Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-29 @ 7:57 PM
Study NCT ID:
NCT02728804
Status:
COMPLETED
Last Update Posted:
2023-01-26
First Post:
2016-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
S1417CD Financial Impact Assessment Tool in Patients With Metastatic Colorectal Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
Study Overview
Official Title:
Implementation of a Prospective Financial Impact Assessment Tool in Patients With Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
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) 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.
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) 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: