Financial Impact Assessment Tool in Patients with Metastatic Colorectal Cancer

Inclusion Criteria

• 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 =< 30 days after registration OR must have been initiated =< 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 * NOTE: It is recommended that patients receive medical 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

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.

III. To profile the magnitude and timing of treatment-related changes in patients’ income, assets, debt, and employment, and to quantify major out-of-pocket expenses during the 12 months following registration.

IV. To explore the extent to which health insurance factors (e.g. high copayments, deductibles, premiums, loss/change of insurance plan) are associated with major financial hardship and treatment non-adherence.

V. To determine feasibility of recruiting primary caregivers and measuring caregiver burden and caregivers’ perceptions about cancer treatment costs.

VI. To determine the feasibility of conducting a prospective-multi-site longitudinal cohort study assessing financial outcomes in patients with mCRC undergoing treatment within the NCORP network.

TERTIARY OBJECTIVES:

I. To obtain objective measures of expenses, debt and credit through linkage with individual patient credit reports (TransUnion) at enrollment (baseline), at 6 months, and end of follow up (12 months).

OUTLINE:

Patients complete questionnaires (including the Baseline, Financial/Employment Impact, Insurance Impact, Quality of Life, and Treatment Perceptions questionnaires) over 30-60 minutes at baseline and at 3, 6, 9, and 12 months. Caregivers complete questionnaires over 30-60 minutes at baseline and at 6 and 12 months.

Trial Phase Phase NA

Trial Type Observational

Lead Organization
SWOG

Principal Investigator
Veena Shankaran

• Primary ID S1417CD
• Secondary IDs NCI-2015-01885, SWOG-S1417CD, S1417
• Clinicaltrials.gov ID NCT02728804