Out-of-pocket costs and financial toxicity experienced by patients in early-phase clinical trials.

2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 8-8
Author(s):  
Ryan Huey ◽  
Goldy George ◽  
Penny Phillips ◽  
Revenda White ◽  
Siqing Fu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Economic Burden ◽  
Therapeutic Option ◽  
Financial Burden ◽  
Medical Costs ◽  
Financial Toxicity ◽  
Phase I Clinical Trials ◽  
Medical Expenses ◽  
Early Phase Clinical Trials

8 Background: Clinical trials are an important therapeutic option for cancer patients. Although financial burden in cancer treatment is well-described, the financial burden associated with clinical trials is not well understood, especially for patients with lower socioeconomic status. Methods: We conducted a survey regarding economic burden and financial toxicity among cancer patients on Phase I clinical trials for at least 1 month. Financial Toxicity Score (FTS) was assessed using the validated COmprehensive Score for Financial Toxicity (COST) survey (scale 0-44, lower scores indicating worse financial toxicity). Patients also reported monthly out of pocket (OOP) medical and non-medical expenses. Results: Of 147 consecutive patients approached, 105 agreed to participate; median age = 60y; 62% female; 49% had annual income < $60K; 50% lived < 300 miles from the clinic; 34% required air travel; 41% had Medicare, 50% had employer sponsored insurance. Median FTS = 20, with interquartile range of 12.5. Median monthly OOP costs for non-medical expenses was $985, and for medical expenses was $475. Median total monthly OOP costs was $1695. Compared to patients in the highest quartile of FTS, a significantly lower % of patients in the lowest (worst) quartile of FTS had incomes > $60K (27% v. 77%, P < 0.001), and a significantly higher % were unemployed or not working outside the home (54% v. 12%, P = 0.001), and incurred higher than expected medical (39% vs. 12%, P = 0.025) and non-medical (64% vs. 15%, P = 0.003) expenses. Compared with patients for whom medical costs were not much higher than expected, a significantly higher % of patients with medical costs much higher than expected were non-White (77% v. 46%, P = 0.004) and unemployed/not working outside the home (46% v. 19%, P = 0.009). Conclusions: Among cancer patients participating on clinical trials, economic burden is high and financial toxicity is disproportionally higher in patients with lower income. OOP costs can be substantial and are often unexpected for patients.

Out of pocket costs and financial toxicity experienced by patients in early phase clinical trials.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18383-e18383
Author(s):  
Ryan Huey ◽  
Goldy George ◽  
Penny Phillips ◽  
Revenda White ◽  
Siqing Fu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Economic Burden ◽  
Therapeutic Option ◽  
Financial Burden ◽  
Medical Costs ◽  
Financial Toxicity ◽  
Phase I Clinical Trials ◽  
Medical Expenses ◽  
Early Phase Clinical Trials

e18383 Background: Clinical trials are an important therapeutic option for cancer patients. Although financial burden in cancer treatment is well-described, the financial burden associated with clinical trials is not well understood, especially for patients with lower socioeconomic status. Methods: We conducted a survey regarding economic burden and financial toxicity among cancer patients on Phase I clinical trials for at least 1 month. Financial Toxicity Score (FTS) was assessed using the validated COmprehensive Score for Financial Toxicity (COST) survey (scale 0-44, lower scores indicating worse financial toxicity). Patients also reported monthly out of pocket (OOP) medical and non-medical expenses. Results: Of 147 consecutive patients approached, 105 agreed to participate; median age = 60y; 62% female; 49% had annual income < $60K; 50% lived < 300 miles from the clinic; 34% required air travel; 41% had Medicare, 50% had employer sponsored insurance. Median FTS = 20, with interquartile range of 12.5. Median monthly OOP costs for non-medical expenses was $985, and for medical expenses was $475. Median total monthly OOP costs was $1695. Compared to patients in the highest quartile of FTS, a significantly lower % of patients in the lowest (worst) quartile of FTS had incomes > $60K (27% v. 77%, P < 0.001), and a significantly higher % were unemployed or not working outside the home (54% v. 12%, P = 0.001), and incurred higher than expected medical (39% vs. 12%, P = 0.025) and non-medical (64% vs. 15%, P = 0.003) expenses. Compared with patients for whom medical costs were not much higher than expected, a significantly higher % of patients with medical costs much higher than expected were non-White (77% v. 46%, P = 0.004) and unemployed/not working outside the home (46% v. 19%, P = 0.009). Conclusions: Among cancer patients participating on clinical trials, economic burden is high and financial toxicity is disproportionally higher in patients with lower income. OOP costs can be substantial and are often unexpected for patients.

Patient-reported out-of-pocket costs and financial toxicity during early-phase oncology clinical trials.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 7082-7082
Author(s):  
Ryan Huey ◽  
Goldy George ◽  
Penny Phillips ◽  
Revenda White ◽  
Siqing Fu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Phase I ◽  
Economic Burden ◽  
Early Phase ◽  
Financial Burden ◽  
Medical Costs ◽  
Lower Income ◽  
Financial Toxicity ◽  
Medical Expenses

7082 Background: Clinical trials are an important therapeutic option for cancer patients (pts). Although financial burden in cancer treatment is well-documented, the financial burden associated with clinical trials is not well understood, especially for pts with lower income. Methods: We conducted a survey regarding economic burden and financial toxicity in cancer pts who had been on Phase I clinical trials for ≥1 month. Financial Toxicity Score (FTS) was assessed using the validated COmprehensive Score for Financial Toxicity (COST) survey (scale 0-44, lower scores indicate worse toxicity). Pts also reported monthly out-of-pocket (OOP) medical and non-medical expenses. We applied multivariable logistic regression to analyze risk of financial toxicity, and unanticipated expenses. Results: Early-phase clinical trial pts (N = 213, median age = 59y; 59% female; 74% White, 45% w/ annual income ≤$60K; 50% lived > 300 miles from the clinic; 40% required air travel; 37% had Medicare, 54% had employer sponsored insurance) had a median FTS of 20, with interquartile range of 12. Median monthly OOP costs for non-medical expenses was $1075, and for medical expenses was $475. Median total monthly OOP costs was $1750. 55% and 64% of pts reported that actual medical and non-medical expenses were higher than expected, respectively. Worse financial toxicity (≤ median FTS) in pts was associated with yearly household income < $60K (OR: 2.7, P = 0.008), having medical costs higher than expected (OR: 3.2, P = 0.024), participation on ≥1 Phase I clinical trial prior to their current trial (OR: 2.2, P = 0.028), and living > 100 miles away from the clinical trials hospital (OR: 2.3, P = 0.043). However, 34% of pts who lived > 100 miles away received partial/full reimbursement of clinical trial-related travel costs from study sponsor/other/insurance. Racial/ethnic minority (OR: 2.6, P = 0.008) and pts who were unemployed or not working outside the home (OR: 2.4, P = 0.023) were more likely to report that actual medical costs were much higher than expected. 53% of pts used savings and 18% retirement accounts to pay for treatment. Conclusions: Among cancer pts participating on clinical trials, economic burden is high, and most of pts’ OOP costs were on non-medical expenses. Financial toxicity is disproportionally higher in pts with lower income. OOP costs can be substantial and are often unexpected for pts. Furthermore, prior participation in ≥1 Phase I clinical trial and living far away from the clinical trials hospital seem to increase risk of financial toxicity.

scholarly journals Time to progression ratio in cancer patients enrolled in early phase clinical trials: time for new guidelines?

2018 ◽  
Vol 119 (8) ◽  
pp. 937-939 ◽  
Author(s):  
Sarah Watson ◽  
Jessica Menis ◽  
Capucine Baldini ◽  
Patricia Martin-Romano ◽  
Jean-Marie Michot ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Early Phase ◽  
Time To Progression ◽  
New Guidelines ◽  
Early Phase Clinical Trials

Prognostic factors for cancer patients with good performance status considered for inclusion in phase I clinical trials

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2568-2568
Author(s):  
M. Bonneterre ◽  
N. Penel ◽  
M. Vanseymortier ◽  
E. Dansin ◽  
S. Clisant ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Prognostic Factors ◽  
Serum Albumin ◽  
Phase I ◽  
Cancer Patients ◽  
Cox Model ◽  
Performance Status ◽  
Univariate Analysis ◽  
Rank Test ◽  
Phase I Clinical Trials

2568 Background: For investigators, the selection of patients to be considered for phase I clinical trials is difficult, because of the lack of objective criteria for a rational decision-making process. From October 1997 to October 2002, we retrospectively assessed prognostic factors for cancer patients considered for Phase 1 trials. Methods: 148 consecutive patients who had been screened for inclusion in 6 different phase I trials were included in the present study. 70 out of them actually received the phase I treatment. Univariate (Log-Rank test) and multivariate analysis (Cox proportional hazard ratio model) were performed to determine the prognostic factors related to overall survival (OS) after screening. Results: The study comprised 63 men and 85 women, with a median age of 54 (range 23–79). The most frequent primary cancer sites were: breast (38 cases), head and neck (28 cases), lung (18 cases) and colorectal (17 cases). 91 out of them had a performance status PS = 0. The median OS of the 148 patients was 5.7 months (173 days, range 1–2,421). Univariate analysis identified PS = 1, Body Mass Index < 20, liver and visceral metastasis, serum albumin < 38 g/L, lymphocytes count < 0.7 x 109/L and granulocytes count > 7.5 x 109/L as poor prognostic factors. The Cox model identified serum albumin < 38 g/L (HR 2.51 [1.51–4.18], p=0.0001) and lymphocyte count < 0.7 x 109/L (HR 2.27 [1.13–4.62], p=0.024) as independent prognostic variables for OS. All patients presenting with both prognostic factors died within 90 days. Conclusion: We propose a simple model, easily obtained at the patient bedside, which can discriminate patients who have a life expectancy of over 3 months and thus could be enrolled in phase-I anti-cancer trials. No significant financial relationships to disclose.

Increased access for and enhancement of cancer (ca) patients (pts) participation (par) in clinical trials (cts) by alleviation of financial toxicity.

2018 ◽  
Vol 36 (7_suppl) ◽  
pp. 24-24 ◽  
Author(s):  
Edith P. Mitchell ◽  
Dana Dornsife
Keyword(s):  
Clinical Trials ◽  
Financial Burden ◽  
Community Outreach ◽  
Financial Toxicity ◽  
Financial Outcomes ◽  
Travel Costs ◽  
Care Giving ◽  
Barriers To Enrollment ◽  
Asian Pacific ◽  
Age Range

24 Background: Prognosis for pts is increasing as a result of advances in cts. However, the degree to which cancer caused financial problems may influence ca pts par in cts and negatively impact quality of life. Excess financial burden of cts par, may include finding an appropriate trial, traveling to the trial site, travel costs, lodging and medical expenses. The Lazarex Cancer Foundation (LCF) was founded in 2006 with mission to improve care, giving hope, dignity, and life to advanced ca pts by providing assistance with options and costs to cts par, community outreach, and education. LCF developed processes to removing the barriers to cts par by improving equitable access to cancer care, increasing cts enrollment, retention and minority par, and increasing cts referrals. Methods: To determine the extent of benefit of LCF, we conducted a retrospective analysis of LCF beneficiaries participating in cts by reviewing and summarizing the number of pts, states and countries of residence, age, type of cancer, location and distance to cts site, type of assistance, and number of advocacy/outreach. Results: From 1/01/2010 – 12/31/2016 2179 pts were assisted financially; age range 1-102 yrs, median 50-60; (43%) male, (53%) female, (3.4%) undeclared. (6.4%) were African American, 10.3% Hispanic, 3.6 Asian Pacific Islander, other minority 2.1, and Caucasian 72.7%;total minority 22.5%. Pts resided in 50 states with largest CA , TX , MA , and FL. Cts were at 199 sites – 43 NCI CCC, 7 NCI DCC and 149 other cancer centers. Most common diagnoses were breast, leukemia, colorectal cancers. type tumors. Median household income was $75,000. Financial assistance to travel to and living expenses at the cts site was the most frequently identified need. Conclusions: Relieving pts of financial burden allows greater access to and participation in cancer clinical trials. Further research and greater resources are needed to define patient needs and determine methods to eliminate barriers to enrollment and retention investigate coverage thresholds that minimize adverse financial outcomes and identify ca pts at greatest risk for financial toxicity to increase par in cts.

Integration of specialty palliative care in a phase I ovarian cancer population.

2019 ◽  
Vol 37 (31_suppl) ◽  
pp. 75-75
Author(s):  
Marisa R Moroney ◽  
Breana Hill ◽  
Jeanelle Sheeder ◽  
Jennifer Robinson Diamond ◽  
Melony Avella-Howell ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Palliative Care ◽  
Clinical Trials ◽  
Phase I ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Disease Stage ◽  
Phase I Clinical Trials ◽  
Care Services ◽  
Palliative Care Services

75 Background: ASCO guidelines recommend patients with advanced cancer receive early integrated specialty palliative care based on evidence of multiple clinical benefits. To our knowledge, there is no literature evaluating utilization of specialty palliative care in Phase I clinical trial patients, but there is limited data demonstrating underutilization of palliative care services in patients with life-threatening diseases including advanced cancer. Methods: A retrospective review of ovarian cancer patients enrolled in Phase I clinical trials at one institution from 2008 to 2018. Charts were reviewed for patient and disease characteristics including age, disease stage, number of chemotherapy regimens and date of death. Charts were also reviewed to determine if and when patients received specialty palliative care services. Results: A total of 121 patients with ovarian cancer were enrolled in Phase I clinical trials. Median age at time of Phase I enrollment was 59 years (range 33-88). 87% of patients had advanced stage disease: 60% Stage III and 27% Stage IV. Median number of chemotherapy regimens received prior to Phase I enrollment was 5 (range 1-13). Median survival was 311 days (95%CI 225.9-396.1). Of the 121 patients, 4 (3.3%) received specialty palliative care prior to Phase I enrollment, 7 (5.8%) within 30 days after enrollment, and 53 (43.8%) more than 30 days after enrollment. 57 patients (47.1%) never received specialty palliative care. Conclusions: Ovarian cancer patients enrolled in Phase I clinical trials have advanced cancer – defined by ASCO as disease that is late-stage and life limiting with a prognosis less than 24 months – and should therefore receive early integrated specialty palliative care. This study demonstrates that a significant portion of Phase I ovarian cancer patients are either receiving no or late integration of specialty palliative care. Further work needs to focus on increasing early integration of specialty palliative care in this population.

Financial toxicity and its associated patient and cancer factors among women with breast cancer in China.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19402-e19402
Author(s):  
Jingfeng Jing ◽  
Ran Feng ◽  
Xiaojun Zhang ◽  
Ming Li ◽  
Jinnan Gao
Keyword(s):  
Breast Cancer ◽  
Regression Analysis ◽  
Linear Regression ◽  
Cancer Treatment ◽  
Cancer Patients ◽  
Linear Regression Analysis ◽  
Cancer Stage ◽  
Financial Toxicity ◽  
Medical Expenses ◽  
The Cost

e19402 Background: The term “Financial toxicity(FT)” is widely used to describe the distress or hardship patients suffering from the financial burden of cancer treatment[1]. Increased evidences have showed that cancer-associated FT is common and has a negative impact on patients’ mental health, quality and length of life[1,2]. The scale of COmprehensive Score for financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) was used to assess the FT of cancer patients, which has been validated and widely used internationally [3] and China [4]. To our knowledge, little is known about the FT of breast cancer patients in China. The aim of this study is to assess the FT and to investigate patients and cancer characteristic that associated with it in patients in central China. Methods: This was a cross-sectional study among 188 patients with stage 0-III women breast cancer admitted in Bethune hospital in Taiyuan, Shanxi province during January - May 2019. FT was self-reported using the COST-FACIT. Patients’ socio-demographic factors, clinical examination, and cancer treatment were collected from questionnaire and hospital record. The financial concern and coping strategy was self-reported. Factors associated with FT was identified using linear regression analysis. Results: One hundred and sixty-six (88.2%) completed the questionnaire. The COST score ranged 0-40 with a mean of 21.2 (median 22.5, standard deviation 8.1). On multivariate linear regression analysis, older age (β coefficient: 0.19, 95% CI: 0.10-0.29, p<0.001), higher household income (β coefficient: 3000-5000 Yuan: 6.48, 95% CI: 2.78-10.17, p =0.001; ≥ 5000 Yuan: 11.17, 95% CI: 7.25-15.09, p<0.001) were positively associated with COST scores. Advanced cancer stage was the strongest predictor of FT among the cancer characteristics (β coefficient: -1.81, 95% CI: -3.17, -0.46, p=0.009). To cope with the FT, 131 (78.8%) patients decreased non-medical expenses, and 56 (33.7%) reduced or quit treatment. Conclusions: FT was significantly associated with patient’s age, income, and cancer stage. Women having financial concerns after diagnosis were more likely to reduce their non-medical expenses and even quit treatments. Clinicians should take into account the FT levels in all patients and work out appropriate treatment strategies for optimal clinical outcome.

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