Implementation of a Prospective Financial Impact Assessment Tool in Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 537
- 主要终点
- Cumulative Incidence Rate of Treatment-related Major Financial Hardship
研究概览
简要总结
This clinical trial studies the use of the financial impact assessment tool in patients with colorectal cancer that has spread from the primary site to other places in the body. Gathering information about patients with colorectal cancer over time may help doctors better understand the financial impact of cancer and help patients avoid financial problems during treatment.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the incidence of treatment-related major financial hardship over 12 months, among patients with newly diagnosed metastatic colorectal cancer (mCRC) treated at components and subcomponents of the National Cancer Institute (NCI) Community Oncology Research Program (NCORP).
SECONDARY OBJECTIVES:
I. To describe the association of major financial hardships with mCRC treatment by demographic factors, including age, race, marital status, employment status, and income.
II. To explore whether occurrence of major financial hardship is associated with poorer health-related quality of life over time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have newly diagnosed metastatic colon or rectal cancer (mCRC) (de novo metastatic diagnosis) or metastatic recurrence after prior treatment for stage I-III disease and be </= 120 days after diagnosis at time of registration
- •Systemic chemotherapy and/or systemic biologic therapy must be planned to be administered within 30 days after registration or must have been initiated within 60 days prior to registration; patients who are planning palliative or hospice care only (no chemotherapy or biologic therapy) are not eligible
- •Registering site must be an NCORP site; it is recommended that patients receive care for the mCRC at the registering site to ensure accessibility of patient records.
- •Patients must be able to complete questionnaires in English
- •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
- •Patients must sign and give written informed consent in accordance with institutional and federal guidelines
- •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
- 未提供
结局指标
主要结局
Cumulative Incidence Rate of Treatment-related Major Financial Hardship
时间窗: Up to 12 months
The cumulative incidence estimates of participants experiencing both major financial hardship (MFH) and multiple financial hardships will be reported. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. A major financial hardship is defined as one or more of the following: debt accumulation of any amount, selling or refinancing home, \>= 20% income decline, borrowing money of any amount from family/friends.
次要结局
- Association of Income and Cumulative Incidence Rate of Major Financial Hardship(Up to 12 months)
- Changes in Assets/Income/Wealth(Baseline to up to 12 months)
- Accrual to a Prospective-multi-site Longitudinal Cohort Study(Up to 3 years)
- Financial Stress (Patient, Caregiver, or Bereaved Caregiver)(Up to 12 months)
- Association of Marital Status and Cumulative Incidence Rate of Major Financial Hardship(Up to 12 months)
- Association of Race and Cumulative Incidence Rate of Major Financial Hardship(Up to 12 months)
- Association of Employment Status and Cumulative Incidence Rate of Major Financial Hardship(Up to 12 months)
- Association of Age and Cumulative Incidence Rate of Major Financial Hardship(Up to 12 months)
- Caregiver Participation(Up to 12 months)
- Health-related Quality of Life (HRQOL) as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Version 3.0(Up to 12 months)
- Out-of-pocket Expenses, Defined as Total Out-of-pocket Direct Medical (e.g., Prescriptions, Physician Visits, Deductibles) and Non-medical (Transportation, Meals) Expenses in the 3 Months Prior to Each Study Visit(Up to 12 months)
- Changes in Health Insurance(Baseline to up to 12 months)
- Debt and Spending by Credit Report Histories(Up to 12 months)
- Credit History (TransUnion)(Up to 12 months)