N/A
Completed N=380
S1417CD Financial Impact Assessment Tool in Patients With Metastatic Colorectal Cancer
Stage IVA Colon Cancer · Stage IVA Rectal Cancer · Stage IVB Colon Cancer · Stage IVB Rectal Cancer
Source: ClinicalTrials.gov NCT02728804 ↗
Enrolled (actual)
380
Serious AEs
—
Results posted
Jan 2023
Primary outcomePrimary: Cumulative Incidence Rate of Treatment-related Major Financial Hardship — 71.3; 57.6; 26.6; 26.0 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Incidence Rate of Treatment-related Major Financial Hardship |
71.3; 57.6; 26.6; 26.0; 3.4; 2.6 | — |
| SECONDARY Association of Age and Cumulative Incidence Rate of Major Financial Hardship |
73.7; 68.1 | 0.65 |
| SECONDARY Association of Race and Cumulative Incidence Rate of Major Financial Hardship |
70.3; 73.9 | 0.70 |
| SECONDARY Association of Marital Status and Cumulative Incidence Rate of Major Financial Hardship |
69.0; 72.2 | 0.87 |
| SECONDARY Association of Employment Status and Cumulative Incidence Rate of Major Financial Hardship |
62.9; 76.2 | 0.01 sig |
| SECONDARY Association of Income and Cumulative Incidence Rate of Major Financial Hardship |
72.7; 69.1; 72.9; 64.9 | 0.10 |
| SECONDARY 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 |
— | — |
| SECONDARY Changes in Assets/Income/Wealth |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY Changes in Health Insurance |
— | — |
| SECONDARY Caregiver Participation |
— | — |
| SECONDARY Accrual to a Prospective-multi-site Longitudinal Cohort Study |
— | — |
| SECONDARY Debt and Spending by Credit Report Histories |
— | — |
| SECONDARY Credit History (TransUnion) |
— | — |
| SECONDARY Financial Stress (Patient, Caregiver, or Bereaved Caregiver) |
— | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT02728804). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.