Translation and Validation of COST - FACIT (Version 2) Questionnaire into Hindi and Marathi to Assess Financial Toxicity in Indian Cancer Patients

Introduction

Cancer comes under one of the most expensive and exhaustive medical conditions.1 Treatment of cancer involves multiple treatment modalities, including surgery, radiation therapy, and systemic chemotherapy.1 During the course of the treatment, patients might get hospitalized for supportive care as well. Treatment cost along with supportive care cost further increases the financial toxicity of the patient. In low-middle income countries, patients undergoing cancer treatment often experience severe financial distress as a significant amount of their saving is spent on their ongoing treatment.2 Financial consequences of cancer treatment include significant out-of-pocket costs, loss of income, and caregiver burden.3

The term financial toxicity/stress refers to the various problems faced by the patients related to the cost of medical care. Financial toxicity has not only affected patients in cost-related issues but it also affects patients' quality of life and access to medical care. Such as, a patient may avoid visiting the hospital or may not take a medicine prescribed by the doctor, due to cost constraints. Due to the high cost associated with cancer treatment, cancer patients are at increased risk of financial toxicities.4

In the last two decades, major advances have been made in preventing, diagnosing, and treating various cancers with the use of newer targeted therapies, immunotherapies, and CAR-T cell therapies across multiple tumor types. This has not only led to improvement in the overall survival but also improvement in the quality of life of patients. However, all these advancements come at the increasing cost of the treatment. As the health cost increases, which leads to an increase in the financial burden, further resulting in higher out-of-pocket expenses.5

Patients and their family members bear the impact of rising healthcare expenditures. Although the new targeted therapies have proved to benefit from a medical point of view, it comes along with a high treatment cost leading to greater financial toxicity and increased financial distress, reduced quality of life, and subsequently poorer outcomes.6

Financial stress due to cancer is multifactorial. This includes the cost of cancer treatment consisting of chemotherapy, radiation, and surgery, travel cost to treatment centers. Moreover, there is a chance of temporary loss of productivity at work, or permanent termination from the job can be noticed in patients who are employed. All these factors add to the financial stress on the patient and also affects the quality of life of the patients.7

According to a new study from Virginia Commonwealth University, almost one-third of cancer survivors experience financial problems due to their diagnosis and/or treatment.8 Most of the patients especially the survivors, who have trouble paying the cost of the treatment are more likely to skip or delay medical care such as by delaying the prescriptions.1

Cancer survivors faces more financial problems which leads to further deterioration of their mental health-related quality of life.1

Financial stress has cancer-related psychosocial effects which are understudied and the degree to which cancer-related monetary costs affect an individual's overall quality of life has not been fully described.7

Nowadays, patient-reported outcome measures are becoming an integral part of the clinical trial outcome and also in the routine care of cancer patients. FACIT questionnaires are widely used as a measure to assess patient-reported outcomes.3 When it comes to assessing financial toxicity in patients, there is no such tool available to evaluate financial toxicity in patients, specifically in India. Comprehensive Score for financial Toxicity - Functional Assessment of Chronic Illness Therapy (COST - FACIT Version 2) is such a tool available in various languages but not in Hindi and Marathi. India, being a lower-middle-income country with a large population, has very low health-related insurance coverage. As a result, the majority of health-related expenses in India are Out of pocket (OOP) expenses. A study was conducted in north India on OOP expenses reported that the total mean expenditure was 10 times the per capita income and also, indirect costs were significantly higher than direct costs.9 Therefore, the current study was undertaken to translate the FACIT-COST questionnaire into Hindi and Marathi languages so that there will be a patient-reported outcome to assess the financial toxicity among the patients in our country.

Methods

Questionnaire

The COST - FACIT questionnaire consists of 12 questions (Fig. 1). It was developed by De Souza et al and was validated to assess the degree of financial stress experienced by patients with cancer.6 The COST questionnaire has 12 items that have been officially coded sequentially from FT1 to FT12. Items 2, 3, 4, 5, 8, 9, and 10 of the questionnaire are reverse scored. The responses vary from 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit), and 4 (very much). The score ranges between 0 and 44, and a higher score implies better financial well-being. 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) for the FACIT-COST.7

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Fig. 1: COST - FACIT questionnaire.

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The guidelines for the process of translation and validation were provided by the FACIT team. The steps included:

Results

Back Translations

The Hindi and Marathi reconciled questionnaires were then given to two translators for each Hindi and Marathi who did not know about the original COST - FACIT questionnaire in the English language. The translators were informed that the questionnaire is a tool to evaluate the financial toxicity in patients. They were requested to back translate the Hindi and Marathi questionnaires into the English language in simple and easily understandable language. For the Hindi version, the translator was NS. For the Marathi version, the translator was KA. The Hindi and Marathi back-translated questionnaires were then compared with the original English version of the questionnaire and were found to be similar.

The complete report was then sent to the FACIT team and after sorting out the comments raised by the FACIT team, the final questionnaires were considered to be used for pilot testing (Figs. 2 and 3).

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Fig. 2: COST - FACIT questionnaire (Hindi).

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Fig. 3: COST - FACIT questionnaire (Marathi).

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Pilot Testing

The approved Hindi and Marathi questionnaires were then distributed to 20 patients (10 each for Hindi and Marathi versions) who visited the Uro-Oncology department at our hospital and who had never seen the questionnaire before. The study population comprised participants who were native speakers of Hindi and Marathi, for the Hindi and Marathi versions, respectively. The median age of the entire cohort was 61 years (27–79). Nine out of the 20 participants (45%) had completed secondary school education, and 8 out of 20 (40%) had completed college and above education (Table 1).

Table 1

Baseline characteristics

Characteristics	Value
Age (y)
Range	27–79
Median	61
ECOG PS
0	3 (15)
1	17 (85)
Category
General	9 (45)
Private	11 (55)
Income
Range	500–800000
Median	23500
Diagnosis
Prostate cancer	12 (60)
Testicular cancer	4 (20)
Bladder cancer	2 (10)
Renal cell carcinoma	2 (10)
Education
Primary	1 (5)
Secondary	9 (45)
Technical	2 (10)
College and above	8 (40)
Metastatic
Yes	14(70)
No	6(30)

A correlation was observed between the monthly income of the patients and the COST score.

The mean COST score of 20 patients included in this study was 18.23 (range 4–33). Most of the patients, i.e., 45% experienced mild impact (Grade 1) financial toxicity, while 30% of the patients suffered moderate impact (Grade 2) financial toxicity (Fig. 4).

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Fig. 4: Patient distribution by FT grade; COST score ≥ 26 (Grade 0), 14–25 (Grade 1), 1–13 (Grade 2), and 0 (Grade 3).

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Discussion

Our study provides various desirable evidence to support the validity and reliability of the Hindi and Marathi versions of the FACIT-COST (version-2) to measure financial toxicity in cancer patients.

The guidelines provided by the FACIT team were adopted for translating and validating the FACIT-COST (version-2) questionnaire into Hindi and Marathi languages. The final translated questionnaires were then submitted to the FACIT team for their comments. A few queries were raised by the FACIT team, which were discussed by the investigators with the translators. The changes suggested by them were incorporated into the final questionnaires, which have now been approved by the FACIT team, some of them, such as FT2 in Hindi was initially translated as “Mere ilaaj ke liye mere jeb se hone wala kharch, mere anumaan se adhik hai” but after receiving comments by the FACIT team it was changed to “Mere ilaaj ke liye mere jeb se hone wala kharch, jitna maine socha tha usse adhik hai.” In Marathi FT2 was changed after comments from “Majhya vaidkiye kharch ha mee jitka vichar kela hota tyapeksha jast aahe” to “majha khishatun honara vaidkiye kharch ha mee jitka vichaar kela hota tyapeksha jast aahe,” also FT5 was modified from “mee nirash aahe ki mee kaam kru shakt naahi v majhe purn yogdaan deu shakt nahi” to from “mee nirash aahe ki mee kaahi kaam kru shakt naahi kiva je yogdan mee nehmi krto te kru shakt nahi.”

The Cronbach's α value for testing the reliability was 0.85 and 0.89 for Hindi and Marathi languages, respectively, indicating comparability to that of the original version.3 The value obtained was above 0.7, i.e., the reference value, which implied that the questionnaire had a high internal consistency and homogeneity. Also, high accuracy was observed in Hindi and Marathi languages.10

Financial toxicity is one of the most common issues faced by patients while undergoing cancer treatments.2 Most of the patients who were interviewed during the process of validation reported that the source of financial support for their cancer treatment was their personal savings or the financial support from the government in case they were government employees. In short term, the majority of the patients were able to manage the cost of the treatment but they expressed their concern for the long-term cost of their treatment as their savings will get depleted on long-term treatment.

Thus, there is a paucity of literature on the financial toxicity incurred by Indian patients. Some studies have been conducted in India that have indicated financial toxicity as one of the major problems amongst the cancer patients undergoing treatment that further affects the quality of life of patients. The majority of the studies, conducted in Indian patients, such as those by Wajid, Alexander, and Pati et al, used a self-constructed questionnaire to assess financial toxicity in patients.111213 Hence, there is a need for a validated tool in local languages to assess the financial toxicity in patients.

The translated questionnaire will help in assessing the financial toxicity that Indian patients encounter. The study had its limitations. The study included only a small section of the population (patients diagnosed with urological cancers of various stages). For a better understanding of the financial stress faced by the patients, a study can be planned in the future considering a large cohort of patients.

With the availability of translated and validated versions of the FACIT-COST questionnaire in Hindi and Marathi, financial toxicities associated can be assessed in patients undergoing cancer treatment and appropriate measures can be taken in the future to reduce this.

Conclusion

The questionnaire COST - FACIT (Version 2) has been approved and validated in Hindi and Marathi languages by the FACIT team and has been incorporated on their website (www.facit.org) for use in clinical practice and studies.