Financial Burden Assessment in Patients With Stage I-III Colon or Rectal Cancer Undergoing Treatment

• ClinicalTrials.gov Identifier: NCT03516942
• Recruitment Status: Active, not recruiting
• First Posted: May 7, 2018
• Last Update Posted: October 29, 2020
• Sponsor: ECOG-ACRIN Cancer Research Group
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

Tracking Information

• First Submitted Date: April 24, 2018
• First Posted Date: May 7, 2018
• Last Update Posted Date: October 29, 2020
• Actual Study Start Date: May 17, 2018
• Estimated Primary Completion Date: September 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 24, 2018)

Change in level of self-reported financial burden [ Time Frame: Baseline to 12 months after cancer diagnosis ]

Will calculate the difference of Comprehensive Score for Financial Toxicity (COST) measurements from baseline to 12-month follow up for the completers who provide data at both time points, and use the paired t-test to assess if the mean difference is significantly different from zero. In case the data are not normally distributed, nonparametric methods (e.g., Wilcoxon signed-rank test) will be used instead to assess the difference. In addition, linear regression models with the change of COST from baseline to 12-month follow up as the response variable will be fit to investigate the impact of other factors, including demographics variables (e.g., age, sex, marital status), clinical variables (e.g., stage of disease, malignancy type, chemotherapy status), baseline questionnaire variables (e.g., self-efficacy,). The three-level treatment status (intravenous [IV] chemotherapy, chemotherapy without IV, and no chemotherapy) will also be evaluated as a predictor.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 7, 2018)

• Reported access and utilization of financial services [ Time Frame: Up to 12 months ]
  Will evaluate reported access and utilization of financial services (i.e. financial counselor, navigator, social workers) and its association to financial burden in the first 12 months after diagnosis of colon or rectal cancer treated with curative-intent. Will be assessed by Consumer Based Cancer Care Value Index (CCVI). For the continuous item variable, will conduct the paired t test to examine the difference if the distribution is normal. If not normally distributed, Wilcoxon signed rank test will be used. For the categorical item variable, the paired proportion test (e.g., McNemar test) will be used instead. The association between CCVI and COST measures will be evaluated using the Pearson or Spearman correlation coefficient.
• Change in level of self-reported financial burden and employment limitations [ Time Frame: Baseline up to 12 months after cancer diagnosis ]
  Will be assessed by Work Productivity and Activity Impairment Questionnaire, Work Ability Index, and Work after cancer survey. If the distributions are normal, will conduct the paired t tests to examine the differences of these variables. If not normally distributed, Wilcoxon signed rank tests will be used. The association with COST measures will be evaluated using the Pearson or Spearman correlation coefficients.
• Long term outcomes [ Time Frame: At 24 months ]
  Will evaluate long term outcomes at 24 months after diagnosis for adherence to clinical follow-up guidelines. Specially, linear (or generalized linear) mixed model will be fit to study the change in the mean response over time. In case the changes in the mean response over time are not linear, the quadratic trends or non-linear trends via spline may be considered in the modeling. Interactions will be evaluated as well.
• Long term outcomes [ Time Frame: At 24 months ]
  Will evaluate long term outcomes at 24 months after diagnosis for financial burden. Specially, linear (or generalized linear) mixed model will be fit to study the change in the mean response over time and also the effects of cancer type, stage, treatment plan and demographics, etc. on financial burden. In case the changes in the mean response over time are not linear, the quadratic trends or non-linear trends via spline may be considered in the modeling. Interactions will be evaluated as well.
• Long term outcomes [ Time Frame: At 24 months ]
  Will evaluate long term outcomes at 24 months after diagnosis for employment limitations. Specially, linear (or generalized linear) mixed model will be fit to study the change in the mean response over time. In case the changes in the mean response over time are not linear, the quadratic trends or non-linear trends via spline may be considered in the modeling. Interactions will be evaluated as well.
• Change of quality-of-life (QoL) outcome [ Time Frame: Baseline up to 12 months ]
  Will evaluate the change of QoL from baseline to 12 months and its association with predictors. Will be evaluated by Functional Assessment of Cancer Therapy-General.
• Change in level of self-reported financial burden [ Time Frame: Baseline up to 12 months ]
  Will use alternate measures of financial burden (i.e. impact of cost questions and single item from European Organization for Research and Treatment of Cancer Questionnaire 30).

Original Secondary Outcome Measures (submitted: April 24, 2018)

• Reported access and utilization of financial services [ Time Frame: Up to 12 months ]
  Will evaluate reported access and utilization of financial services (i.e. financial counselor, navigator, social workers) and its association to financial burden in the first 12 months after diagnosis of colon or rectal cancer treated with curative-intent. Will be assessed by Consumer Based Cancer Care Value Index (CCVI). For the continuous item variable, will conduct the paired t test to examine the difference if the distribution is normal. If not normally distributed, Wilcoxon signed rank test will be used. For the categorical item variable, the paired proportion test (e.g., McNemar test) will be used instead. The association between CCVI and COST measures will be evaluated using the Pearson or Spearman correlation coefficient.
• Change in level of self-reported financial burden and employment limitations [ Time Frame: Baseline up to 12 months after cancer diagnosis ]
  Will be assessed by Work Productivity and Activity Impairment Questionnaire, Work Ability Index, and Work after cancer survey. If the distributions are normal, will conduct the paired t tests to examine the differences of these variables. If not normally distributed, Wilcoxon signed rank tests will be used. The association with COST measures will be evaluated using the Pearson or Spearman correlation coefficients.
• Long term outcomes [ Time Frame: At 24 months ]
  Will evaluate long term outcomes at 24 months after diagnosis including financial burden, employment limitations and adherence to clinical follow-up guidelines. Specially, linear (or generalized linear) mixed model will be fit to study the change in the mean response over time and also the effects of cancer type, stage, treatment plan and demographics, etc. on financial burden. In case the changes in the mean response over time are not linear, the quadratic trends or non-linear trends via spline may be considered in the modeling. Interactions will be evaluated as well.
• Change of quality-of-life (QoL) outcome [ Time Frame: Baseline up to 12 months ]
  Will evaluate the change of QoL from baseline to 12 months and its association with predictors. Will be evaluated by Functional Assessment of Cancer Therapy-General.
• Change in level of self-reported financial burden [ Time Frame: Baseline up to 12 months ]
  Will use alternate measures of financial burden (i.e. impact of cost questions and single item from European Organization for Research and Treatment of Cancer Questionnaire 30).

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Financial Burden Assessment in Patients With Stage I-III Colon or Rectal Cancer Undergoing Treatment
• Official Title: Longitudinal Assessment of Financial Burden in Patients With Colon or Rectal Cancer Treated With Curative Intent
• Brief Summary: This research trial studies the financial burden in patients with stage I-III colon or rectal cancer who are undergoing treatment. Collecting data from patients about their cost and quality of life may help doctors to better understand the impact of cancer treatment on a patient?s employment and finances.

Detailed Description

PRIMARY OBJECTIVES:

I. Evaluate the change in level of self-reported financial burden from baseline (within 60 days of diagnosis) to 12 months after diagnosis of colon or rectal cancer treated with curative-intent.

SECONDARY OBJECTVIES:

I. Evaluate reported access and utilization of financial services (i.e. financial counselor, navigator, social workers) and its association to financial burden in the first 12 months after diagnosis of colon or rectal cancer treated with curative-intent.

II. Evaluate the change in level of self-reported financial burden and employment limitations from baseline (within 60 days of diagnosis) to 3, 6, and 12 months after diagnosis of colon or rectal cancer treated with curative-intent.

III. Evaluate long term outcomes at 24 months after diagnosis including financial burden, employment limitations and adherence to clinical follow-up guidelines.

IV. Evaluate the change of quality-of-life outcome (QoL) from baseline to 12 months and its association with predictors.

V. Evaluate the change in level of self-reported financial burden from baseline to 12 months using alternate measures of financial burden (i.e. impact of cost questions and single item from European Organization for Research and Treatment of Cancer [EORTC] questionnaire [Q]30).

OUTLINE:

Patients complete questionnaires over 20-60 minutes at baseline and at 3, 6, 12, and 24 months after cancer diagnosis.

• 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 from a gastroenterology, surgical oncology, radiation oncology, or medical oncology clinic with newly diagnosed colon or rectal cancer are potential candidates for the study. Subjects must enroll within 60 days of their diagnostic biopsy or curative-intent surgery and prior to any chemotherapy and/or radiation

Condition

• Stage I Colon Cancer AJCC v8
• Stage I Rectal Cancer AJCC v8
• Stage II Colon Cancer AJCC v8
• Stage II Rectal Cancer AJCC v8
• Stage IIA Colon Cancer AJCC v8
• Stage IIA Rectal Cancer AJCC v8
• Stage IIB Colon Cancer AJCC v8
• Stage IIB Rectal Cancer AJCC v8
• Stage IIC Colon Cancer AJCC v8
• Stage IIC Rectal Cancer AJCC v8
• Stage III Colon Cancer AJCC v8
• Stage III Rectal Cancer AJCC v8
• Stage IIIA Colon Cancer AJCC v8
• Stage IIIA Rectal Cancer AJCC v8
• Stage IIIB Colon Cancer AJCC v8
• Stage IIIB Rectal Cancer AJCC v8
• Stage IIIC Colon Cancer AJCC v8
• Stage IIIC Rectal Cancer AJCC v8

Intervention

• Other: Quality-of-Life Assessment
  Ancillary studies
  Other Name: Quality of Life Assessment
• Other: Questionnaire Administration
  Ancillary studies

Study Groups/Cohorts

Observational (questionnaire)

Patients complete questionnaires over 20-60 minutes at baseline and at 3, 6, 12, and 24 months after cancer diagnosis.

Interventions:

• Other: Quality-of-Life Assessment
• Other: Questionnaire Administration

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: April 24, 2018): 563
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 1, 2028
• Estimated Primary Completion Date: September 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients must have a life expectancy of >= 24 months
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3
• Patients must have a newly diagnosed colon or rectal cancer (initial diagnosis, either a biopsy or curative surgery, whichever is most recent) within 60 days of registration and have not yet received radiation or chemotherapy
• Patients must have stage I, II, or III disease at the time of enrollment and will be treated with curative-intent; this can be defined either clinically or pathologically if they have already undergone surgery; for staging of both colon and rectal cancer, the definition of stage I-III is based on the seventh edition (2010) or an updated version of the tumor, node, metastasis (TNM) staging system
• Patients are not eligible if they are already enrolled on a treatment clinical trial at the time of registration; they can remain on the study if they subsequently enroll on a treatment clinical trial during the study time period
• Patients who choose to not receive radiation and/or chemotherapy after a curative-intent surgery are eligible to participate
• Patients with a history of previous malignancy (except non-melanoma skin or cervical in-situ cancer) treated (with either surgery, chemotherapy, and/or radiation) within the last 3 years are not eligible
• Patients must be able to complete questionnaires in English
• Patients must sign and give written informed consent in accordance with institutional and federal guidelines

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

Administrative Information

• NCT Number: NCT03516942
• Other Study ID Numbers: EAQ162CD; NCI-2018-00151 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); EAQ162CD ( Other Identifier: ECOG-ACRIN Cancer Research Group ); ECOG-ACRIN-EAQ162CD ( Other Identifier: DCP ); ECOG-ACRIN-EAQ162CD ( Other Identifier: CTEP )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
• Study Sponsor: ECOG-ACRIN Cancer Research Group
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Sheetal Kircher; ECOG-ACRIN Cancer Research Group

• PRS Account: Eastern Cooperative Oncology Group
• Verification Date: October 2020