Financial Navigation Program to Improve Understanding and Management of Financial Aspects of Cancer Care for Patients and Their Spouses
Overview
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.
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply.
- 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
Key Exclusion Criteria
A patient will not be eligible if any of the following criteria applies
- Patients may not be enrolled in hospice care at the time of registration
Learn More
To learn more, visit ClinicalTrials.Gov
Study Type
Phase II/III
Sponsor(s)
Southwest Oncology Group
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