ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    EAQ162CD
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03516942
Recruitment Status : Recruiting
First Posted : May 7, 2018
Last Update Posted : June 14, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

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.

Condition or disease Intervention/treatment
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 Other: Quality-of-Life Assessment Other: Questionnaire Administration

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
Estimated Enrollment : 563 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Assessment of Financial Burden in Patients With Colon or Rectal Cancer Treated With Curative Intent
Actual Study Start Date : May 17, 2018
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 1, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Group/Cohort Intervention/treatment
Observational (questionnaire)
Patients complete questionnaires over 20-60 minutes at baseline and at 3, 6, 12, and 24 months after cancer diagnosis.
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516942


Locations
United States, Pennsylvania
ECOG-ACRIN Cancer Research Group Recruiting
Philadelphia, Pennsylvania, United States, 19103
Contact: Sheetal Kircher, MD    312-695-6180    skirche1@nm.org   
Principal Investigator: Sheetal Kircher, MD         
Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Sheetal Kircher ECOG-ACRIN Cancer Research Group

Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT03516942     History of Changes
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 )
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Rectal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases