtained directly from the patient, study questionnaires, or the medical record)
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Patients must provide email and/or telephone number for the purposes of being contacted by financial navigators Spouse/partner caregiver participation is optional.
-
Spouse/partner caregiver must be living in the same household as the eligible patient and be either legally married, in a common law marriage, or be an intimate partner/significant other of the participant*
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Spouse/partner caregivers must be at least 18 years of age
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Spouse/partner caregivers must provide their full name, primary address in the U.S., birth date and social security number at registration for the purposes of accessing credit report data
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Spouse/partner caregivers must provide email and/or telephone number for the purposes of being contacted by the financial navigators
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Spouse/partner caregivers must be able to complete questionnaires in English or Spanish and must complete the baseline questionnaires prior to patient registration
*The study team acknowledges that other types of caregivers may also face financial hardship following a patient's cancer diagnosis and may similarly benefit from financial education and navigation. The decision to focus solely on spouse or partner caregivers was scientific, to understand how caregivers who share household finances experience financial hardship.
-
Participants (patients and caregivers, when participating) must sign and give written informed consent in accordance with institutional and federal guidelines. Use of legally-authorized representative is not permissible for this study. Documentation of informed consent via remote consent is permissible
-
As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Exclusion Criteria:
- Patients may not be enrolled in hospice care at the time of registration
- Non-spouse/partner caregivers such as friends, adult children, parents, or other relatives living in the same household as the patient are not eligible
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
|
Aktywny komparator: Group I (usual care)
Patients receive financial literacy training consisting of watching online educational videos over 2-8 minutes. Patients also complete questionnaires over 30-60 minutes about education, employment, finances (assets, debt), insurance, and quality of life (financial worry) and have credit reports assessed at baseline and 3, 6, and 12 months. If participating, spouse/partner caregivers will receive the same intervention, and will complete questionnaires and have credit reports assessed at baseline and 3, 6, and 12 months. |
Ancillary studies
Inne nazwy:
Complete questionnaires Watch online educational videos
Inne nazwy:
|
|
Eksperymentalny: Group II (financial navigation intervention)
Patients receive financial literacy training consisting of watching online educational videos over 2-8 minutes. Patients also meet with CENTS counselor and PAF case manager over approximately 1 hour every month for 6 months (with each group). Patients also complete questionnaires over 30-60 minutes about education, employment, finances (assets, debt), insurance, and quality of life (financial worry) and have credit reports assessed at baseline and 3, 6, and 12 months. If participating, spouse/partner caregivers will receive the same intervention, and will complete questionnaires and have credit reports assessed at baseline and 3, 6, and 12 months. |
Ancillary studies
Inne nazwy:
Complete questionnaires Watch online educational videos
Inne nazwy:
Meet with CENTS counselor and PAF case manager
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Patient financial hardship
Ramy czasowe: Up to 12 months
|
Defined as one or more of the following: from the patient's credit report within 12 months: any new loans (bank or home equity); exhausting lines of credit by reaching limits on credit cards and home equity loans; credit or other payment delinquencies; becoming subject to a lien, judgment, or other collection process; personal bankruptcy filings. Will conduct a multivariable logistic regression (outcome = patient financial hardship; independent variable = intervention versus [vs.] control), adjusting for demographic, clinical, financial and practice characteristics. |
Up to 12 months
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Quality of life: patient
Ramy czasowe: Up to 12 months
|
As measured by composite European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L). The proportion of patients in each arm who experience improved, unchanged, or worsened EQ-5D scores from baseline to 3, 6 (and 12) months will be compared using Fisher's exact test. Mean score changes will be compared using two group t tests. A multivariate linear regression model, with worsening score as the dependent variable and study arm as the independent variable will be performed. |
Up to 12 months
|
|
Financial worry
Ramy czasowe: Up to 12 months
|
Will be measured by the Comprehensive Score for Financial Toxicity-Patient Reported Outcome Measure (COST-Functional Assessment of Chronic Illness Therapy [FACIT] version 2; Financial Toxicity Scale ranges from 0-44, with higher scores indicating greater financial well-being). Mean scores (and standard deviation [SD]) at 3, 6 and 12 months will be compared between intervention and usual care patients using two sample t tests. |
Up to 12 months
|
|
Treatment adherence: Number of patients
Ramy czasowe: Up to 12 months
|
Number of patients by study arm self-reporting that they did or did not skip medication doses or refuse/decline recommended therapy due to cost concerns. |
Up to 12 months
|
|
Treatment adherence: Proportion of patients
Ramy czasowe: Up to 12 months
|
Proportion of patients by study arm self-reporting that they did or did not skip medication doses or refuse/decline recommended therapy due to cost concerns. |
Up to 12 months
|
|
Emergency department/hospital use
Ramy czasowe: Up to 12 months
|
Will be abstracted from patients' medical records by site staff. Investigators will categorize visits as anticipated (for chemotherapy or planned procedures) versus unanticipated (complication or treatment side-effect). The cumulative incidence of emergency department and unanticipated hospital use will be calculated by arm to account for death as a competing risk and compared using Cox regression, adjusting for covariates. |
Up to 12 months
|
Inne miary wyników
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Spouse/partner caregiver financial hardship
Ramy czasowe: Up to 12 months
|
Defined as one or more of the following: from the spouse/partner caregiver's credit report within 12 months: any new loans (bank or home equity); exhausting lines of credit by reaching limits on credit cards and home equity loans; credit or other payment delinquencies; becoming subject to a lien, judgment, or other collection process; personal bankruptcy filings. Will conduct a multivariable logistic regression (outcome = spouse/partner financial hardship; independent variable = intervention versus [vs.] control), adjusting for demographic, clinical, financial and practice characteristics. |
Up to 12 months
|
|
Spouse/partner caregiver burden
Ramy czasowe: Up to 12 months
|
As measured by the social well-being (Social Concerns, range:0-90, higher scores better) subscale of the City of Hope Quality of Life Family questionnaire. Mean score changes will be compared using two group t tests. A multivariate linear regression model, with worsening score as the dependent variable and study arm as the independent variable will be performed. |
Up to 12 months
|
|
Quality of life: spouse/partner caregiver
Ramy czasowe: Up to 12 months
|
As measured by City of Hope Quality of Life Family subscale scores (Physical Well Being (0-50), Psychological Well Being (0-110); higher scores better). We will determine the proportion of spouse/partner caregivers in each arm who experience improved, unchanged, or worsened Quality of Life Family scores (composite scores for physical, psychological, and social well-being subscales) from baseline to 3, 6 (and 12) months and compare using Fisher's exact test. Mean score changes will be compared using two group t tests. A multivariate linear regression model, with worsening score as the dependent variable and study arm as the independent variable will be performed. |
Up to 12 months
|
|
Community/clinic assistance
Ramy czasowe: Up to 12 months
|
Control arm dyads will be surveyed about availability (or lack), access to, and use of financial assistance via their treating clinic or community-based resources. |
Up to 12 months
|
|
Qualitative assessment of the intervention
Ramy czasowe: Up to 12 months
|
Qualitative Assessment of the Intervention: Intervention arm dyads will be surveyed about availability and use of financial assistance and navigation services with Consumer Education and Training Services (CENTS) and/or Patient Advocate Foundation (PAF). CENTS and PAF will document all interactions with the intervention dyads and specific details about all counseling, assistance, and interventions provided for the dyad over the 6-month intervention period using Medidata Rave. |
Up to 12 months
|
Współpracownicy i badacze
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Śledczy
Śledczy
- Główny śledczy: Veena Shankaran, SWOG Cancer Research Network
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Zakończenie podstawowe
Ukończenie studiów (Rzeczywisty)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Procesy patologiczne
- Nowotwory według lokalizacji
- Nowotwory
- Choroby hematologiczne
- Procesy Nowotworowe
- Stany patologiczne, oznaki i objawy
- Choroby hemowe i limfatyczne
- Nowotwory hematologiczne
- Przerzuty nowotworu
- Administracja usług zdrowotnych
- Techniki śledcze
- Usługi zdrowotne
- Zakłady opieki zdrowotnej i usługi
- Usługi zdrowia dzieci
- Community Health Services
- Pobieżne usługi zdrowotne
- Czynniki społeczno -ekonomiczne
- Charakterystyka populacji
- Zarządzanie opieką nad pacjentem
- Kompleksowa opieka zdrowotna
- Opieka skoncentrowana na pacjencie
- Podstawowa opieka zdrowotna
- Metody
- Wczesna interwencja, edukacja
- Status edukacyjny
- Nawigacja pacjentów
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- S1912CD
- UG1CA189974 (Grant/umowa NIH USA)
- S1912CD (Inny identyfikator: CTEP)
- NCI-2021-00579 (Identyfikator rejestru: CTRP (Clinical Trial Reporting Program))
- SWOG-S1912CD (Inny identyfikator: DCP)
- R01CA248656 (Grant/umowa NIH USA)
- S1912CD (Inny identyfikator: SWOG)
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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