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Trial record 7 of 54 for:    colon cancer | ( Map: Mississippi, United States )

S1417CD Financial Impact Assessment Tool in Patients With Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02728804
Recruitment Status : Active, not recruiting
First Posted : April 5, 2016
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Tracking Information
First Submitted Date March 30, 2016
First Posted Date April 5, 2016
Last Update Posted Date May 3, 2019
Study Start Date April 2016
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 30, 2016)
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 [ Time Frame: Up to 12 months ]
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%.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02728804 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 3, 2017)
  • Accrual to a prospective-multi-site longitudinal cohort study [ Time Frame: Up to 3 years ]
    Each of the NCORP components (we anticipate 25 NCORP 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
  • Caregiver participation [ Time Frame: Up to 12 months ]
    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.
  • Changes in assets/income/wealth [ Time Frame: Baseline to up to 12 months ]
    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.
  • Changes in health insurance [ Time Frame: Baseline to up to 12 months ]
    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.
  • Credit history (TransUnion) [ Time Frame: Up to 12 months ]
    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.
  • Debt and spending by credit report histories [ Time Frame: Up to 12 months ]
    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.
  • Financial stress (patient, caregiver, or bereaved caregiver) [ Time Frame: Up to 12 months ]
    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.
  • 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 [ Time Frame: Up to 12 months ]
    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
  • 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 [ Time Frame: Up to 12 months ]
    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.
  • Risk factors for financial hardship [ Time Frame: Up to 12 months ]
    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.
Original Secondary Outcome Measures
 (submitted: March 30, 2016)
  • Accrual to a prospective-multi-site longitudinal cohort study [ Time Frame: Up to 3 years ]
    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
  • Caregiver participation [ Time Frame: Up to 12 months ]
    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.
  • Changes in assets/income/wealth [ Time Frame: Baseline to up to 12 months ]
    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.
  • Changes in health insurance [ Time Frame: Baseline to up to 12 months ]
    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.
  • Credit history (TransUnion) [ Time Frame: Up to 12 months ]
    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
  • Debt and spending by credit report histories [ Time Frame: Up to 12 months ]
    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
  • Financial stress (patient, caregiver, or bereaved caregiver) [ Time Frame: Up to 12 months ]
    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.
  • 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 [ Time Frame: Up to 12 months ]
    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
  • 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 [ Time Frame: Up to 12 months ]
    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.
  • Risk factors for financial hardship [ Time Frame: Up to 12 months ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title S1417CD Financial Impact Assessment Tool in Patients With Metastatic Colorectal Cancer
Official Title Implementation of a Prospective Financial Impact Assessment Tool in Patients With Metastatic Colorectal Cancer
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with newly diagnosed metastatic colon or rectal cancer treated at NCORP sites.
Condition
  • Stage IVA Colon Cancer
  • Stage IVA Rectal Cancer
  • Stage IVB Colon Cancer
  • Stage IVB Rectal Cancer
Intervention
  • Other: Quality-of-Life Assessment
    Complete questionnaire
    Other Name: Quality of Life Assessment
  • Other: Questionnaire Administration
    Complete questionnaires
Study Groups/Cohorts Health Services Research (questionnaire administration)
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.
Interventions:
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: May 1, 2019)
380
Original Estimated Enrollment
 (submitted: March 30, 2016)
374
Estimated Study Completion Date August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02728804
Other Study ID Numbers S1417CD
NCI-2015-01885 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
S1417
S1417CD ( Other Identifier: SWOG )
SWOG-S1417CD ( Other Identifier: DCP )
S1417CD ( Other Identifier: CTEP )
UG1CA189974 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Southwest Oncology Group
Study Sponsor Southwest Oncology Group
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Veena Shankaran Southwest Oncology Group
PRS Account Southwest Oncology Group
Verification Date May 2019