Hematopoietic and Lymphoid Cell NeoplasmCREDITNCT04960787
Financial Navigation Program to Improve Understanding and Management of Financial Aspects of Cancer Care for Patients and Their Spouses
A study testing Educational Intervention, Patient Navigation and Quality-of-Life Assessment in people with Hematopoietic and Lymphoid Cell Neoplasm and Metastatic Malignant Solid Neoplasm, run by SWOG Cancer Research Network at 266 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm
- What is being tested?
- Educational Intervention, Patient Navigation and Quality-of-Life Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 266 sitesin 2 countries
- Study dates
- 12 Oct 2021to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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
- 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
- Patients must have a Zubrod performance status of 0-2
- Patients must complete the baseline patient reported outcomes (PRO) questionnaires prior to registration and must be able to complete questionnaires in English or Spanish
- 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)
- 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*
- Spouse/partner caregivers must be at least 18 years of age
- 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
- Spouse/partner caregivers must provide email and/or telephone number for the purposes of being contacted by the financial navigators
- 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
Who cannot join
- 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
Trial locations and contacts
266 sites in 2 countries.
266 sites in 2 countries
United States264 sites
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
Lovelace Medical Center-Saint Joseph Square
Albuquerque, New Mexico, 87102
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102
Lovelace Radiation Oncology
Albuquerque, New Mexico, 87109
Lovelace Women's Hospital
Albuquerque, New Mexico, 87109
Saint Anthony's Health
Alton, Illinois, 62002
Mary Greeley Medical Center
Ames, Iowa, 50010
McFarland Clinic - Ames
Ames, Iowa, 50010
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Randolph Hospital
Asheboro, North Carolina, 27203
Augusta University Medical Center
Augusta, Georgia, 30912
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012
Rush - Copley Medical Center
Aurora, Illinois, 60504
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, 63011
Flaget Memorial Hospital
Bardstown, Kentucky, 40004
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, 70809
Our Lady of the Lake Physicians Group - Medical Oncology
Baton Rouge, Louisiana, 70809
Louisiana Hematology Oncology Associates
Baton Rouge, Louisiana, 70817
Our Lady of the Lake Medical Oncology
Baton Rouge, Louisiana, 70817
Bronson Battle Creek
Battle Creek, Michigan, 49017
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
Biddeford, Maine, 04005
Billings Clinic Cancer Center
Billings, Montana, 59101
Lourdes Hospital
Binghamton, New York, 13905
Bromenn Lifecare Center
Bloomington, Illinois, 61701
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina, 29910
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
McFarland Clinic - Boone
Boone, Iowa, 50036
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304
Bozeman Deaconess Hospital
Bozeman, Montana, 59715
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Saint Joseph Mercy Brighton
Brighton, Michigan, 48114
Wellmont Medical Associates-Bristol
Bristol, Virginia, 24201
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, 27215
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Illinois CancerCare-Canton
Canton, Illinois, 61520
Saint Joseph Mercy Canton
Canton, Michigan, 48188
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, 80112
Centralia Oncology Clinic
Centralia, Illinois, 62801
Medical University of South Carolina
Charleston, South Carolina, 29425
Saint Joseph Mercy Chelsea
Chelsea, Michigan, 48118
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
John B Amos Cancer Center
Columbus, Georgia, 31904
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
Mercy Hospital
Coon Rapids, Minnesota, 55433
Carle at The Riverfront
Danville, Illinois, 61832
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
Kaiser Permanente-Franklin
Denver, Colorado, 80205
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Epic Care-Dublin
Dublin, California, 94568
Kaiser Permanente Dublin
Dublin, California, 94568
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, 54701
Fairview Southdale Hospital
Edina, Minnesota, 55435
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Crossroads Cancer Center
Effingham, Illinois, 62401
Epic Care Partners in Cancer Care
Emeryville, California, 94608
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, 80113
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Armes Family Cancer Center
Findlay, Ohio, 45840
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan, 48503
Genesee Hematology Oncology PC
Flint, Michigan, 48503
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Essentia Health - Fosston
Fosston, Minnesota, 56542
Beebe South Coastal Health Campus
Frankford, Delaware, 19945
Kaiser Permanente-Fremont
Fremont, California, 94538
Kaiser Permanente-Fresno
Fresno, California, 93720
Unity Hospital
Fridley, Minnesota, 55432
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846
CaroMont Regional Medical Center
Gastonia, North Carolina, 28054
Tidelands Georgetown Memorial Hospital
Georgetown, South Carolina, 29440
Waccamaw Oncology - Georgetown
Georgetown, South Carolina, 29440
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
Cone Health Cancer Center
Greensboro, North Carolina, 27403
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Self Regional Healthcare
Greenwood, South Carolina, 29646
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
Hackettstown Medical Center
Hackettstown, New Jersey, 07840
HaysMed University of Kansas Health System
Hays, Kansas, 67601
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
Queen's Medical Center
Honolulu, Hawaii, 96813
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Essentia Health - Jamestown Clinic
Jamestown, North Dakota, 58401
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129
Freeman Health System
Joplin, Missouri, 64804
Mercy Hospital Joplin
Joplin, Missouri, 64804
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Truman Medical Centers
Kansas City, Missouri, 64108
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
CHI Health Good Samaritan
Kearney, Nebraska, 68847
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Ballad Health Cancer Care - Kingsport
Kingsport, Tennessee, 37660
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503
Kaiser Permanente-Rock Creek
Lafayette, Colorado, 80026
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, 80228
Memorial Medical Center - Las Cruces
Las Cruces, New Mexico, 88011
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, 89128
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148
Lawrence Memorial Hospital
Lawrence, Kansas, 66044
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, 40504
Saint Joseph Hospital East
Lexington, Kentucky, 40509
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, 80120
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Saint Joseph London
London, Kentucky, 40741
Kaiser Permanente-Lone Tree
Lone Tree, Colorado, 80124
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
OhioHealth Mansfield Hospital
Mansfield, Ohio, 44903
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158
Contra Costa Regional Medical Center
Martinez, California, 94553-3156
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Cone Heath Cancer Center at Mebane
Mebane, North Carolina, 27302
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, 23116
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Kaiser Permanente-Modesto
Modesto, California, 95356
Monticello Cancer Center
Monticello, Minnesota, 55362
Morristown Medical Center
Morristown, New Jersey, 07960
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864
Knox Community Hospital
Mount Vernon, Ohio, 43050
Waccamaw Oncology-Murrells Inlet
Murrells Inlet, South Carolina, 29576
Waccamaw Oncology-Myrtle Beach
Myrtle Beach, South Carolina, 29577
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
New Ulm Medical Center
New Ulm, Minnesota, 56073
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Helen F Graham Cancer Center
Newark, Delaware, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Newton Medical Center
Newton, New Jersey, 07860
Bromenn Regional Medical Center
Normal, Illinois, 61761
Carle Cancer Institute Normal
Normal, Illinois, 61761
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri, 64116
Stephens Memorial Hospital
Norway, Maine, 04268
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Kaiser Permanente-Oakland
Oakland, California, 94611
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120
Olathe Health Cancer Center
Olathe, Kansas, 66061
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, 66211
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Mercy Health Perrysburg Cancer Center
Perrysburg, Ohio, 43551
Illinois CancerCare-Peru
Peru, Illinois, 61354
Ascension Via Christi - Pittsburg
Pittsburg, Kansas, 66762
Jefferson Healthcare
Port Townsend, Washington, 98368
Kaiser Permanente Northwest
Portland, Oregon, 97227
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Kaiser Permanente- Marshall Medical Offices
Redwood City, California, 94063
Spectrum Health Reed City Hospital
Reed City, Michigan, 49677
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
Annie Penn Memorial Hospital
Reidsville, North Carolina, 27320
Valley Medical Center
Renton, Washington, 98055
Kaiser Permanente-Richmond
Richmond, California, 94801
Bon Secours Saint Mary's Hospital
Richmond, Virginia, 23226
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401
Kaiser Permanente-Roseville
Roseville, California, 95661
Kaiser Permanente Downtown Commons
Sacramento, California, 95814
Kaiser Permanente-South Sacramento
Sacramento, California, 95823
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Regions Hospital
Saint Paul, Minnesota, 55101
Salina Regional Health Center
Salina, Kansas, 67401
Kaiser Permanente-San Francisco
San Francisco, California, 94115
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119
Kaiser Permanente San Leandro
San Leandro, California, 94577
Kaiser San Rafael-Gallinas
San Rafael, California, 94903
MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
Sanford, Maine, 04073
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403
Memorial Health University Medical Center
Savannah, Georgia, 31404
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405
Maine Medical Center- Scarborough Campus
Scarborough, Maine, 04074
Swedish Medical Center-First Hill
Seattle, Washington, 98122
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, 98284
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103
VCU Community Memorial Health Center
South Hill, Virginia, 23970
Maine Medical Partners - South Portland
South Portland, Maine, 04106
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Springfield Clinic
Springfield, Illinois, 62702
Memorial Medical Center
Springfield, Illinois, 62781
Mercy Hospital Springfield
Springfield, Missouri, 65804
CoxHealth South Hospital
Springfield, Missouri, 65807
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, 63109
Mercy Hospital South
St Louis, Missouri, 63128
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Lakeview Hospital
Stillwater, Minnesota, 55082
Kaiser Permanente-Stockton
Stockton, California, 95210
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495
Overlook Hospital
Summit, New Jersey, 07902
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, 63127
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, 80260
Mercy Health - Saint Anne Hospital
Toledo, Ohio, 43623
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606
Munson Medical Center
Traverse City, Michigan, 49684
MGC Hematology Oncology-Union
Union, South Carolina, 29379
Carle Cancer Center
Urbana, Illinois, 61801
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, 95688
Kaiser Permanente-Vallejo
Vallejo, California, 94589
Ridgeview Medical Center
Waconia, Minnesota, 55387
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596
Epic Care Cyberknife Center
Walnut Creek, California, 94597
Illinois CancerCare - Washington
Washington, Illinois, 61571
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
Rice Memorial Hospital
Willmar, Minnesota, 56201
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092
Rush-Copley Healthcare Center
Yorkville, Illinois, 60560
Puerto Rico2 sites
Doctors Cancer Center
Manati, 00674
Centro Comprensivo de Cancer de UPR
San Juan, 00927
About this study
Official title: A Randomized Trial Addressing Cancer-Related Financial Hardship Through Delivery of a Proactive Financial Navigation Intervention (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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm
- Being tested
- Educational Intervention, Patient Navigation, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Hematologic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Watch online educational videos
Patient NavigationBehavioural
Also called Patient Navigator Program
Meet with CENTS counselor and PAF case manager
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Group I (usual care) | Active comparator | 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. Receives: Other: Educational Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Group II (financial navigation intervention) | Experimental | 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. Receives: Other: Educational Intervention; Behavioral: Patient Navigation; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient financial hardship
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.
Measured: Up to 12 months
Secondary outcomes (5)
Quality of life: patient
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.
Measured: Up to 12 months
Financial worry
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.
Measured: Up to 12 months
Treatment adherence: Number of patients
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.
Measured: Up to 12 months
Treatment adherence: Proportion of patients
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.
Measured: Up to 12 months
Emergency department/hospital use
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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start12 Oct 2021
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Veena Shankaran, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960787
- Sponsor's protocol ID
- S1912CD
- Other IDs
- NCI-2021-00579, S1912CD, SWOG-S1912CD, S1912CD, R01CA248656, UG1CA189974
- Acronym
- CREDIT
- Status last verified
- May 2026
- First submitted
- 8 Jun 2021
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Knight TG, Hensel C, Blackley K, Wheeler M, Warden HR, Turan WJ, Moroe J, Chai S, Feild D, Mesa R, Raghavan D. The Financial Toxicity Tumor Board: 5-Year Update on Practice and a Guide to Implementation. J Natl Compr Canc Netw. 2025 Apr 16;23(5):164-168. doi: 10.6004/jnccn.2025.7010.
PubMed 40239697
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Addressing Cancer-Related Financial Hardship Through Delivery of a Proactive Financial Navigation Intervention (CREDIT)
- ClinicalTrials.gov ID
- NCT04960787
- Acronym / sponsor ID
- CREDIT / S1912CD
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 331 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (usual care) | Active comparator | Other: Educational Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
| Group II (financial navigation intervention) | Experimental | Other: Educational Intervention, Behavioral: Patient Navigation, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalWatch online educational videos | Other | Group I (usual care), Group II (financial navigation intervention) |
| Patient NavigationAlso: Patient Navigator ProgramMeet with CENTS counselor and PAF case manager | Behavioural | Group II (financial navigation intervention) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Group I (usual care), Group II (financial navigation intervention) |
| Questionnaire AdministrationComplete questionnaires | Other | Group I (usual care), Group II (financial navigation intervention) |
Primary outcome
Patient financial hardship
Time frame: 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.
5 secondary outcomes
Quality of life: patient
Time frame: Up to 12 months
Financial worry
Time frame: Up to 12 months
Treatment adherence: Number of patients
Time frame: Up to 12 months
Treatment adherence: Proportion of patients
Time frame: Up to 12 months
Emergency department/hospital use
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Derived from this study: PubMed 40239697Knight TG, Hensel C, Blackley K, Wheeler M, Warden HR, Turan WJ, Moroe J, Chai S, Feild D, Mesa R, Raghavan D. The Financial Toxicity Tumor Board: 5-Year Update on Practice and a Guide to Implementation. J Natl Compr Canc Netw. 2025 Apr 16;23(5):164-168. doi: 10.6004/jnccn.2025.7010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veena Shankaran principal investigator
SWOG Cancer Research Network
266 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Patient Navigation and Quality-of-Life Assessment in people with Hematopoietic and Lymphoid Cell Neoplasm and Metastatic Malignant Solid Neoplasm, run by SWOG Cancer Research Network at 266 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 266 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient financial hardship (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04960787, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.