Keywords
cancer - COST FACIT - financial toxicity - translation - validation
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
Study Design
The study is a single-center, cross-sectional study, conducted in the Department of
Uro- Oncology at the Tata Memorial Hospital, a tertiary cancer center in Mumbai, India.
The original version of the COST - FACIT (Version 2) was translated from English into
Hindi and Marathi languages, following the FACIT translation guidelines and was also
tested for content validity.
Formal permission for using a FACIT questionnaire from the FACIT Measurement System
Web site (http://www.facit.org) was taken for developing the Hindi and Marathi versions of the FACIT-COST through
iterative forward–backward translation sequences.
After taking permission from the FACIT, ethical approval was obtained from the Institutional
Ethics Committee of the Tata Memorial Hospital on February 27, 2020. The trial was
registered on the Clinical Trial Registry of India (http://ctri.nic.in) on June 9, 2020.
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]
Fig. 1 COST - FACIT questionnaire.
The guidelines for the process of translation and validation were provided by the
FACIT team. The steps included:
Forward Translation
The English COST - FACIT questionnaire was translated into Hindi and Marathi languages,
as appropriate, as possible to the original English COST - FACIT (Version 2) by two
translators, who were fluent in the target languages, i.e., Hindi or Marathi and English.
Reconciliation
The two forward translations were reconciled by a third translator, who was fluent
in both Hindi or Marathi and English Language.
Back Translation
The reconciled version of the questionnaire was then back-translated to English by
a translator, fluent in English and the native language (Hindi or Marathi).
All translations were then sent to the FACIT team for review. A few comments raised
by the FACIT representative were resolved and the final questionnaire in Hindi and
Marathi languages was then tested among the population.
Pilot Testing and Study Population
After getting the questionnaire approved by the FACIT team, the Hindi and Marathi
questionnaires were then administered to 20 patients (10 each for Hindi and Marathi
versions) who visited the Uro-Oncology department at our hospital and were reading
the questionnaire for the first time. Participants included in this study were patients
who were fluent in Hindi and Marathi for the Hindi and Marathi versions, respectively.
Statistics
Demographic analysis was performed for age, education, performance status, income,
and category of the patients (general or private as per the hospital policy). A correlation
was performed using Pearson's test for correlation using IBM SPSS Statistics for Windows,
Version 22.0 IBM Corp Armonk.
Results
Forward Translations (Hindi and Marathi)
The English COST - FACIT questionnaire was given to two translators for translating
it into Hindi and Marathi languages. For Hindi translation, translators I and II were
SA and DV, respectively. Both the translators had a good command of English and Hindi.
For the Marathi version, translator I was RB, and translator II was DB.
Difficulties Encountered During Translations
The Hindi and Marathi questionnaires were then evaluated by one of the investigators
of the study. No significant differences were found between the two forward Hindi
and Marathi questionnaires prepared by the translators. Both Hindi and Marathi forward
translations were finalized after a round of due discussion between the translators
and investigators.
Reconciliation
The Hindi and Marathi forward translations were reconciled into a single questionnaire
by SD and PD, respectively, after due discussions with one of the investigators of
the study.
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]).
Fig. 2 COST - FACIT questionnaire (Hindi).
Fig. 3 COST - FACIT questionnaire (Marathi).
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]).
Fig. 4 Patient distribution by FT grade; COST score ≥ 26 (Grade 0), 14–25 (Grade 1), 1–13
(Grade 2), and 0 (Grade 3).
Reliability Analysis
The questionnaires demonstrated good content and high internal consistency (Cronbach's
α: 0.85 for Hindi, 0.89 for Marathi) ([Tables 2] and [3]).
Table 2
Cronbach's reliability test for Hindi
|
Question
|
Mean
|
Std. deviation
|
Cronbach's alpha
|
|
FT1
|
1.67
|
1.414
|
0.823
|
|
FT2
|
1.56
|
1.509
|
0.823
|
|
FT3
|
0.67
|
1.414
|
0.818
|
|
FT4
|
0.67
|
1.323
|
0.859
|
|
FT5
|
1.56
|
1.509
|
0.834
|
|
FT6
|
1.67
|
1.323
|
0.811
|
|
FT7
|
1.78
|
1.202
|
0.815
|
|
FT8
|
1.89
|
1.453
|
0.826
|
|
FT9
|
2.44
|
1.424
|
0.848
|
|
FT10
|
1.22
|
1.481
|
0.824
|
|
FT11
|
1.33
|
1
|
0.829
|
|
FT12
|
2.56
|
1.59
|
0.927
|
Table 3
Cronbach's reliability test for Marathi
|
Question
|
Mean
|
Std. deviation
|
Cronbach's alpha
|
|
FT1
|
1.6
|
0.966
|
0.885
|
|
FT2
|
1.4
|
1.578
|
0.894
|
|
FT3
|
1
|
1.155
|
0.877
|
|
FT4
|
0.8
|
1.033
|
0.894
|
|
FT5
|
2.4
|
1.578
|
0.888
|
|
FT6
|
1.5
|
1.08
|
0.877
|
|
FT7
|
1.4
|
1.265
|
0.876
|
|
FT8
|
1.3
|
1.418
|
0.894
|
|
FT9
|
1.8
|
1.619
|
0.875
|
|
FT10
|
1.3
|
1.16
|
0.875
|
|
FT11
|
1.6
|
1.506
|
0.874
|
|
FT12
|
3.4
|
0.966
|
0.936
|
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.[11]
[12]
[13] 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.
