Stage I Colon 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 II Colon Cancer AJCC v8, Stage IIC 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 III Colon Cancer AJCC v8, Stage IIIC Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8, Stage II Rectal Cancer AJCC v8, Stage I Rectal Cancer AJCC v8
Conditions
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.
Interventions
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comprehensive Score for Financial Toxicity (COST) | Baseline and 12 months after cancer diagnosis | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reported Access and Utilization of Financial Services | 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 Employment Limitations | Baseline, 6, 12, and 24 months after cancer diagnosis | 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 |
| Level of Self-reported Employment Limitations (Dichotomized) | Baseline, 6, 12, and 24 months after cancer diagnosis | 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 |
| Long Term Outcomes After Diagnosis for Adherence | 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 After Diagnosis for Financial Burden | 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 After Diagnosis for Employment Limitations | 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 | 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. |
| Changes Self-reported Financial Burden Between Baseline and 12 Month [EORTC] | Baseline and12 months | 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") |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSheetal Kircher
ECOG-ACRIN Cancer Research Group
Participant flow
Recruitment details
This was a, longitudinal cohort study of financial burden in patients with colon, rectal, or rectosigmoid junction cancer. Measurements of financial burden (COST score) were collected at 5 time points over a 24-month follow-up period. Surveys were completed both by sites, to identify available clinical resources, and by participants, to assess the QoL and cost. The primary endpoint of this study was the change of the COST score from the baseline measurement to the 12-month follow-up (FU).
Participants by arm
| Arm | Count |
|---|---|
| Observational (Questionnaire) Patients complete questionnaires to assess financial burden | 450 |
| Total | 450 |
Baseline characteristics
| Characteristic | Observational (Questionnaire) |
|---|---|
| Age, Continuous | 61.0 years STANDARD_DEVIATION 12 |
| Cancer Stage at Enrollment Stage III | 242 Participants |
| Cancer Stage at Enrollment Stage l | 68 Participants |
| Cancer Stage at Enrollment Stage lI | 140 Participants |
| Cancer Type Colon Cancer | 289 Participants |
| Cancer Type Rectal Cancer | 140 Participants |
| Cancer Type Rectosigmoid Junction | 21 Participants |
| Chemotherapy No Chemtherapy | 183 Participants |
| Chemotherapy Schedule Chemotherapy | 267 Participants |
| Employment Employed | 214 Participants |
| Employment Not Answered | 6 Participants |
| Employment Retired | 153 Participants |
| Employment Unemployed | 77 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 424 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants |
| Race (NIH/OMB) Asian | 21 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 379 Participants |
| Sex: Female, Male Female | 210 Participants |
| Sex: Female, Male Male | 240 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 13 / 57 | 0 / 455 | 5 / 301 | 5 / 272 | 4 / 233 | 2 / 245 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 13 / 57 | 0 / 455 | 4 / 301 | 4 / 272 | 12 / 233 | 2 / 245 |
Outcome results
Primary
Comprehensive Score for Financial Toxicity (COST)
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)
Time frame: Baseline and 12 months after cancer diagnosis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T0: Observational (Questionnaire) | Comprehensive Score for Financial Toxicity (COST) | 23.5 score on a scale | Standard Deviation 11.9 |
| T2:Observational (Questionnaire) | Comprehensive Score for Financial Toxicity (COST) | 28.6 score on a scale | Standard Deviation 11.7 |
Comparison: Age covariate effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equalp-value: 0.7495% CI: [-0.1, 0.2]Regression, Linear
Comparison: Baseline COST effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equalp-value: <0.00195% CI: [-0.6, -0.3]Regression, Linear
Comparison: Cancer type (Colon cancer, Rectal cancer and Rectosigmoid) effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equalp-value: 0.002Regression, Linear
Comparison: FACT-G7 effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equalp-value: 0.0395% CI: [0, 0.6]Regression, Linear
Comparison: Gender effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equalp-value: 0.1395% CI: [-0.5, 3.7]Regression, Linear
Comparison: RACE (White. Black Other) effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equalp-value: 0.91Regression, Linear
Comparison: Neighborhood Deprivation (NDI) effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Higher NDI = greater neighborhood deprivationp-value: >0.9995% CI: [-0.3, 0.3]Regression, Linear
Secondary
Change in Level of Self-reported Employment Limitations
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
Time frame: Baseline, 6, 12, and 24 months after cancer diagnosis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| T0: Observational (Questionnaire) | Change in Level of Self-reported Employment Limitations | Work Time Missed | 39.7 percentage of activity impaired | Standard Deviation 39.3 |
| T0: Observational (Questionnaire) | Change in Level of Self-reported Employment Limitations | Impairment of Activities at Work | 20.8 percentage of activity impaired | Standard Deviation 33.4 |
| T0: Observational (Questionnaire) | Change in Level of Self-reported Employment Limitations | Overall Work Impairment | 51.8 percentage of activity impaired | Standard Deviation 37.5 |
| T0: Observational (Questionnaire) | Change in Level of Self-reported Employment Limitations | Impairment of Activities Outside of Work | 33.2 percentage of activity impaired | Standard Deviation 31.8 |
| T2:Observational (Questionnaire) | Change in Level of Self-reported Employment Limitations | Impairment of Activities at Work | 28.1 percentage of activity impaired | Standard Deviation 33 |
| T2:Observational (Questionnaire) | Change in Level of Self-reported Employment Limitations | Overall Work Impairment | 36.6 percentage of activity impaired | Standard Deviation 36.6 |
| T2:Observational (Questionnaire) | Change in Level of Self-reported Employment Limitations | Impairment of Activities Outside of Work | 31.3 percentage of activity impaired | Standard Deviation 31.9 |
| T2:Observational (Questionnaire) | Change in Level of Self-reported Employment Limitations | Work Time Missed | 18.2 percentage of activity impaired | Standard Deviation 30.7 |
| 12-month Questionnaire | Change in Level of Self-reported Employment Limitations | Overall Work Impairment | 17.8 percentage of activity impaired | Standard Deviation 28 |
| 12-month Questionnaire | Change in Level of Self-reported Employment Limitations | Impairment of Activities at Work | 14.0 percentage of activity impaired | Standard Deviation 24.6 |
| 12-month Questionnaire | Change in Level of Self-reported Employment Limitations | Impairment of Activities Outside of Work | 17.0 percentage of activity impaired | Standard Deviation 25.8 |
| 12-month Questionnaire | Change in Level of Self-reported Employment Limitations | Work Time Missed | 4.8 percentage of activity impaired | Standard Deviation 16.1 |
| 24-month Questionnaire | Change in Level of Self-reported Employment Limitations | Impairment of Activities Outside of Work | 15.8 percentage of activity impaired | Standard Deviation 24.2 |
| 24-month Questionnaire | Change in Level of Self-reported Employment Limitations | Impairment of Activities at Work | 14.4 percentage of activity impaired | Standard Deviation 22.3 |
| 24-month Questionnaire | Change in Level of Self-reported Employment Limitations | Work Time Missed | 6.1 percentage of activity impaired | Standard Deviation 18 |
| 24-month Questionnaire | Change in Level of Self-reported Employment Limitations | Overall Work Impairment | 19.1 percentage of activity impaired | Standard Deviation 26.8 |
Comparison: Work Time Missed from Baseline to 24 Monthsp-value: 0.0027McNemar
Comparison: Work Time Missed from Baseline to 6 Monthsp-value: 0.4142McNemar
Comparison: Impairment of Activities at Work from Baseline to 6 Monthsp-value: 0.1797McNemar
Comparison: Overall Work Impairment from Baseline to 6 Monthsp-value: 0.8415McNemar
Comparison: Impairment of Activities Outside of Work from Baseline to 6 Monthsp-value: 0.6831McNemar
Comparison: Work Time Missed from Baseline to 12 Monthsp-value: <0.0001McNemar
Comparison: Impairment of Activities at Work from Baseline to 12 Monthsp-value: 0.0455McNemar
Comparison: Overall Work Impairment from Baseline to 12 Monthsp-value: <0.0001McNemar
Comparison: 3 Impairment of Activities Outside of Work from Baseline to 12 Monthsp-value: 0.0164McNemar
Comparison: Impairment of Activities at Work from Baseline to 24 Monthsp-value: 0.0124McNemar
Comparison: Overall Work Impairment from Baseline to 24 Monthsp-value: <0.0001McNemar
Comparison: Impairment of Activities Outside of Work from Baseline to 24 Monthsp-value: 0.0011McNemar
Secondary
Change of Quality-of-life (QoL) Outcome
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.
Time frame: Baseline up to 12 months
Secondary
Changes Self-reported Financial Burden Between Baseline and 12 Month [EORTC]
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)
Time frame: Baseline and12 months
Population: participants who completed both the baseline and 12 month EORTC questionnaire
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| T0: Observational (Questionnaire) | Changes Self-reported Financial Burden Between Baseline and 12 Month [EORTC] | No difficulty (Not at All ) at 12 months | 74 Participants |
| T0: Observational (Questionnaire) | Changes Self-reported Financial Burden Between Baseline and 12 Month [EORTC] | Some Difficulty ( A little, Quite a bit, or Very much) at 12 Months | 17 Participants |
| T2:Observational (Questionnaire) | Changes Self-reported Financial Burden Between Baseline and 12 Month [EORTC] | No difficulty (Not at All ) at 12 months | 34 Participants |
| T2:Observational (Questionnaire) | Changes Self-reported Financial Burden Between Baseline and 12 Month [EORTC] | Some Difficulty ( A little, Quite a bit, or Very much) at 12 Months | 80 Participants |
Comparison: the McNemar test was used to compare the results assuming a null of no difference.p-value: 0.017McNemar
Secondary
Level of Self-reported Employment Limitations (Dichotomized)
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
Time frame: Baseline, 6, 12, and 24 months after cancer diagnosis
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| T0: Observational (Questionnaire) | Level of Self-reported Employment Limitations (Dichotomized) | Work Time Missed | Impaired ( score >50%) | 124 Participants |
| T0: Observational (Questionnaire) | Level of Self-reported Employment Limitations (Dichotomized) | Work Time Missed | Impaired ( score <=50%) | 68 Participants |
| T0: Observational (Questionnaire) | Level of Self-reported Employment Limitations (Dichotomized) | Impairment of Activities at Work | Impaired ( score >50%) | 139 Participants |
| T0: Observational (Questionnaire) | Level of Self-reported Employment Limitations (Dichotomized) | Impairment of Activities at Work | Impaired ( score <=50%) | 53 Participants |
| T0: Observational (Questionnaire) | Level of Self-reported Employment Limitations (Dichotomized) | Overall Work Impairment | Impaired ( score >50%) | 93 Participants |
| T0: Observational (Questionnaire) | Level of Self-reported Employment Limitations (Dichotomized) | Overall Work Impairment | Impaired ( score <=50%) | 99 Participants |
| T0: Observational (Questionnaire) | Level of Self-reported Employment Limitations (Dichotomized) | Impairment of Activities Outside of Work | Impaired ( score >50%) | 121 Participants |
| T0: Observational (Questionnaire) | Level of Self-reported Employment Limitations (Dichotomized) | Impairment of Activities Outside of Work | Impaired ( score <=50%) | 71 Participants |
| T2:Observational (Questionnaire) | Level of Self-reported Employment Limitations (Dichotomized) | Overall Work Impairment | Impaired ( score <=50%) | 29 Participants |
| T2:Observational (Questionnaire) | Level of Self-reported Employment Limitations (Dichotomized) | Overall Work Impairment | Impaired ( score >50%) | 40 Participants |
| T2:Observational (Questionnaire) | Level of Self-reported Employment Limitations (Dichotomized) | Work Time Missed | Impaired ( score <=50%) | 14 Participants |
| T2:Observational (Questionnaire) | Level of Self-reported Employment Limitations (Dichotomized) | Impairment of Activities Outside of Work | Impaired ( score <=50%) | 22 Participants |
| T2:Observational (Questionnaire) | Level of Self-reported Employment Limitations (Dichotomized) | Impairment of Activities Outside of Work | Impaired ( score >50%) | 47 Participants |
| T2:Observational (Questionnaire) | Level of Self-reported Employment Limitations (Dichotomized) | Impairment of Activities at Work | Impaired ( score <=50%) | 22 Participants |
| T2:Observational (Questionnaire) | Level of Self-reported Employment Limitations (Dichotomized) | Impairment of Activities at Work | Impaired ( score >50%) | 47 Participants |
| T2:Observational (Questionnaire) | Level of Self-reported Employment Limitations (Dichotomized) | Work Time Missed | Impaired ( score >50%) | 55 Participants |
| 12-month Questionnaire | Level of Self-reported Employment Limitations (Dichotomized) | Impairment of Activities Outside of Work | Impaired ( score >50%) | 49 Participants |
| 12-month Questionnaire | Level of Self-reported Employment Limitations (Dichotomized) | Impairment of Activities at Work | Impaired ( score >50%) | 51 Participants |
| 12-month Questionnaire | Level of Self-reported Employment Limitations (Dichotomized) | Impairment of Activities at Work | Impaired ( score <=50%) | 9 Participants |
| 12-month Questionnaire | Level of Self-reported Employment Limitations (Dichotomized) | Overall Work Impairment | Impaired ( score >50%) | 49 Participants |
| 12-month Questionnaire | Level of Self-reported Employment Limitations (Dichotomized) | Overall Work Impairment | Impaired ( score <=50%) | 11 Participants |
| 12-month Questionnaire | Level of Self-reported Employment Limitations (Dichotomized) | Impairment of Activities Outside of Work | Impaired ( score <=50%) | 11 Participants |
| 12-month Questionnaire | Level of Self-reported Employment Limitations (Dichotomized) | Work Time Missed | Impaired ( score >50%) | 58 Participants |
| 12-month Questionnaire | Level of Self-reported Employment Limitations (Dichotomized) | Work Time Missed | Impaired ( score <=50%) | 2 Participants |
| 24-month Questionnaire | Level of Self-reported Employment Limitations (Dichotomized) | Impairment of Activities at Work | Impaired ( score >50%) | 49 Participants |
| 24-month Questionnaire | Level of Self-reported Employment Limitations (Dichotomized) | Impairment of Activities at Work | Impaired ( score <=50%) | 8 Participants |
| 24-month Questionnaire | Level of Self-reported Employment Limitations (Dichotomized) | Work Time Missed | Impaired ( score <=50%) | 3 Participants |
| 24-month Questionnaire | Level of Self-reported Employment Limitations (Dichotomized) | Work Time Missed | Impaired ( score >50%) | 54 Participants |
| 24-month Questionnaire | Level of Self-reported Employment Limitations (Dichotomized) | Overall Work Impairment | Impaired ( score >50%) | 47 Participants |
| 24-month Questionnaire | Level of Self-reported Employment Limitations (Dichotomized) | Impairment of Activities Outside of Work | Impaired ( score <=50%) | 9 Participants |
| 24-month Questionnaire | Level of Self-reported Employment Limitations (Dichotomized) | Impairment of Activities Outside of Work | Impaired ( score >50%) | 48 Participants |
| 24-month Questionnaire | Level of Self-reported Employment Limitations (Dichotomized) | Overall Work Impairment | Impaired ( score <=50%) | 10 Participants |
Secondary
Long Term Outcomes After Diagnosis for Adherence
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.
Time frame: At 24 months
Secondary
Long Term Outcomes After Diagnosis for Employment Limitations
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.
Time frame: At 24 months
Secondary
Long Term Outcomes After Diagnosis for Financial Burden
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.
Time frame: At 24 months
Secondary
Reported Access and Utilization of Financial Services
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.
Time frame: Up to 12 months