Trial Outcomes & Findings for S1417CD Financial Impact Assessment Tool in Patients With Metastatic Colorectal Cancer (NCT NCT02728804)
NCT ID: NCT02728804
Last Updated: 2023-01-26
Results Overview
The cumulative incidence estimates of participants experiencing both major financial hardship (MFH) and multiple financial hardships will be reported. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. A major financial hardship is 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.
COMPLETED
380 participants
Up to 12 months
2023-01-26
Participant Flow
380 patients were enrolled between June 2016 and January 2019.
Participant milestones
| Measure |
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.
Quality-of-Life Assessment: Complete questionnaire
Questionnaire Administration: Complete questionnaires
|
|---|---|
|
Overall Study
STARTED
|
380
|
|
Overall Study
Eligible and Completed Baseline Questionnaire
|
368
|
|
Overall Study
COMPLETED
|
269
|
|
Overall Study
NOT COMPLETED
|
111
|
Reasons for withdrawal
| Measure |
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.
Quality-of-Life Assessment: Complete questionnaire
Questionnaire Administration: Complete questionnaires
|
|---|---|
|
Overall Study
Ineligible
|
3
|
|
Overall Study
Did not complete baseline questionnaire
|
9
|
|
Overall Study
Death
|
99
|
Baseline Characteristics
S1417CD Financial Impact Assessment Tool in Patients With Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Health Services Research (Questionnaire Administration)
n=368 Participants
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.
Quality-of-Life Assessment: Complete questionnaire
Questionnaire Administration: Complete questionnaires
|
|---|---|
|
Prediagnosis Employment Status
Employed (full-time, part-time, self-employed)
|
222 Participants
n=5 Participants
|
|
Prediagnosis Employment Status
Retired
|
93 Participants
n=5 Participants
|
|
Total Assets
$250,001-$500,000
|
29 Participants
n=5 Participants
|
|
Prediagnosis Employment Status
On leave of absence from paid employment
|
2 Participants
n=5 Participants
|
|
Prediagnosis Employment Status
Unemployed
|
13 Participants
n=5 Participants
|
|
Prediagnosis Employment Status
Temporary or permanent disability
|
25 Participants
n=5 Participants
|
|
Prediagnosis Employment Status
Other or unknown
|
13 Participants
n=5 Participants
|
|
Total Assets
$0-$25,000
|
202 Participants
n=5 Participants
|
|
Total Assets
$25,001-$50,000
|
25 Participants
n=5 Participants
|
|
Total Assets
$50,001-$100,000
|
38 Participants
n=5 Participants
|
|
Total Assets
$100,001-$250,000
|
32 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
231 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
137 Participants
n=5 Participants
|
|
Age, Continuous
|
60.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
228 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
286 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other or Unknown
|
17 Participants
n=5 Participants
|
|
Homeowner
Yes
|
236 Participants
n=5 Participants
|
|
Homeowner
No
|
124 Participants
n=5 Participants
|
|
Homeowner
Unknown
|
8 Participants
n=5 Participants
|
|
Marital Status
Married/Partnered
|
213 Participants
n=5 Participants
|
|
Marital Status
Divorced or separated
|
82 Participants
n=5 Participants
|
|
Marital Status
Widowed
|
17 Participants
n=5 Participants
|
|
Marital Status
Never married
|
48 Participants
n=5 Participants
|
|
Marital Status
Unknown
|
8 Participants
n=5 Participants
|
|
Primary Insurance
Private insurance (employer provided)
|
171 Participants
n=5 Participants
|
|
Primary Insurance
Medicare
|
143 Participants
n=5 Participants
|
|
Total Assets
$500,001 or more
|
34 Participants
n=5 Participants
|
|
Total Assets
Unknown
|
8 Participants
n=5 Participants
|
|
Primary Insurance
Medicaid
|
44 Participants
n=5 Participants
|
|
Primary Insurance
Other
|
3 Participants
n=5 Participants
|
|
Primary Insurance
Uninsured
|
7 Participants
n=5 Participants
|
|
Total Household Income
$0-$25,000
|
114 Participants
n=5 Participants
|
|
Total Household Income
$25,001-$50,000
|
94 Participants
n=5 Participants
|
|
Total Household Income
$50,001-$75,000
|
54 Participants
n=5 Participants
|
|
Total Household Income
$75,001-$100,000
|
31 Participants
n=5 Participants
|
|
Total Household Income
$100,001 or more
|
65 Participants
n=5 Participants
|
|
Total Household Income
Unknown
|
10 Participants
n=5 Participants
|
|
Education
High school graduate or less
|
143 Participants
n=5 Participants
|
|
Education
Vocational school or some college
|
111 Participants
n=5 Participants
|
|
Education
Bachelor degree
|
63 Participants
n=5 Participants
|
|
Education
Master, doctorate, or professional degree
|
43 Participants
n=5 Participants
|
|
Education
Missing
|
8 Participants
n=5 Participants
|
|
Prior Diagnosis of Stage I-III Colorectal Cancer
Yes
|
93 Participants
n=5 Participants
|
|
Prior Diagnosis of Stage I-III Colorectal Cancer
No, de novo diagnosis of stage IV
|
275 Participants
n=5 Participants
|
|
ECOG Performance Score
0
|
183 Participants
n=5 Participants
|
|
ECOG Performance Score
1
|
158 Participants
n=5 Participants
|
|
ECOG Performance Score
2
|
22 Participants
n=5 Participants
|
|
ECOG Performance Score
3
|
4 Participants
n=5 Participants
|
|
ECOG Performance Score
Unknown
|
1 Participants
n=5 Participants
|
|
Initial Treatment Regimen
(5-FU or cap) ± bevacizumab
|
38 Participants
n=5 Participants
|
|
Initial Treatment Regimen
(FOLFOX or CapOX) ± bevacizumab
|
228 Participants
n=5 Participants
|
|
Initial Treatment Regimen
(FOLFIRI or CapIRI) ± bevacizumab
|
55 Participants
n=5 Participants
|
|
Initial Treatment Regimen
(FOLFOX, CapOX, FOLFIRI, or CapIRI) + EGFR inhibitor
|
15 Participants
n=5 Participants
|
|
Initial Treatment Regimen
Other
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: The analysis population includes only the 302 participants that were evaluable for the primary endpoint - either completed 12-month evaluation or met primary endpoint.
The cumulative incidence estimates of participants experiencing both major financial hardship (MFH) and multiple financial hardships will be reported. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. A major financial hardship is 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.
Outcome measures
| Measure |
Health Services Research (Questionnaire Administration)
n=302 Participants
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.
Quality-of-Life Assessment: Complete questionnaire
Questionnaire Administration: Complete questionnaires
|
>=65 Years
This group is comprised of eligible and evaluable participants that are under 65 years of age.
|
<$100,000
This group is comprised of eligible and evaluable participants whose yearly income is less than $100,000.
|
>=$100,000
This group is comprised of eligible and evaluable participants whose yearly income is at least $100,000.
|
|---|---|---|---|---|
|
Cumulative Incidence Rate of Treatment-related Major Financial Hardship
Any MFH
|
71.3 percentage of participants
Interval 65.7 to 76.1
|
—
|
—
|
—
|
|
Cumulative Incidence Rate of Treatment-related Major Financial Hardship
New Debt
|
57.6 percentage of participants
Interval 51.7 to 63.0
|
—
|
—
|
—
|
|
Cumulative Incidence Rate of Treatment-related Major Financial Hardship
>=20% Income Decline
|
26.6 percentage of participants
Interval 21.3 to 32.0
|
—
|
—
|
—
|
|
Cumulative Incidence Rate of Treatment-related Major Financial Hardship
Loans from Family and/or Friends
|
26.0 percentage of participants
Interval 21.5 to 30.7
|
—
|
—
|
—
|
|
Cumulative Incidence Rate of Treatment-related Major Financial Hardship
Refinance of Home
|
3.4 percentage of participants
Interval 1.7 to 5.9
|
—
|
—
|
—
|
|
Cumulative Incidence Rate of Treatment-related Major Financial Hardship
Sale of Home
|
2.6 percentage of participants
Interval 1.3 to 4.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: There were a total of 302 participants analyzed which either completed the 12-month evaluation or met the primary endpoint.
The cumulative incidence estimates of participants experiencing MFH within age groups. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. This is used to assess whether major financial hardship at one year differs by age (\< 65 vs. \>= 65). Age is taken at baseline.
Outcome measures
| Measure |
Health Services Research (Questionnaire Administration)
n=192 Participants
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.
Quality-of-Life Assessment: Complete questionnaire
Questionnaire Administration: Complete questionnaires
|
>=65 Years
n=110 Participants
This group is comprised of eligible and evaluable participants that are under 65 years of age.
|
<$100,000
This group is comprised of eligible and evaluable participants whose yearly income is less than $100,000.
|
>=$100,000
This group is comprised of eligible and evaluable participants whose yearly income is at least $100,000.
|
|---|---|---|---|---|
|
Association of Age and Cumulative Incidence Rate of Major Financial Hardship
|
73.7 percentage of participants
Interval 66.4 to 79.6
|
68.1 percentage of participants
Interval 58.6 to 76.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 292 total participants were analyzed which had baseline race information available and either completed the 12-month evaluation or met the primary endpoint.
The cumulative incidence estimates of participants experiencing MFH within racial groups. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. This is used to assess whether major financial hardship at one year differs by race (white vs. non-white).
Outcome measures
| Measure |
Health Services Research (Questionnaire Administration)
n=240 Participants
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.
Quality-of-Life Assessment: Complete questionnaire
Questionnaire Administration: Complete questionnaires
|
>=65 Years
n=52 Participants
This group is comprised of eligible and evaluable participants that are under 65 years of age.
|
<$100,000
This group is comprised of eligible and evaluable participants whose yearly income is less than $100,000.
|
>=$100,000
This group is comprised of eligible and evaluable participants whose yearly income is at least $100,000.
|
|---|---|---|---|---|
|
Association of Race and Cumulative Incidence Rate of Major Financial Hardship
|
70.3 percentage of participants
Interval 64.1 to 75.6
|
73.9 percentage of participants
Interval 59.4 to 83.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 295 participants were analyzed who had baseline marital status information available and either completed the 12-month evaluation or met the primary endpoint.
The cumulative percentage of participants experiencing MFH within marital status groups. This is used to assess whether major financial hardship at one year differs by age (married vs. unmarried). Marital status is taken at baseline.
Outcome measures
| Measure |
Health Services Research (Questionnaire Administration)
n=116 Participants
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.
Quality-of-Life Assessment: Complete questionnaire
Questionnaire Administration: Complete questionnaires
|
>=65 Years
n=179 Participants
This group is comprised of eligible and evaluable participants that are under 65 years of age.
|
<$100,000
This group is comprised of eligible and evaluable participants whose yearly income is less than $100,000.
|
>=$100,000
This group is comprised of eligible and evaluable participants whose yearly income is at least $100,000.
|
|---|---|---|---|---|
|
Association of Marital Status and Cumulative Incidence Rate of Major Financial Hardship
|
69.0 percentage of participants
Interval 60.5 to 76.1
|
72.2 percentage of participants
Interval 64.0 to 78.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 295 participants were analyzed that had baseline employment status information available and either completed the 12-month evaluation or met the primary endpoint.
The cumulative incidence estimates of participants experiencing MFH within different employment status groups. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. This is used to assess whether major financial hardship at one year differs by pre-diagnosis employment status (any employment vs. unemployed). Employment status is taken at baseline.
Outcome measures
| Measure |
Health Services Research (Questionnaire Administration)
n=101 Participants
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.
Quality-of-Life Assessment: Complete questionnaire
Questionnaire Administration: Complete questionnaires
|
>=65 Years
n=194 Participants
This group is comprised of eligible and evaluable participants that are under 65 years of age.
|
<$100,000
This group is comprised of eligible and evaluable participants whose yearly income is less than $100,000.
|
>=$100,000
This group is comprised of eligible and evaluable participants whose yearly income is at least $100,000.
|
|---|---|---|---|---|
|
Association of Employment Status and Cumulative Incidence Rate of Major Financial Hardship
|
62.9 percentage of participants
Interval 53.8 to 70.7
|
76.2 percentage of participants
Interval 69.2 to 81.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 294 total participants were analyzed which had baseline household income information available and either completed the 12-month evaluation or met the primary endpoint. The number of participants in the \<$50,000 arm and \>=$50,000 arm equal the total (294) participants analyzed. Similarly, the number of participants in the \<$100,000 arm and \>=$100,000 arm equal the total (294) participants analyzed.
The cumulative incidence estimates of participants experiencing MFH within income groups. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. This is used to assess whether major financial hardship at one year differs by household income (\<$50,000 vs. \>=$50,000 and \<$100,000 vs. \>=$100,000). Household income is taken at baseline.
Outcome measures
| Measure |
Health Services Research (Questionnaire Administration)
n=168 Participants
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.
Quality-of-Life Assessment: Complete questionnaire
Questionnaire Administration: Complete questionnaires
|
>=65 Years
n=126 Participants
This group is comprised of eligible and evaluable participants that are under 65 years of age.
|
<$100,000
n=239 Participants
This group is comprised of eligible and evaluable participants whose yearly income is less than $100,000.
|
>=$100,000
n=55 Participants
This group is comprised of eligible and evaluable participants whose yearly income is at least $100,000.
|
|---|---|---|---|---|
|
Association of Income and Cumulative Incidence Rate of Major Financial Hardship
|
72.7 percentage of participants
Interval 65.6 to 78.6
|
69.1 percentage of participants
Interval 59.3 to 77.1
|
72.9 percentage of participants
Interval 67.0 to 77.9
|
64.9 percentage of participants
Interval 45.6 to 78.8
|
SECONDARY outcome
Timeframe: Up to 12 monthsThe 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to up to 12 monthsWill 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsWill 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to up to 12 monthsWill 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsThe 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsEach 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsCredit 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsThe 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsWill 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.
Outcome measures
Outcome data not reported
Adverse Events
Health Services Research (Questionnaire Administration)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Cancer Care Delivery Committee Statistician
SWOG Statistics and Data Management Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60