![Page 1: Jonas&de&Souza,&MD,&MBA Assistant&Professor&&& · 2018-09-24 · Costs to the payer •!Ihave!no!conflicts!of!interestto!disclose!! Presented!by:!Jonas!de!Souza,!MD! MEDICARE 2004](https://reader033.vdocument.in/reader033/viewer/2022042416/5f30dd0fc28df65229123564/html5/thumbnails/1.jpg)
Jonas de Souza, MD, MBA Assistant Professor
The University of Chicago
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• I have no conflicts of interests
Disclosures
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• I have no conflicts of interests today – Moving to Humana in July 2017 – I will have conflicts of interests
Disclosures
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• Describe how we developed and validated the COmprehensive Score for financial Toxicity PRO
• Illustrate applicaIons of the COST-‐PRO in pracIce
• Discuss potenIal future direcIons
Financial Toxicity
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Costs to the payer
• I have no conflicts of interest to disclose
Presented by: Jonas de Souza, MD
MEDICARE 2004 PPPY: $37799
MEDICARE 2014 PPPY: $51566
COMMERCIAL 2004 PPPY: $55789
COMMERCIAL 2014 PPPY: $90656
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Costs to the payer
• I have no conflicts of interest to disclose
Presented by: Jonas de Souza, MD
MEDICARE 2004
MEDICARE 2014
COMMERCIAL 2004
COMMERCIAL 2014
62%
36%
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Cost-sharing is increasing
Presented by: Jonas de Souza, MD
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VISIBLE TO THE PATIENTS
Patients only see the tip of the iceberg
Presented by: Jonas de Souza, MD
• COST-‐SHARING, PREMIUMS • INDIRECT COSTS (LOSS OF INCOME) • DIRECT NON-‐MEDICAL (CHILDCARE, ETC)
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The tip of the iceberg sinks the ship
VISIBLE TO THE PATIENTS • COST-‐SHARING, PREMIUMS • INDIRECT COSTS (LOSS OF INCOME) • DIRECT NON-‐MEDICAL (CHILDCARE, ETC)
BANKRUPTCY IN CANCER PATIENTS LINKED TO EARLY
MORTALITY (RAMSEY ET AL)
FINANCIAL BURDEN LINKED TO HRQOL
(ZAFAR ET AL) (FENN ET AL)
COST-SHARING RELATED TO ADHERENCE
(DUSETZINA ET AL)
Presented by: Jonas de Souza, MD
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“A cancer patient killed himself after he was told he had been “A cancer patient killed himself after he was told he had been refused a wonder drug by his local trust.” a wonder drug by his local trust.”
Ratain MJ: Biomarkers and Clinical Care. AAAS/FDLI Colloquium, Personalized Medicine in an Era of Health Care Reform, 2009
Financial Toxicity Grade 5?
Ratain MJ: Biomarkers and Clinical Care. AAAS/FDLI Colloquium, Personalized Medicine in an Era of Health Care Reform, 2009
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A PaIent-‐Centered View
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A lot, some, a liYle, not at all
From qualitaFve to quanFtaFve
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COST = COmprehensive Score for financial Toxicity
de Souza JA, Yap B, Hlubocky FJ, et al. The Development of a Financial Toxicity Patient Reported Outcome in Cancer: The COST Measure. Cancer. 2014. http://onlinelibrary.wiley.com/doi/10.1002/cncr.28814/abstract
A PaIent-‐Centered View Development of the COST-PROM
de Souza JA, Yap B, Hlubocky FJ, Cella D, Ratain MJ, Daugherty CK. The Development of a Financial Toxicity Patient Reported Outcome in Cancer: The COST Measure. Cancer. 2014. http://onlinelibrary.wiley.com/doi/10.1002/cncr.28814/abstract
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20 patients
35 patients
46 patients
100 patients 46 from step 3 plus 54 only for factor analysis
• PaIents with advanced cancers
• Who received chemotherapy for at least 3 months
• Last treatment not longer than 6 months prior to the assessment
A PaIent-‐Centered View Development of the COST-PROM – 1/4 steps
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20 patients
35 patients
46 patients
100 patients 46 from step 3 plus 54 only for factor analysis
• The qualitaIve interviews with 20 paIents, literature review and expert opinion resulted in 147 items
• A_er reducIon due to overlapping content, a total of 58 items were retained: 31 items from paIents, 25 items from the literature, 2 from experts • 58 items were classified into 8 financial items, 13 resource items, 17 affect items, 10 coping items, and 10 family items
58 items retained
A PaIent-‐Centered View Development of the COST-PROM – 1/4 steps
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A PaIent-‐Centered View Development of the COST-PROM – 2/4 steps
20 patients
35 patients
46 patients
100 patients 46 from step 3 plus 54 only for factor analysis
• Importance score = frequency x importance • Retain all items unIl at least 3 items per domain had been retained – 28 items excluded
• 30 items going to step 3
58 items retained
30 items retained
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A PaIent-‐Centered View Development of the COST-PROM – 3/4 steps
20 patients
35 patients
46 patients
100 patients 46 from step 3 plus 54 only for factor analysis
58 items retained
30 items retained
Inter-item correlation Item-total correlation
Preliminary factor analysis
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35 patients
46 patients
A PaIent-‐Centered View Development of the COST-PROM – 3/4 steps
• Following FACT formadng
• CollecIng sociodemographics
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A PaIent-‐Centered View Development of the COST-PROM – 3/4 steps
• Pairs of items with an IIC >0.7 were identified and, within each correlated pair, the item with the highest importance score in step 2 was retained
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A PaIent-‐Centered View Development of the COST-PROM – 3/4 steps
• Pairs of items with an IIC >0.7 were identified and, within each correlated pair, the item with the highest importance score in step 2 was retained
• Items with nonsignificant item-total correlations (ITCs) (ie, not significantly related to the instrument total score; P > .05) were excluded
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35 patients
46 patients
A PaIent-‐Centered View Development of the COST-PROM – 3/4 steps
• Interim factor analysis revealed 2 factors, an items/factor raIo of 6 and wide communaliIes
16 items retained
13 items retained
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A PaIent-‐Centered View Development of the COST-PROM – 3/4 steps
20 patients
35 patients
46 patients
100 patients 46 from step 3 plus 54 only for factor analysis
16 items retained
13 items retained
58 items retained
30 items retained
• Based on preliminary analysis, simulaIon work1 esImated a minimum of 95 paIents would be considered appropriate to factor analysis 1 - Mundfrom DJ, Shaw DG, Tian Lu K. Minimum sample size recommendations for conducting factor analyses. Int J Testing. 2005;5: 159-168.
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A PaIent-‐Centered View Development of the COST-PROM – 4/4 steps
20 patients
35 patients
46 patients +
54 patients
Factor Analysis
16 items retained
13 items retained
58 items retained
30 items retained
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A PaIent-‐Centered View Development of the COST-PROM – 4/4 steps
20 patients
35 patients
46 patients
100 patients 46 from step 3 plus 54 only for factor analysis
• Items with loadings less than 0.5 to be removed
• Two items removed: “My insurance does not provide adequate treatment coverage for my illness and care-‐related expenses” (0.44) “I rely on friends or family to help with the costs of health care” (0.43)
Final: 11 items
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COST = COmprehensive Score for financial Toxicity
• 11 items • 1-‐ factor soluIon explained 93% of variance in the data • Cronbach-‐alpha 0.9 • Mean IIC: 0.47 • Mean ITC: 0.71 • 1 financial item, 2 resources and 8 affect items
de Souza JA, Yap B, Hlubocky FJ, et al. The Development of a Financial Toxicity Patient Reported Outcome in Cancer: The COST Measure. Cancer. 2014. http://onlinelibrary.wiley.com/doi/10.1002/cncr.28814/abstract
A PaIent-‐Centered View Development of the COST-PROM
de Souza JA, Yap B, Hlubocky FJ, et al. The Development of a Financial Toxicity Patient Reported Outcome in Cancer: The COST Measure. Cancer. 2014. http://onlinelibrary.wiley.com/doi/10.1002/cncr.28814/abstract
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de Souza JA, Yap B, Hlubocky FJ, et al. The Development of a Financial Toxicity Patient Reported Outcome in Cancer: The COST Measure. Cancer. 2014. http://onlinelibrary.wiley.com/doi/10.1002/cncr.28814/abstract
de Souza JA, Yap B, Hlubocky FJ, et al. The Development of a Financial Toxicity Patient Reported Outcome in Cancer: The COST Measure. Cancer. 2014. http://onlinelibrary.wiley.com/doi/10.1002/cncr.28814/abstract
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Clinical Relevance?
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de Souza JA, Yap B, Hlubocky FJ, et al. The Development of a Financial Toxicity Patient Reported Outcome in Cancer: The COST Measure. Cancer. 2014. http://onlinelibrary.wiley.com/doi/10.1002/cncr.28814/abstract
A PaIent-‐Centered View COST-PROM - HRQOL
• Financial Toxicity (Hypotheses) • Correlates with HRQOL • Independent of mood states • Independent of personal adtudes or traits • Independent of willingness to discuss costs • Controlled for clinical trial parIcipaIon
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Approached: 375 paIents who have been on chemotherapy for at least 3 months
Agreed to ParFcipate: 236 paIents (62.9%)
Analyzed: 233 paIents (62.1%)
Withdrew: 3 paIents due to the financial nature of the study
(0.8%) Declined to ParFcipate: 139 paIents (37.1%)
233 patients with advanced stage cancers were recruited at UCM-affiliated centers
de Souza, J. A., Yap, B. J., Wroblewski, K., Blinder, V., Araújo, F. S., Hlubocky, F. J., Nicholas, L. H., O'Connor, J. M., Brockstein, B., Ratain, M. J., Daugherty, C. K. and Cella, D. (2017), Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer, 123: 476–484.
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Characteristics of respondents and non-respondents in the study
Respondents n = 233
Non-respondents n = 142
p-value Age (mean±SD) 58.4±11.5 63.6±12.8 <0.001 Gender
Female 136 (58.4%) 69 (48.9%) 0.08 Male 97 (41.6%) 72 (51.1%)
Marital Status Married 170 (73.3%) 87 (61.3%) 0.02 Divorced/separated/widowed 38 (16.4%) 26 (18.3%) Never married 24 (10.3%) 29 (20.4%)
Race/ethnicity Caucasian, non-Hispanic 154 (66.4%) 80 (56.3%) 0.07 Non-Caucasian 78 (33.6%) 62 (44.6%)
Insurance type Private or employer-based 144 (61.8%) 72 (50.7%) 0.07 Medicare (+ or - supplement) 73 (31.3%) 59 (41.6%) Medicaid 13 (5.6%) 11 (7.8%) COBRA continuation coverage 3 (1.3%) 0 (0.0%)
Household income (mean±SD)1 $68,107±28,232 $62,936±25,718 0.07 P-values are from t-tests or chi-square tests between participants and non-participants in the study.1 Income was based on Census Data related to a patient’s zipcode. !
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de Souza JA, Yap B, Hlubocky FJ, et al. The Development of a Financial Toxicity Patient Reported Outcome in Cancer: The COST Measure. Cancer. 2014. http://onlinelibrary.wiley.com/doi/10.1002/cncr.28814/abstract
A PaIent-‐Centered View COST-PROM - HRQOL
COST-PROM
HRQOL
Mood States
Social Desirability
OOP
Admissions
Compliance
Willingness to Discuss Costs
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de Souza JA, Yap B, Hlubocky FJ, et al. The Development of a Financial Toxicity Patient Reported Outcome in Cancer: The COST Measure. Cancer. 2014. http://onlinelibrary.wiley.com/doi/10.1002/cncr.28814/abstract
A PaIent-‐Centered View COST-PROM - HRQOL
COST-PROM
HRQOL
Mood States
Social Desirability
OOP
Admissions
Compliance
Willingness to Discuss Costs
• Brief POMS: r = -‐0.26, p <0.01
• Marlowe-‐Crowne Social Desirability: r= 0.16, p = 0.28
• FACT-‐G: r = 0.42, p < 0.001 • PWB: r = 0.35, p < 0.05 • SWB: r = 0.33, p < 0.05 • EWB: r= 0.32, p < 0.05 • FWB: r = 0.41, p < 0.01
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de Souza JA, Yap B, Hlubocky FJ, et al. The Development of a Financial Toxicity Patient Reported Outcome in Cancer: The COST Measure. Cancer. 2014. http://onlinelibrary.wiley.com/doi/10.1002/cncr.28814/abstract
A PaIent-‐Centered View COST-PROM - HRQOL
OOP
Admissions
Compliance
Willingness to Discuss Costs
• ParIal correlaIons • Age, ECOG PS • variables found to be significantly associated with COST on mulIvariate analyses:
• Income, employment, ethnicity, inpaIent admission, psychological distress
• FACT-‐G: 0.31, p<0.01
• EORTC: 0.20, p<0.001
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A PaIent-‐Centered View COST-PROM - HRQOL
COST-PROM Income (FPL)
OOP
Admissions
Compliance • r=0.28, p<0.01
ER visits
Admissions
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A PaIent-‐Centered View COST-PROM - Predictors
No statistically significant interactions were found, including the interaction between income and employment.
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• PaIent-‐centered • ScienIfically-‐derived • Correlated with a meaningful outcome (HRQoL)
A PaIent-‐Centered View COST-PROM
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• PaIent-‐centered • ScienIfically-‐derived • Correlated with a meaningful outcome (HRQoL)
Useful in clinic or research?
A PaIent-‐Centered View COST-PROM
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ApplicaIon Cross-‐secIonal Studies in Single Diseases
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ApplicaIon Understanding Cost Discussion Preferences
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ApplicaIon Understanding Cost Discussion Preferences
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Preferred Cost Communicator: Who do you want to talk to about costs?
Note: 3% of patients selected “other” as their preferred cost communicator. “Other” responses included: “expert in the hospital”, “hospital administrator”, “I don’t know”, “Medicare/Medicaid”, “whoever can negotiate with insurance” and 2 responses of “insurance company employee”.
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Preferred Cost Communicator: Who do you want to talk to about costs?
• Physician: – PaIents with less financial toxicity are more likely to want to discuss
costs with their physician (OR= 1.02, p=0.05) – Those on oral drugs are 3.4 Fmes more likely than those on IV therapy to
want to talk to their physicians about costs (p=0.005)
• Social Worker: – PaIents with increased financial toxicity are more likely to want to speak
to a social worker (OR= 0.97, p=0.04) – Non-‐Caucasians are 2.26 Fmes more likely to want to speak to a Social
Worker (p=0.01)
• Financial Counselor: – A trend is seen; paIents who want to speak to a financial counselor have
increased financial toxicity (OR=0.60, p=0.16)
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Preferred Cost Communicator: Who do you want to talk to about costs?
• Physician: – PaIents with less financial toxicity are more likely to want to discuss
costs with their physician (OR= 1.02, p=0.05) – Those on oral drugs are 3.4 Fmes more likely than those on IV therapy to
want to talk to their physicians about costs (p=0.005)
• Social Worker: – PaIents with increased financial toxicity are more likely to want to speak
to a social worker (OR= 0.97, p=0.04) – Non-‐Caucasians are 2.26 Fmes more likely to want to speak to a Social
Worker (p=0.01)
• Financial Counselor: – A trend is seen; paIents who want to speak to a financial counselor have
increased financial toxicity (OR=0.60, p=0.16)
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Preferred Cost Communicator: Who do you want to talk to about costs?
• Physician: – PaIents with less financial toxicity are more likely to want to discuss
costs with their physician (OR= 1.02, p=0.05) – Those on oral drugs are 3.4 Fmes more likely than those on IV therapy to
want to talk to their physicians about costs (p=0.005)
• Social Worker: – PaIents with increased financial toxicity are more likely to want to speak
to a social worker (OR= 0.97, p=0.04) – Non-‐Caucasians are 2.26 Fmes more likely to want to speak to a Social
Worker (p=0.01)
• Financial Counselor: – A trend is seen; paIents who want to speak to a financial counselor have
increased financial toxicity (OR=0.60, p=0.16)
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• CollaboraIon with the North American Thyroid Cancer Survivorship Study
• 591 paIents with thyroid cancer within the past 6 years were surveyed in 2 countries:
– 553 (93.6%) in the U.S., and 38 (6.4%) in Canada
• In mulIvariate analyses, the independent predictors of worse Financial Toxicity were lower income (p < 0.001), female gender (p = 0.01), lower educaIonal level (p=0.002), treatment in the U.S., (p=0.002), and worse HRQoL (p<0.001)
ApplicaIon Comparison of Distress Between Countries
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www.costofcancercare.org
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www.costofcancercare.org (as of Feb 2017)
� Agreement with Patient Access Network Foundation � All patients received co-pay assistance � Patients assessed at baseline, 1-month, 3-month and
6-month � 308 patients with baseline, 1-month and 3-month
data
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www.costofcancercare.org (as of Feb 2017)
� COST changes over time!
� COST (FT) improved over 3 months
� HRQoL did not improve
Validation sample: mean COST ± SD, 22.23 ± 11.89)
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www.costofcancercare.org (as of Feb 2017)
� Score changes over time! � Can find out why their
financial toxicity improved? � Self-report use of
navigators, financial counselors, transportation vouchers, support groups
� Or only the copay assistance?
Validation sample: mean COST ± SD, 22.23 ± 11.89)
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www.costofcancercare.org (as of Feb 2017)
� 179 pts (42%) had a navigator, 106 (34%), a social worker, 107 (35%), a financial counselor, 94 (31%) a support group, and 50 (16%), received a transportation voucher
� None of these “interventions” were associated with improved financial toxicity
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www.costofcancercare.org (as of Feb 2017)
� 179 pts (42%) had a navigator, 106 (34%), a social worker, 107 (35%), a financial counselor, 94 (31%) a support group, and 50 (16%), received a transportation voucher
� None of these “interventions” were associated with improved financial toxicity
� Annals of obvious research: in a selected population of patients seeking help to pay for their drugs, nothing much helps but paying for their drugs!
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COST
FACT-G
Grade 0 Financial Toxicity
Grade 1
Grade 2
Grade 3
Hig
her b
ette
r qua
lity
of li
fe
Sig
nific
ant a
nd M
eani
ngfu
l
CTCAE (Common Terminology Criteria for Adverse Events) • Grade 0, none • Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic
observations only; intervention not indicated. • Grade 2 Moderate; minimal, local or noninvasive intervention indicated • Grade 3 Severe or medically significant but not immediately life-threatening
ApplicaIon Grading Financial Toxicity
Currently about 865 paIents
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Future direcIons
� ICD10 code for financial toxicity
� Post-marketing measurement � A PRO to be required in the post-approval drug
process?
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Future direcIons My Dream Approach to Financial Toxicity
(aka “my interrupted project”)
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� We are making progress in survival and outcomes
� We do expensive things to our patients � Let’s not ever forget how we also impact
their finances � Let’s use science and evidence to develop
solutions
In Summary
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Table 1: Demographics, Part 1 Survey Participants (n=233)
Age Mean, median [Range]
58.4, 59 [27-88]
Sex Female Male
58.4% (136) 41.6% (97)
Race Caucasian, Non-Hispanic Non-Caucasian
66.4% (154) 33.6% (78)
Employment Status Working (Full or Part-Time) Unemployed Retired Disability Other
33.6% (78) 9.1% (21) 32.8% (76) 19.4% (45) 5.1% (12)
Education Level Less than college Some college Completed college or higher
22.3% (52) 30.5% (71) 47.2% (110)
Marital Status Married/Cohabitating Divorced/Widowed/Separated Single, Never Married
73.3% (170) 16.4% (38) 10.3% (24)
Insurance Type Private/Employer Insurance Medicare Medicaid COBRA
61.8% (144) 31.3% (73) 5.6% (13) 1.3% (3)
Clinical Trial Status Yes No
27.9% (65) 72.1% (168)
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Table 1: Demographics, Part 2 Survey Participants (n=233)
Length of Disease < 1 year > 1 year
38.6% (90) 61.4% (143)
Line of Therapy Adjuvant/Neoadjuvant 1st Line Metastatic 2nd Line Metastatic 3rd Line Metastatic 4th Line Metastatic or Later
20.2% (47) 35.6% (83) 18.9% (44) 13.7% (32) 11.6% (27)
COST Score Mean, median [Range]
22.2, 23 [0-44]
Financial Well Being Score Mean, median [Range]
5.8, 5.5 [1-10]
FACT-G Quality of Life Score Mean, median [Range]
77.0, 79 [23.8-108]
EORTC Quality of Life Score Mean, median [Range]
61.5, 66.7 [0-100]
Income- Median Zip Mean, median [Range]
$68,048.9, $60,325 [$21,155-$201,354]
Income- Final Mean, median [Range]
$90,003.9, $67,282 [$0-$1,600,000]
Federal Poverty Level Mean 25th Percentile 50th Percentile 75th Percentile
514.6% 276.3% 376.7% 555.5%
Treatment Center University of Chicago Hospitals* NorthShore University Health System
85.4% (199) 14.6% (34)
Treatment Mode of Administration Oral Drug Only IV Drug (IV Drug Only or in Combination with Oral)
12.0% (28) 88.0% (205)
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CommunicaFon Preferences: My doctor should consider my out-‐of-‐pocket costs as
he/she makes medical decisions
Knowledge/Experience: My doctor knows how much I am spending on
out-of-pocket medical costs.
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Scores Survey Participants (n=233)
COST Score Median [Range]
23 [0-44]
POMS Median [Range]
14 [1-50]
FACT-G Quality of Life Score Median [Range]
79 [23.8-108]
EORTC Quality of Life Score Median [Range]
66.7 [0-100]
Median Scores