Financial Navigation Program to Improve Understanding and Management of Financial Aspects of Cancer Care for Patients and Their Spouses

Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial

— CREDIT  

Official title:

A Randomized Trial Addressing Cancer-Related Financial Hardship Through Delivery of a Proactive Financial Navigation Intervention (CREDIT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04960787
• Other study ID #: S1912CD
• Secondary ID: NCI-2021-00579S1
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: October 1, 2026

Study information

• Verified date: May 2024
• Source: SWOG Cancer Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 522
• Est. completion date: October 1, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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
• 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)
• 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

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

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid Cell Neoplasm
• Metastatic Malignant Solid Neoplasm
• Neoplasms
• Recurrent Malignant Solid Neoplasm

Intervention

Other:
• Educational Intervention
Watch online educational videos

Behavioral:
• Patient Navigation
Meet with CENTS counselor and PAF case manager

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
Puerto Rico	Doctors Cancer Center	Manati
Puerto Rico	Centro Comprensivo de Cancer de UPR	San Juan
United States	Hawaii Cancer Care - Westridge	'Aiea	Hawaii
United States	Pali Momi Medical Center	'Aiea	Hawaii
United States	Lovelace Medical Center-Saint Joseph Square	Albuquerque	New Mexico
United States	Lovelace Radiation Oncology	Albuquerque	New Mexico
United States	Lovelace Women's Hospital	Albuquerque	New Mexico
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	Saint Anthony's Health	Alton	Illinois
United States	Mary Greeley Medical Center	Ames	Iowa
United States	McFarland Clinic - Ames	Ames	Iowa
United States	Saint Joseph Mercy Hospital	Ann Arbor	Michigan
United States	Kaiser Permanente-Deer Valley Medical Center	Antioch	California
United States	ThedaCare Regional Cancer Center	Appleton	Wisconsin
United States	Randolph Hospital	Asheboro	North Carolina
United States	Augusta University Medical Center	Augusta	Georgia
United States	Harold Alfond Center for Cancer Care	Augusta	Maine
United States	Rocky Mountain Cancer Centers-Aurora	Aurora	Colorado
United States	Rush - Copley Medical Center	Aurora	Illinois
United States	Saint Louis Cancer and Breast Institute-Ballwin	Ballwin	Missouri
United States	Flaget Memorial Hospital	Bardstown	Kentucky
United States	Louisiana Hematology Oncology Associates	Baton Rouge	Louisiana
United States	Louisiana Hematology Oncology Associates LLC	Baton Rouge	Louisiana
United States	LSU Health Baton Rouge-North Clinic	Baton Rouge	Louisiana
United States	Our Lady of the Lake Medical Oncology	Baton Rouge	Louisiana
United States	Our Lady of the Lake Physicians Group - Medical Oncology	Baton Rouge	Louisiana
United States	Bronson Battle Creek	Battle Creek	Michigan
United States	PeaceHealth Saint Joseph Medical Center	Bellingham	Washington
United States	Strecker Cancer Center-Belpre	Belpre	Ohio
United States	MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford	Biddeford	Maine
United States	Billings Clinic Cancer Center	Billings	Montana
United States	Lourdes Hospital	Binghamton	New York
United States	Bromenn Lifecare Center	Bloomington	Illinois
United States	Illinois CancerCare-Bloomington	Bloomington	Illinois
United States	Saint Joseph's/Candler - Bluffton Campus	Bluffton	South Carolina
United States	Prisma Health Cancer Institute - Spartanburg	Boiling Springs	South Carolina
United States	Central Care Cancer Center - Bolivar	Bolivar	Missouri
United States	McFarland Clinic - Boone	Boone	Iowa
United States	Rocky Mountain Cancer Centers-Boulder	Boulder	Colorado
United States	Bozeman Deaconess Hospital	Bozeman	Montana
United States	Essentia Health Saint Joseph's Medical Center	Brainerd	Minnesota
United States	Saint Joseph Mercy Brighton	Brighton	Michigan
United States	Wellmont Medical Associates-Bristol	Bristol	Virginia
United States	Montefiore Medical Center - Moses Campus	Bronx	New York
United States	Montefiore Medical Center-Einstein Campus	Bronx	New York
United States	Cone Health Cancer Center at Alamance Regional	Burlington	North Carolina
United States	Minnesota Oncology - Burnsville	Burnsville	Minnesota
United States	Illinois CancerCare-Canton	Canton	Illinois
United States	Saint Joseph Mercy Canton	Canton	Michigan
United States	Saint Francis Medical Center	Cape Girardeau	Missouri
United States	Illinois CancerCare-Carthage	Carthage	Illinois
United States	Oncology Associates at Mercy Medical Center	Cedar Rapids	Iowa
United States	Rocky Mountain Cancer Centers - Centennial	Centennial	Colorado
United States	Centralia Oncology Clinic	Centralia	Illinois
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Saint Joseph Mercy Chelsea	Chelsea	Michigan
United States	Good Samaritan Hospital - Cincinnati	Cincinnati	Ohio
United States	Columbus Oncology and Hematology Associates Inc	Columbus	Ohio
United States	John B Amos Cancer Center	Columbus	Georgia
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	Carle at The Riverfront	Danville	Illinois
United States	Cancer Care Specialists of Illinois - Decatur	Decatur	Illinois
United States	Delaware Health Center-Grady Cancer Center	Delaware	Ohio
United States	Kaiser Permanente-Franklin	Denver	Colorado
United States	Rocky Mountain Cancer Centers-Midtown	Denver	Colorado
United States	Rocky Mountain Cancer Centers-Rose	Denver	Colorado
United States	Medical Oncology and Hematology Associates-Des Moines	Des Moines	Iowa
United States	Mercy Medical Center - Des Moines	Des Moines	Iowa
United States	Essentia Health Saint Mary's - Detroit Lakes Clinic	Detroit Lakes	Minnesota
United States	Illinois CancerCare-Dixon	Dixon	Illinois
United States	Epic Care-Dublin	Dublin	California
United States	Kaiser Permanente Dublin	Dublin	California
United States	Essentia Health Cancer Center	Duluth	Minnesota
United States	Prisma Health Cancer Institute - Easley	Easley	South Carolina
United States	HSHS Sacred Heart Hospital	Eau Claire	Wisconsin
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Swedish Cancer Institute-Edmonds	Edmonds	Washington
United States	Crossroads Cancer Center	Effingham	Illinois
United States	Epic Care Partners in Cancer Care	Emeryville	California
United States	Rocky Mountain Cancer Centers - Swedish	Englewood	Colorado
United States	Illinois CancerCare-Eureka	Eureka	Illinois
United States	Fairbanks Memorial Hospital	Fairbanks	Alaska
United States	Essentia Health Cancer Center-South University Clinic	Fargo	North Dakota
United States	Parkland Health Center - Farmington	Farmington	Missouri
United States	Armes Family Cancer Center	Findlay	Ohio
United States	Genesee Cancer and Blood Disease Treatment Center	Flint	Michigan
United States	Genesee Hematology Oncology PC	Flint	Michigan
United States	Genesys Hurley Cancer Institute	Flint	Michigan
United States	McFarland Clinic - Trinity Cancer Center	Fort Dodge	Iowa
United States	Mercy Hospital Fort Smith	Fort Smith	Arkansas
United States	Essentia Health - Fosston	Fosston	Minnesota
United States	Beebe South Coastal Health Campus	Frankford	Delaware
United States	Kaiser Permanente-Fremont	Fremont	California
United States	Kaiser Permanente-Fresno	Fresno	California
United States	Unity Hospital	Fridley	Minnesota
United States	Gibbs Cancer Center-Gaffney	Gaffney	South Carolina
United States	Illinois CancerCare-Galesburg	Galesburg	Illinois
United States	Central Care Cancer Center - Garden City	Garden City	Kansas
United States	CaroMont Regional Medical Center	Gastonia	North Carolina
United States	Tidelands Georgetown Memorial Hospital	Georgetown	South Carolina
United States	Waccamaw Oncology - Georgetown	Georgetown	South Carolina
United States	Spectrum Health at Butterworth Campus	Grand Rapids	Michigan
United States	Trinity Health Grand Rapids Hospital	Grand Rapids	Michigan
United States	Central Care Cancer Center - Great Bend	Great Bend	Kansas
United States	Saint Vincent Hospital Cancer Center at Saint Mary's	Green Bay	Wisconsin
United States	Saint Vincent Hospital Cancer Center Green Bay	Green Bay	Wisconsin
United States	Cone Health Cancer Center	Greensboro	North Carolina
United States	Prisma Health Cancer Institute - Butternut	Greenville	South Carolina
United States	Prisma Health Cancer Institute - Eastside	Greenville	South Carolina
United States	Prisma Health Cancer Institute - Faris	Greenville	South Carolina
United States	Prisma Health Greenville Memorial Hospital	Greenville	South Carolina
United States	Self Regional Healthcare	Greenwood	South Carolina
United States	Gibbs Cancer Center-Pelham	Greer	South Carolina
United States	Prisma Health Cancer Institute - Greer	Greer	South Carolina
United States	Hackettstown Medical Center	Hackettstown	New Jersey
United States	HaysMed University of Kansas Health System	Hays	Kansas
United States	Geisinger Medical Center-Cancer Center Hazleton	Hazleton	Pennsylvania
United States	OptumCare Cancer Care at Seven Hills	Henderson	Nevada
United States	Hawaii Cancer Care Inc - Waterfront Plaza	Honolulu	Hawaii
United States	Kaiser Permanente Moanalua Medical Center	Honolulu	Hawaii
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii
United States	Queen's Medical Center	Honolulu	Hawaii
United States	Straub Clinic and Hospital	Honolulu	Hawaii
United States	University of Hawaii Cancer Center	Honolulu	Hawaii
United States	Swedish Cancer Institute-Issaquah	Issaquah	Washington
United States	Essentia Health - Jamestown Clinic	Jamestown	North Dakota
United States	McFarland Clinic - Jefferson	Jefferson	Iowa
United States	Freeman Health System	Joplin	Missouri
United States	Mercy Hospital Joplin	Joplin	Missouri
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Truman Medical Centers	Kansas City	Missouri
United States	University of Kansas Cancer Center - North	Kansas City	Missouri
United States	CHI Health Good Samaritan	Kearney	Nebraska
United States	Illinois CancerCare-Kewanee Clinic	Kewanee	Illinois
United States	Ballad Health Cancer Care - Kingsport	Kingsport	Tennessee
United States	Providence Regional Cancer System-Lacey	Lacey	Washington
United States	Kaiser Permanente-Rock Creek	Lafayette	Colorado
United States	Northwell Health/Center for Advanced Medicine	Lake Success	New York
United States	Rocky Mountain Cancer Centers-Lakewood	Lakewood	Colorado
United States	Memorial Medical Center - Las Cruces	Las Cruces	New Mexico
United States	OptumCare Cancer Care at Charleston	Las Vegas	Nevada
United States	OptumCare Cancer Care at Fort Apache	Las Vegas	Nevada
United States	OptumCare Cancer Care at MountainView	Las Vegas	Nevada
United States	Lawrence Memorial Hospital	Lawrence	Kansas
United States	University of Kansas Cancer Center - Lee's Summit	Lee's Summit	Missouri
United States	Saint Joseph Hospital East	Lexington	Kentucky
United States	Saint Joseph Radiation Oncology Resource Center	Lexington	Kentucky
United States	Rocky Mountain Cancer Centers-Littleton	Littleton	Colorado
United States	Trinity Health Saint Mary Mercy Livonia Hospital	Livonia	Michigan
United States	Saint Joseph London	London	Kentucky
United States	Kaiser Permanente-Lone Tree	Lone Tree	Colorado
United States	Rocky Mountain Cancer Centers-Sky Ridge	Lone Tree	Colorado
United States	Illinois CancerCare-Macomb	Macomb	Illinois
United States	OhioHealth Mansfield Hospital	Mansfield	Ohio
United States	Fairview Clinics and Surgery Center Maple Grove	Maple Grove	Minnesota
United States	Saint John's Hospital - Healtheast	Maplewood	Minnesota
United States	McFarland Clinic - Marshalltown	Marshalltown	Iowa
United States	Contra Costa Regional Medical Center	Martinez	California
United States	Carle Physician Group-Mattoon/Charleston	Mattoon	Illinois
United States	Cone Heath Cancer Center at Mebane	Mebane	North Carolina
United States	Bon Secours Memorial Regional Medical Center	Mechanicsville	Virginia
United States	Bon Secours Saint Francis Medical Center	Midlothian	Virginia
United States	Abbott-Northwestern Hospital	Minneapolis	Minnesota
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Kaiser Permanente-Modesto	Modesto	California
United States	Monticello Cancer Center	Monticello	Minnesota
United States	Morristown Medical Center	Morristown	New Jersey
United States	Good Samaritan Regional Health Center	Mount Vernon	Illinois
United States	Knox Community Hospital	Mount Vernon	Ohio
United States	Waccamaw Oncology-Murrells Inlet	Murrells Inlet	South Carolina
United States	Waccamaw Oncology-Myrtle Beach	Myrtle Beach	South Carolina
United States	Vanderbilt University/Ingram Cancer Center	Nashville	Tennessee
United States	Cancer Center of Western Wisconsin	New Richmond	Wisconsin
United States	New Ulm Medical Center	New Ulm	Minnesota
United States	NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center	New York	New York
United States	Helen F Graham Cancer Center	Newark	Delaware
United States	Medical Oncology Hematology Consultants PA	Newark	Delaware
United States	Newton Medical Center	Newton	New Jersey
United States	Bromenn Regional Medical Center	Normal	Illinois
United States	Carle Cancer Institute Normal	Normal	Illinois
United States	University of Kansas Cancer Center at North Kansas City Hospital	North Kansas City	Missouri
United States	Stephens Memorial Hospital	Norway	Maine
United States	Cancer Care Center of O'Fallon	O'Fallon	Illinois
United States	Kaiser Permanente-Oakland	Oakland	California
United States	Saint Vincent Hospital Cancer Center at Oconto Falls	Oconto Falls	Wisconsin
United States	Mercy Hospital Oklahoma City	Oklahoma City	Oklahoma
United States	Olathe Health Cancer Center	Olathe	Kansas
United States	Illinois CancerCare-Ottawa Clinic	Ottawa	Illinois
United States	University of Kansas Cancer Center-Overland Park	Overland Park	Kansas
United States	University of Kansas Hospital-Indian Creek Campus	Overland Park	Kansas
United States	Illinois CancerCare-Pekin	Pekin	Illinois
United States	Illinois CancerCare-Peoria	Peoria	Illinois
United States	Mercy Health Perrysburg Cancer Center	Perrysburg	Ohio
United States	Illinois CancerCare-Peru	Peru	Illinois
United States	Ascension Via Christi - Pittsburg	Pittsburg	Kansas
United States	Jefferson Healthcare	Port Townsend	Washington
United States	Kaiser Permanente Northwest	Portland	Oregon
United States	Geisinger Cancer Services-Pottsville	Pottsville	Pennsylvania
United States	Illinois CancerCare-Princeton	Princeton	Illinois
United States	Kaiser Permanente- Marshall Medical Offices	Redwood City	California
United States	Spectrum Health Reed City Hospital	Reed City	Michigan
United States	Beebe Health Campus	Rehoboth Beach	Delaware
United States	Annie Penn Memorial Hospital	Reidsville	North Carolina
United States	Valley Medical Center	Renton	Washington
United States	Bon Secours Saint Mary's Hospital	Richmond	Virginia
United States	Kaiser Permanente-Richmond	Richmond	California
United States	VCU Massey Cancer Center at Stony Point	Richmond	Virginia
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia
United States	Delbert Day Cancer Institute at PCRMC	Rolla	Missouri
United States	Kaiser Permanente-Roseville	Roseville	California
United States	Kaiser Permanente Downtown Commons	Sacramento	California
United States	Kaiser Permanente-South Sacramento	Sacramento	California
United States	Heartland Regional Medical Center	Saint Joseph	Missouri
United States	Mercy Hospital Saint Louis	Saint Louis	Missouri
United States	Mercy Hospital South	Saint Louis	Missouri
United States	Missouri Baptist Medical Center	Saint Louis	Missouri
United States	Saint Louis Cancer and Breast Institute-South City	Saint Louis	Missouri
United States	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota
United States	Regions Hospital	Saint Paul	Minnesota
United States	Salina Regional Health Center	Salina	Kansas
United States	Kaiser Permanente-San Francisco	San Francisco	California
United States	Kaiser Permanente-Santa Teresa-San Jose	San Jose	California
United States	Kaiser Permanente San Leandro	San Leandro	California
United States	Kaiser San Rafael-Gallinas	San Rafael	California
United States	MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford	Sanford	Maine
United States	Kaiser Permanente Medical Center - Santa Clara	Santa Clara	California
United States	Kaiser Permanente-Santa Rosa	Santa Rosa	California
United States	Lewis Cancer and Research Pavilion at Saint Joseph's/Candler	Savannah	Georgia
United States	Memorial Health University Medical Center	Savannah	Georgia
United States	Maine Medical Center- Scarborough Campus	Scarborough	Maine
United States	Swedish Medical Center-First Hill	Seattle	Washington
United States	PeaceHealth United General Medical Center	Sedro-Woolley	Washington
United States	Prisma Health Cancer Institute - Seneca	Seneca	South Carolina
United States	LSU Health Sciences Center at Shreveport	Shreveport	Louisiana
United States	VCU Community Memorial Health Center	South Hill	Virginia
United States	Maine Medical Partners - South Portland	South Portland	Maine
United States	Kaiser Permanente-South San Francisco	South San Francisco	California
United States	Spartanburg Medical Center	Spartanburg	South Carolina
United States	CoxHealth South Hospital	Springfield	Missouri
United States	Memorial Medical Center	Springfield	Illinois
United States	Mercy Hospital Springfield	Springfield	Missouri
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	Springfield Clinic	Springfield	Illinois
United States	Lakeview Hospital	Stillwater	Minnesota
United States	Kaiser Permanente-Stockton	Stockton	California
United States	Saint Vincent Hospital Cancer Center at Sturgeon Bay	Sturgeon Bay	Wisconsin
United States	Overlook Hospital	Summit	New Jersey
United States	Missouri Baptist Outpatient Center-Sunset Hills	Sunset Hills	Missouri
United States	Rocky Mountain Cancer Centers-Thornton	Thornton	Colorado
United States	Mercy Health - Saint Anne Hospital	Toledo	Ohio
United States	University of Kansas Health System Saint Francis Campus	Topeka	Kansas
United States	Munson Medical Center	Traverse City	Michigan
United States	MGC Hematology Oncology-Union	Union	South Carolina
United States	Carle Cancer Center	Urbana	Illinois
United States	Kaiser Permanente Medical Center-Vacaville	Vacaville	California
United States	Kaiser Permanente-Vallejo	Vallejo	California
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	Epic Care Cyberknife Center	Walnut Creek	California
United States	Kaiser Permanente-Walnut Creek	Walnut Creek	California
United States	Illinois CancerCare - Washington	Washington	Illinois
United States	University of Kansas Hospital-Westwood Cancer Center	Westwood	Kansas
United States	Geisinger Wyoming Valley/Henry Cancer Center	Wilkes-Barre	Pennsylvania
United States	Rice Memorial Hospital	Willmar	Minnesota
United States	Minnesota Oncology Hematology PA-Woodbury	Woodbury	Minnesota
United States	Fairview Lakes Medical Center	Wyoming	Minnesota
United States	Rush-Copley Healthcare Center	Yorkville	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
SWOG Cancer Research Network	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Spouse/partner caregiver financial hardship	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
Other	Spouse/partner caregiver burden	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
Other	Quality of life: spouse/partner caregiver	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
Other	Community/clinic assistance	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
Other	Qualitative assessment of the intervention	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
Primary	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	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.	Up to 12 months