A Randomized Trial Addressing Cancer-Related Financial Hardship Through Delivery of a Proactive Financial Navigation Intervention (CREDIT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 331
- 试验地点
- 266
- 主要终点
- Patient financial hardship
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group II (financial navigation intervention)
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.
干预措施: Questionnaire Administration (Other)
Group I (usual care)
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.
干预措施: Educational Intervention (Other)
Group I (usual care)
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.
干预措施: Quality-of-Life Assessment (Other)
Group I (usual care)
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.
干预措施: Questionnaire Administration (Other)
Group II (financial navigation intervention)
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.
干预措施: Educational Intervention (Other)
Group II (financial navigation intervention)
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.
干预措施: Patient Navigation (Behavioral)
Group II (financial navigation intervention)
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.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Patient financial hardship
时间窗: 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.
次要结局
- Treatment adherence: Proportion of patients(Up to 12 months)
- Quality of life: patient(Up to 12 months)
- Financial worry(Up to 12 months)
- Treatment adherence: Number of patients(Up to 12 months)
- Emergency department/hospital use(Up to 12 months)