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.
Brief Title
Financial Burden Assessment in Patients With Stage I-III Colon or Rectal Cancer Undergoing Treatment
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.
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
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
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03516942
Org Class
Network
Org Full Name
Eastern Cooperative Oncology Group
Org Study Id
EAQ162CD
Overall Status
Active, not recruiting
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Longitudinal Assessment of Financial Burden in Patients With Colon or Rectal Cancer Treated With Curative Intent
Primary Outcomes
Outcome Description
The Comprehensive Score for Financial Toxicity (COST) COST is an 11-item patient-reported outcome (PRO) of financial hardship that uses a 7-day time window and 5-point Likert response scale (ranging from 0, indicating not at all, to 4, very much). Higher COST scores (range, 0-44) represent better financial well-being.
The primary objective is to evaluate the change in the level of self-reported financial burden from baseline (within 60 days of diagnosis) to 12 months from study registration. (12 mo - baseline)
The primary objective is to evaluate the change in the level of self-reported financial burden from baseline (within 60 days of diagnosis) to 12 months from study registration. (12 mo - baseline)
Outcome Measure
Comprehensive Score for Financial Toxicity (COST)
Outcome Time Frame
Baseline and 12 months after cancer diagnosis
Secondary Ids
Secondary Id
NCI-2018-00151
Secondary Id
EAQ162CD
Secondary Id
ECOG-ACRIN-EAQ162CD
Secondary Id
ECOG-ACRIN-EAQ162CD
Secondary Id
U10CA180820
Secondary Id
UG1CA189828
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Up to 12 months
Outcome Measure
Reported Access and Utilization of Financial Services
Outcome Description
Change in level of self-reported employment limitations from baseline to 6, 12 and 24 months after study registration will be assessed by Work Productivity and Activity Impairment Questionnaire for a Specific Health Problem (WPAI:SHP). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, as follows:
Questions:
1. = currently employed
2. = hours missed due to specified problem
3. = hours missed other reasons
4. = hours actually worked
5. = degree problem affected productivity while working
6. = degree problem affected regular activities
Scores:
Multiply scores by 100 to express in percentages.
Percent work time missed due to problem: Q2/(Q2+Q4)
Percent impairment while working due to problem: Q5/10
Percent overall work impairment due to problem:
Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4)))x(Q5/10)\]
Percent activity impairment due to problem: Q6/10
Questions:
1. = currently employed
2. = hours missed due to specified problem
3. = hours missed other reasons
4. = hours actually worked
5. = degree problem affected productivity while working
6. = degree problem affected regular activities
Scores:
Multiply scores by 100 to express in percentages.
Percent work time missed due to problem: Q2/(Q2+Q4)
Percent impairment while working due to problem: Q5/10
Percent overall work impairment due to problem:
Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4)))x(Q5/10)\]
Percent activity impairment due to problem: Q6/10
Outcome Time Frame
Baseline, 6, 12, and 24 months after cancer diagnosis
Outcome Measure
Change in Level of Self-reported Employment Limitations
Outcome Description
Change in level of self-reported employment limitations from baseline to 6, 12 and 24 months after study registration will be assessed by Work Productivity and Activity Impairment Questionnaire for a Specific Health Problem (WPAI:SHP). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. These outcomes were further dichotomized at 50%, such that Impairment \> 50% was considered impaired and Impairment \<=50% was not-impaired
Outcome Time Frame
Baseline, 6, 12, and 24 months after cancer diagnosis
Outcome Measure
Level of Self-reported Employment Limitations (Dichotomized)
Outcome Description
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.
Outcome Time Frame
At 24 months
Outcome Measure
Long Term Outcomes After Diagnosis for Adherence
Outcome Description
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.
Outcome Time Frame
At 24 months
Outcome Measure
Long Term Outcomes After Diagnosis for Financial Burden
Outcome Description
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.
Outcome Time Frame
At 24 months
Outcome Measure
Long Term Outcomes After Diagnosis for Employment Limitations
Outcome Description
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.
Outcome Time Frame
Baseline up to 12 months
Outcome Measure
Change of Quality-of-life (QoL) Outcome
Outcome Description
Financial Burden was evaluated using a single item from European Organization for Research and Treatment of Cancer Questionnaire 30 \[EORT30\]) with responses for both baseline and 12 months
EORTC30 question:
Has your physical condition or medical treatment caused you financial difficulties?
* Not at all
* A little
* Quite a bit
* Very much with higher values indicating greater financial difficulty (burden) Responses were dichotomized into No difficulty ("Not at All" ) and some difficulty ( "A little", "Quite a bit", or "Very much")
EORTC30 question:
Has your physical condition or medical treatment caused you financial difficulties?
* Not at all
* A little
* Quite a bit
* Very much with higher values indicating greater financial difficulty (burden) Responses were dichotomized into No difficulty ("Not at All" ) and some difficulty ( "A little", "Quite a bit", or "Very much")
Outcome Time Frame
Baseline and12 months
Outcome Measure
Changes Self-reported Financial Burden Between Baseline and 12 Month [EORTC]
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
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
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jonathan Klein
Investigator Email
joklein@montefiore.org
Investigator Phone