Purpose

This clinical trial examines a financial navigation program in helping patients and their spouses understand and better manage the financial aspects of cancer care. Cancer patients and their spouses may be at high risk for financial problems because of the cost of cancer treatment. A financial navigator is a person or team who work 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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 120 days after diagnosis. Patients with indolent hematologic diseases undergoing observation alone are not eligible - 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 60 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 telephone number for the purposes of being contacted by financial navigators - Spouse caregiver must be willing to participate in the trial - Spouse caregiver must be legally married, or file their tax returns as married filing jointly - 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 caregivers was scientific, to facilitate analysis of primary endpoint (household financial hardship) - Spouse caregiver must be living in the same household with the eligible patient enrolling in this trial - Spouse caregivers must be at least 18 years of age - Spouse 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 caregivers must provide email and telephone number for the purposes of being contacted by the financial navigators - Spouse caregivers must be able to complete questionnaires in English or Spanish and must complete the baseline questionnaires prior to patient registration - Participants (patients and spouse caregivers) 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Group I (usual care)
Patients and spouse caregivers receive financial literacy training consisting of watching online educational videos over 2-8 minutes. Patients and spouses 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.
  • Other: Educational Intervention
    Watch online educational videos
    Other names:
    • Education for Intervention
    • Intervention by Education
    • Intervention through Education
    • Intervention, Educational
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Complete questionnaires
Experimental
Group II (financial navigation intervention)
Patients and spouse caregivers 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 and spouses 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.
  • Other: Educational Intervention
    Watch online educational videos
    Other names:
    • Education for Intervention
    • Intervention by Education
    • Intervention through Education
    • Intervention, Educational
  • Behavioral: Patient Navigation
    Meet with CENTS counselor and PAF case manager
    Other names:
    • Patient Navigator Program
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Complete questionnaires

Recruiting Locations

University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri 64116
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Cancer Center - North
Kansas City, Missouri 64154
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri 64064
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas 66211
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Cancer Center-Overland Park
Overland Park, Kansas 66210
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Health System Saint Francis Campus
Topeka, Kansas 66606
Contact:
Site Public Contact
785-295-8000

More Details

Status
Recruiting
Sponsor
Southwest Oncology Group

Study Contact

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, and their spouse caregivers. SECONDARY OBJECTIVES: I. To examine whether proactive financial navigation improves patient and/or spouse caregiver quality of life. II. To examine whether proactive financial navigation decreases financial worry among patients and/or spouse caregivers relative to usual care and explore the extent to which financial worry correlates with financial hardship. ADDITIONAL OBJECTIVES: I. 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. II. 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. OUTLINE: Patients and spouses are randomized to 1 of 2 groups. GROUP I: Patients and spouse caregivers receive financial literacy training consisting of watching online educational videos over 2-8 minutes. Patients and spouses 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 and spouse caregivers 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 and spouses 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.