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| ORIGINAL ARTICLE |
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| Year : 2020 | Volume
: 3
| Issue : 4 | Page : 724-729 |
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Financial toxicities in patients receiving systemic therapy for brain tumors: A cross-sectional study
Devanshi Kalra, Nandini Menon, Gunjesh Kumar Singh, Ochin Dale, Supriya Adak, Sudeep Das, Sujay Srinivas, Dilip Harindran Vallathol, Vijay M Patil
Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India
| Date of Submission | 03-Aug-2020 |
| Date of Decision | 26-Sep-2020 |
| Date of Acceptance | 04-Dec-2020 |
| Date of Web Publication | 25-Dec-2020 |
Correspondence Address:
Vijay M Patil
Department of Medical Oncology, Tata Memorial Hospital Parel, Mumbai, Maharashtra
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/CRST.CRST_265_20
Background: Apart from disease management and the toxicities of systemic therapy, financial burden is an additional liability in patients with brain tumors receiving systemic therapy. However, currently, there is a paucity of data on the financial toxicities incurred by these patients.
Objectives: In this study, we aimed to assess the perceived financial toxicity and the quality of life (QOL) of patients with brain tumors receiving systemic therapy and to evaluate the factors affecting it.
Materials and Methods: This single-center, cross-sectional study was conducted in the Department of Medical Oncology at the Tata Memorial Hospital in Mumbai, India, between January 2019 and March 2019. The financial toxicity scores (FTSs) were captured at a single visit from the patients with primary brain tumors with or without recurrence who visited the Neuro Medical Oncology Outpatient Department. The Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy and Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaires were used to collect data on the FTS and QOL, respectively. Pearson correlation coefficient was used to determine the correlation between FTS and the various domains of QOL. Multiple linear regression was used to determine the factors that influence FTS, and P < 0.05 was considered statistically significant.
Results: A total of 147 patients were included in the study; the median age of the cohort was 38 years (range, 16–67). Of them, 102 (67.5%) were men and 48 (32.5%) were women. The median monthly income was ₹7000 ($92.75). The median FTS was 13 (interquartile range [IQR], 6–21). The associated risk factors for financial toxicity were age (beta = 0.242,P = 0.001), category under which the patient availed treatment – private (regular cost) or general (discounted cost) (beta = 0.398, P < 0.001), and disease status (beta = −0.151,P = 0.043). The median FACT-General score, FACT-Br Trial Outcome Index score, and FACT-Br Total score were 77.2 (IQR, 64-91.7), 92.89 (IQR, 73.16–107), and 131.5 (IQR, 107.33–150.9), respectively, and were significantly associated with FTS ( P < 0.001).
Conclusions: Financial distress was found to be severe in patients with brain tumors receiving systemic therapy. The age, payment category under which the patients availed treatment, and the disease status were found to be contributory factors. These, along with the QOL, were significantly associated with FTS.
Keywords: Brain tumors, Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy, financial toxicity, oncology
How to cite this article:
Kalra D, Menon N, Singh GK, Dale O, Adak S, Das S, Srinivas S, Vallathol DH, Patil VM. Financial toxicities in patients receiving systemic therapy for brain tumors: A cross-sectional study. Cancer Res Stat Treat 2020;3:724-9 |
How to cite this URL:
Kalra D, Menon N, Singh GK, Dale O, Adak S, Das S, Srinivas S, Vallathol DH, Patil VM. Financial toxicities in patients receiving systemic therapy for brain tumors: A cross-sectional study. Cancer Res Stat Treat [serial online] 2020 [cited 2021 Jan 26];3:724-9. Available from: https://www.crstonline.com/text.asp?2020/3/4/724/304958 |
| Introduction | |  |
Systemic treatment of brain tumors is associated with complexities. Apart from these complexities and the adverse effects of systemic therapy, the patients have to incur a significant financial burden.[1] There have been remarkable advances in cancer treatment yielding improvements in patient outcomes, but these improvements have come at an increasing cost.[2] As a result of the continued hike in the cost of cancer treatment, financial toxicity has become an important consideration in recent cancer care.[1] Financial toxicity refers to the problems faced by the patients, related to the cost of medical care. Financial toxicity also affects the patients' quality of life (QOL) and access to medical care.[1] However, there is scarce literature on the financial toxicity experienced by patients receiving systemic therapy for brain tumors.[3]
The financial impact on a patient diagnosed with cancer can be significant. The magnitude of the financial burden due to cancer is determined by numerous factors, which primarily include the household income, insurance status, socioeconomic status, and the extent of disease.[4] Cancer-related financial stress is multifactorial. The cost of various treatment modalities such as chemotherapy, radiotherapy, and surgery as well as that of home health care and travel to treatment centers can be substantial.[4] Employed patients may experience loss of productivity at work or, at times, a total loss of employment and work-related benefits.[4]
The Government of India offers several schemes for below-poverty-line patients like the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana, which gives a total benefit of ₹500,000 ($6799.48) per family per year for treatment. At our institution as well, the Mahatma Jyotiba Phule Jan Arogya Yojana provides health coverage for a total of ₹150,000 ($2000) per patient. Nearly half of the Indian population belongs to the middle class (i.e., those spending between $2 [₹147.5] and $10 [₹737.73] per capita per day).[5] These patients do not benefit from the government schemes and often do not have any health insurance policies, which becomes a hindrance in getting appropriate treatment. Based on various studies, financial stress has been linked to several clinically relevant patient outcomes, including the health-related QOL, symptom burden, compliance, and survival.[6]
Various studies have been conducted to evaluate the financial burden incurred by the patients undergoing treatment for cancer,[2],[6] but there are limited data when it comes to assessing the financial toxicity in patients with brain tumors undergoing systemic therapy. Therefore, we performed a cross-sectional analysis of the financial toxicities experienced by our patients with brain tumors receiving systemic therapy.
| Methods | | |
General study details
This was a single-center, cross-sectional study conducted in the Department of Medical Oncology at the Tata Memorial Hospital, a tertiary cancer center in Mumbai, India. Patients with primary brain tumors with or without recurrence, who visited the Neuro Medical Oncology Unit of the Department of Medical Oncology between January 2019 and March 2019, were invited to participate in this study. The Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) questionnaire was administered in an attempt to identify the obstacles that patients faced and to improve the routine care offered by the unit. The study did not require approval from the institutional ethics committee, and therefore, ethical clearance was not obtained. No longitudinal data were collected, and none of the patients were contacted after their single visit for the current study. All patients provided verbal informed consent before enrollment in the study. The principles of the Declaration of Helsinki, Good Clinical Practice, and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use were followed.
Participants
Patients aged 18 years and above with a biopsy-proven brain tumor and an Eastern Cooperative Oncology Group performance score (ECOG PS) of 0–3 were included in the study. The ECOG PS is a scale that measures the functioning of a person; the score ranges from 0 to 5, where a score of 0 is assigned to a person who is fully active and able to carry on all the predisease activities without restriction and a score of 5 indicates death. Patients availing treatment under the general as well as the private categories as registered in the hospital participated in the study. At our hospital, the patients in the general category need to pay a minimum or no charge for consultation and investigations, whereas those in the private category have to pay in full for the consultations and investigations. Patients who did not understand English/Hindi/local language were not included in the study.
Variables
Our primary endpoint was to estimate the mean financial toxicity score (FTS) in patients with brain tumors receiving systemic therapy. Our secondary endpoint was to evaluate the factors affecting the FTS.
Study methodology
All consecutive patients with brain tumors who fulfilled the eligibility criteria were administered the COST-FACIT, version 2, and the Functional Assessment of Cancer Therapy-Brain (FACT-Br, version 4) questionnaires. These were used to collect data with regard to the FTS and the QOL, respectively, in real time during a private interview session in which the patients completed the FACT-Br and COST-FACIT questionnaires.
The COST-FACIT questionnaire has 12 questions. It was developed by De Souza et al. and validated to assess the degree of financial distress experienced by patients with cancer. The score ranges between 0 and 44, and a higher score implies better financial well-being.[6] Although there is no cutoff score established, D'Rummo et al. used a grading system with Grade 0 (COST score ≥26), Grade 1 (14–25), Grade 2 (1–13), and Grade 3 (0).[7] The FACT-Br scores contain the following subscales: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), and functional well-being (FWB); the FACT-General (FACT-G) score; brain cancer subscale (BrCS); FACT-Br Trial Outcome Index (TOI); and the FACT-Br Total score. The FACT-Br scale has 51 questions. Out of these, 7 are regarding PWB, 8 are about SWB, 6 are on EWB, 7 are on FWB, and 23 are regarding additional concerns, which is BrCS. The FACT-G score is obtained by adding together the PWB, SWB, EWB, and FWB scores. The FACT-Br TOI was obtained after adding together the PWB, FWB, and BrCS, and the FACT-Br Total score was obtained by adding the FACT-G and the BrCS scores.
The FACT-G scoring system assesses the impact of cancer and its treatment on the QOL in four domains: physical, social, emotional, and functional. The BrCS scale is used to assess the symptoms commonly reported by patients with brain tumors. Higher scores on each subscale indicate a better QOL. Patients were encouraged to answer all the questions. The patients who could understand English answered the questions themselves. The patients who could not understand the questions were helped to fill up the questionnaires by the administrator.
Statistics
No formal sample size calculation was done; rather, a convenience sampling was performed. The baseline characteristics, diagnosis, chemotherapy details, and answers to the questionnaire were entered in Microsoft Excel and cross-evaluated by two separate persons. The Statistical Package for the Social Sciences (SPSS) version 20 (IBM Corp., Released 2011. IBM SPSS Statistics for Windows, version 20.0. Armonk, NY: USA, IBM Corp.) was used for the analysis. A descriptive analysis was performed. The medians with the interquartile ranges (IQR) were used. Pearson correlation analysis was performed, and the Pearson correlation coefficient between the FTS and various domains of the QOL was estimated. Multiple regression analysis was performed to identify the factors affecting financial toxicity. These factors were age, sex (male versus female), monthly income, category (general or private), and disease status (recurrence versus no recurrence). P < 0.05 was considered statistically significant.
| Results | | |
Baseline characteristics
There were a total of 147 patients in the cohort [Figure 1], and their median to 38 years. (range, 16–69) years. Of these, 102 (67.5%) were men and 45 (32.5%) were women. Temozolomide was the most common (80.3%) regimen (concurrent, adjuvant, and salvage) used. The median monthly income of the patients was ₹7000 ($92.75). The additional details of baseline characteristics are provided in [Table 1].
Functional Assessment of Cancer Therapy-Brain scores, financial toxicity scores, and their relationship
The median PWB was 21 (IQR, 15–25), the median EWB was 19 (IQR, 15–22), the median FWB was 19 (IQR, 14–23), the median SWB was 22.4 (IQR, 17.5–26.6), and the median FACT-G score was 77.2 (IQR, 64–91.66). The median FACT-Br TOI score and median FACT-Br Total score were 92.89 (IQR, 73.16–107) and 131.5 (IQR, 107.33–150.9), respectively. The median FTS was 13 (IQR, 6–21) [Table 2]. There was a significant correlation between FTS and FACT-Br TOI ( P < 0.001), FACT-G ( P < 0.00), and FACT-Br Total ( P < 0.001) [Figure 2], [Figure 3], [Figure 4]. | Figure 2: Correlation between Functional Assessment of Cancer Therapy-Brain Trial outcome index and financial toxicity scores
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 | Figure 3: Correlation between Functional Assessment of Cancer Therapy-General and financial toxicity scores
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 | Figure 4: Correlation between Functional Assessment of Cancer Therapy-Brain Total and financial toxicity scores
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We applied the grading scale that was used by D'Rummo et al. and found Grade 0, 1, 2, and 3 financial toxicity in 19 (12.92%), 52 (35.37%), 65 (44.21%), and 11 (07.48) patients, respectively [Figure 5].
Factors affecting financial toxicity
The univariate and multivariate regression analyses were performed to identify factors contributing to financial toxicity. On analysis, no intervariable correlation was observed. There was a combination of 5 variables that significantly correlated with the development of financial toxicity, F = 9.68 ( P < 0.001). These factors were age (beta = 0.242, P = 0.001), sex (beta = −0.119, P = 0.107), income (beta = 0.025, P = 0.798), hospital payment category (beta = 0.398, P = 0.000), and the presence of recurrent disease (beta = −0.151, P = 0.043) [Table 3]. The adjusted R2 value for factors leading to financial toxicity was 0.229. This indicates that 22.9% of the variance in the financial toxicity was explained by the model. According to Cohen's D (1988), this is a small effect.[8]
| Discussion | | |
In our study, the median FTS was 13 (Grade 2 severity) as per D'Rummo et al.'s grading scale,[7] which is considered severe financial distress. Age >60 years, the general payment category, and recurrent disease were significantly associated with low financial toxicity scores. i.e., higher financial distress. We used the FACT-Br scoring to analyze the QOL and found a statistically significant association between QOL and financial toxicity.
We carried out a PubMed search with the terms, “(Financial toxicity) AND brain tumor,” without any filters on April 20, 2020, and found a total of 59 articles. However, none of these articles addressed the issue of financial toxicity in patients with brain tumors undergoing systemic therapy. To the best of our knowledge, the current study is the first of its kind to report in this area of research. However, financial toxicity has been evaluated in various other malignancies. Rosenzweig et al. conducted a cross-sectional study and used the COST-FACIT for the analysis of financial toxicity in patients with metastatic breast cancer. The median FTS of the whole population was 23. It was 27 and 12.6 in the high- and low-income groups, respectively, indicating a significantly lower score in the latter. The investigators also reported that the COST score was associated with a poor QOL.[9] de Souza et al. also measured the financial toxicity and validated the COST-FACIT in patients with Stage IV solid malignancies. The median score was 23 and showed a significant association with income, QOL, and employment status.[6] D'Rummo et al. used the COST-FACIT in patients receiving radiation therapy and found a mean COST score of 21.86.[7] They also found a trend toward greater financial distress in patients younger than 65 years as well as unmarried patients; however, the difference was not statistically significant.
The COST-FACIT score assesses financial toxicity in patients with malignancies. As some items are reverse scored, lower values indicate a worse financial toxicity.[8] About 15% of the participants had COST scores of Grade 2 and 3 severity according to D'Rummo et al.'s scale, indicating severe financial distress.[9] In our study, 65 (44.2%) and 11 (7.5%) patients had Grade 2 and 3 financial toxicity, respectively.
According to the World Health Organization report, essential medicines are beyond the reach of or remotely accessible to around 68% of the Indian population, despite India ranking 4th and 13th when it comes to volumes and the value of pharmaceuticals produced worldwide.[9],[10] Moreover, in India, the noncommunicable diseases also have significant implications on the economy, as has been reported by a few studies. According to these studies, certain conditions such as cardiovascular diseases and cancer significantly add to the out-of-pocket (OOP) payment burden on the Indian households.[11],[12] It has been reported that 8% of the Indian households are pushed into poverty due to catastrophic health-care expenditure.[13] In nationwide consumer expenditure surveys, OOP expenditure for medicines was 4.49% of the total spending.[14] High OOP expenditure, lack of insurance, and low government expenditure create a vicious cycle leading to household impoverishment.[12]
We observed low scores for the COST-FACIT implying severe financial toxicity in our patients. This is of major clinical relevance as the low score reflected high financial toxicity that led to a detrimental effect on the QOL. Hence, the regular assessment of financial toxicity in these patients should be of the highest priority for early recognition and action to prevent QOL impairment. This burden can be handled with the help of various management strategies including government and institutional health schemes, social workers and nongovernmental organizations, and proper counseling and guidance. This approach should be incorporated into the supportive care offered to these patients.
Thus far, the existing literature lacks data on the financial toxicity incurred by Indian patients with brain tumors. Hence, we attempted to shed light on this issue in order to find its associated risk factors and their relative impact on the QOL. The strength of our study is that it is the first to present the financial toxicity data for a large homogeneous cohort of patients with brain tumors from the Indian subcontinent. The study is not without its limitations. First, the study captured the expectations and preferences at a single point in time because of its cross-sectional nature. Hence, it does not reflect the financial toxicity across the longitudinal course of the disease. Second, the study fails to assess whether the financial toxicity was related to OOP costs, loss of productivity, or other factors. Finally, no formal sample size calculation was done.
| Conclusions | | |
This is the first Indian study to report the perceived financial toxicity and QOL in patients with brain tumors and can be useful in generating hypothesis and sample size calculation for future studies. The FTS was lower in patients with brain tumors, implying higher financial toxicity. Various factors such as age, payment category under which the treatment was availed, and disease status were the major contributors. Low FTSs affect the QOL significantly, and regular assessment of financial toxicity is of the highest priority for the early recognition and action to prevent QOL impairment.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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| 11. | Selvaraj S, Farooqui HH, Karan A. Quantifying the financial burden of households' out-of-pocket payments on medicines in India: a repeated cross-sectional analysis of National Sample Survey data, 1994-2014. BMJ Open 2018;8:e018020 |
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]
[Table 1], [Table 2], [Table 3]
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