Brief 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.
Brief Title
Financial Navigation Program to Improve Understanding and Management of Financial Aspects of Cancer Care for Patients and Their Spouses
Detailed 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.
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Hematopoietic and Lymphoid Cell Neoplasm
Metastatic Malignant Solid Neoplasm
Recurrent Malignant Solid Neoplasm
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04960787
Org Class
Network
Org Full Name
SWOG Cancer Research Network
Org Study Id
S1912CD
Overall Status
Active, not recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Randomized Trial Addressing Cancer-Related Financial Hardship Through Delivery of a Proactive Financial Navigation Intervention (CREDIT)
Primary Outcomes
Outcome Description
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.
Outcome Measure
Patient financial hardship
Outcome Time Frame
Up to 12 months
Secondary Ids
Secondary Id
NCI-2021-00579
Secondary Id
S1912CD
Secondary Id
SWOG-S1912CD
Secondary Id
S1912CD
Secondary Id
R01CA248656
Secondary Id
UG1CA189974
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Up to 12 months
Outcome Measure
Quality of life: patient
Outcome Description
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.
Outcome Time Frame
Up to 12 months
Outcome Measure
Financial worry
Outcome Description
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.
Outcome Time Frame
Up to 12 months
Outcome Measure
Treatment adherence: Number of patients
Outcome Description
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.
Outcome Time Frame
Up to 12 months
Outcome Measure
Treatment adherence: Proportion of patients
Outcome Description
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.
Outcome Time Frame
Up to 12 months
Outcome Measure
Emergency department/hospital use
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Bruce Rapkin
Investigator Email
bruce.rapkin@einsteinmed.edu
Investigator Phone
718-920-5663