Financial Impact Assessment Tool in Patients With Metastatic Colorectal Cancer

Stage IVA Colon Cancer Clinical Trial

Official title:

Implementation of a Prospective Financial Impact Assessment Tool in Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02755571
• Other study ID #: NCI-2015-01885
• Secondary ID: NCI-2015-01885S1
• Status: Not yet recruiting
• Phase: N/A
• First received: April 27, 2016
• Last updated: April 27, 2016
• Start date: July 2016

Study information

• Verified date: November 2015
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 Southwest Oncology Group (SWOG)-affiliated Cancer Care Delivery Research (CCDR) components of the National Cancer Institute (NCI) Community Oncology Research Program (NCORP) sites.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 374
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 within 90 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; patients who have already started treatment or who are planning palliative or hospice care only (no chemotherapy or biologic therapy) are not eligible

• Patients may not be enrolled (or planning enrollment) in a clinical treatment trial at the time of registration

• No prior malignancy other than colorectal carcinoma (CRC) is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for five years

• Patients must plan to receive treatment at the registering site; registering site must be an NCORP CCDR site

• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Rectal Neoplasms
• Stage IVA Colon Cancer
• Stage IVA Rectal Cancer
• Stage IVB Colon Cancer
• Stage IVB Rectal Cancer

Intervention

Other:
• Quality-of-Life Assessment
Complete questionnaire
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	SWOG	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-related major financial hardship, 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	The proportion of patients experiencing multiple financial hardships will also be reported. A sample size of n = 320 eligible, evaluable patients will allow us to estimate the confidence interval to within +/- 8% (based on the upper bound of the 95% confidence interval using an exact binomial in patients with complete follow-up), if he assumed incidence is at least 40%.	Up to 12 months	No
Secondary	Accrual to a prospective-multi-site longitudinal cohort study	Each of the CCDR components (we anticipate 25 CCDR components) will each need to enroll, on average, about 5 patients per year. Accrual will be assessed at 1.5 years after study activation. If monthly average accrual in quarters 5-6 after study registration is < 50% of projected accrual, efforts will be made to increase accrual over the succeeding 6 month period. If after 2 years, monthly accrual remains < 50% of projected accrual, study revision will be considered. In order to address the potential for selection bias, demographics (age, race, gender, etc.) of the final cohort will be compared	Up to 3 years	No
Secondary	Caregiver participation	The caregiver component will be considered feasible if the designated caregivers for > 50% of eligible patients complete and submit their baseline and at least one follow-up assessment. Means, medians, and proportions will be used to describe the participating caregiver population. Analyses will be largely descriptive. If caregiver accrual is very poor (< 20%), describing the patient population will be the focus rather than attempting to correlate caregiver and patient responses.	Up to 12 months	No
Secondary	Changes in assets/income/wealth	Will be handled using descriptive statistics (e.g. mean, median, proportions). Descriptive statistics will be used to summarize baseline patient characteristics and will compare populations using two-sample means and proportions tests (alpha level 0.05). Caregiver strain index will be scored based on responses (score range 0 to 26). Mean scores will be compared for caregivers of patients reporting vs. not reporting at least one financial hardship.	Baseline to up to 12 months	No
Secondary	Changes in health insurance	Will be handled using descriptive statistics (e.g. mean, median, proportions). Descriptive statistics will be used to summarize baseline patient characteristics and will compare populations using two-sample means and proportions tests (alpha level 0.05). Caregiver strain index will be scored based on responses (score range 0 to 26). Mean scores will be compared for caregivers of patients reporting vs. not reporting at least one financial hardship.	Baseline to up to 12 months	No
Secondary	Credit history (TransUnion)	The linkage of SWOG clinical and financial data with credit histories obtained from TransUnion will allow exploration of additional indicators of financial stress, including high balances and past due amounts of credit card and bankcards as well as evidence of bankruptcies, liens, and collections or repossessions in the preceding 36 months (TransUnion Inc. 'Credit Vision' report). This linked database will also provide a more complete picture of patients' pre-diagnosis financial status and post-diagnosis financial hardship. These data will also allow corroboration of self-reports of debt and b	Up to 12 months	No
Secondary	Debt and spending by credit report histories	Credit histories obtained from TransUnion measure the following: non-mortgage amounts past due on credit cards and bankcards; non-mortgage credit card and bankcard balances; bankruptcies, liens, collections or repossessions. Will be handled using descriptive statistics (e.g. mean, median, proportions). Descriptive statistics will be used to summarize baseline patient characteristics and will compare populations using two-sample means and proportions tests (alpha level 0.05). Caregiver strain index will be scored based on responses (score range 0 to 26). Mean scores will be compared for caregiv	Up to 12 months	No
Secondary	Financial stress (patient, caregiver, or bereaved caregiver)	Will be handled using descriptive statistics (e.g. mean, median, proportions). Descriptive statistics will be used to summarize baseline patient characteristics and will compare populations using two-sample means and proportions tests (alpha level 0.05). Caregiver strain index will be scored based on responses (score range 0 to 26). Mean scores will be compared for caregivers of patients reporting vs. not reporting at least one financial hardship.	Up to 12 months	No
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	The relationship between major financial hardship and HRQOL will be assessed. Landmark analysis will be used to establish major financial hardship as a baseline predictor of HRQOL. In particular, patients will be categorized as having major financial hardship at their 3 month assessment (yes vs. no). Linear regression will then be used to assess whether the 3-month assessment of financial hardship predicts the 6-month HRQOL score. HRQOL at 3 months will be included as an adjustment covariate. The 6-month HRQOL score will be based on the EORTC QLQ-C30 questionnaire transformed into a linear sco	Up to 12 months	No
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	Will be handled using descriptive statistics (e.g. mean, median, proportions). Descriptive statistics will be used to summarize baseline patient characteristics and will compare populations using two-sample means and proportions tests (alpha level 0.05). Caregiver strain index will be scored based on responses (score range 0 to 26). Mean scores will be compared for caregivers of patients reporting vs. not reporting at least one financial hardship.	Up to 12 months	No
Secondary	Risk factors for financial hardship	Assess whether major financial hardship at one year differs by age (< 65 versus [vs.] >= 65), race (white vs. non-white), marital status (married vs. unmarried), employment status (any employment vs. unemployed), and income (household income < $50,000/year vs. >= $50,000 / year). The effect of age, race, marital status, employment status, and income on major financial hardship will be estimated using multivariable Cox regression. The regression will include the 5 covariates of interest plus insurance status, education, and gender.	Up to 12 months	No