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Financial toxicity and mental well‐being of the oral cancer survivors residing in a developing country in the era of COVID 19 pandemic – A cross‐sectional study

Abstract Objectives The primary outcome measures evaluated the financial toxicity and mental well‐being of the oral cancer survivors. Methods A cross‐sectional study of oral cancer survivors who were disease‐free for more than 6 months after treatment and visited the hospital for a routine follow‐up is included in the study. Mental well‐being and financial toxicity were evaluated using the Depression, Anxiety, and Stress Scale ‐ 21 (DASS 21) and Comprehensive Score for financial Toxicity (COST‐ Functional Assessment of Chronic Illness Therapy) questionnaires. A literature review was done to compare the results with financial toxicity and mental health in cancer patients from the pre‐pandemic era. Results A total of 79 oral cancer survivors were included in the study, predominantly males (M: F = 10:1). The age ranged from 26 to 75 years (The median age is 49). The full‐time employment dropped from 83.5% in the pre‐treatment period to 21.5% post‐treatment. Depression was observed in 58.2% and anxiety in 72.2%. Unemployed survivors were observed to have more depression (OR = 1.3, 95% confidence interval (CI) = 0.3–5.4, p = 0.6), anxiety (OR = 3.5, 95% CI = 0.3–21.2, p = 0.1) and stress (OR = 1.6, 95% CI = 0.3–6.6, p = 0.5) than rest of the cohort. On univariate analysis, unemployed survivors (M = 11.8 ± 3.8, p = 0.01) had significantly poorer financial toxicity scores. Survivors with depression (M = 16.4 ± 7.1, p = 0.06) and stress (M = 14.4 ± 6.8, p = 0.002) had poor financial toxicity scores. On multifactorial analysis of variance, current employment (p = 0.04) and treatment modality (p = 0.05) were significant factors impacting the financial toxicity. Conclusion There is a trend towards increased incidence of depression, anxiety, and stress among oral cancer survivors compared to the literature from the pre‐COVID era. There is significant financial toxicity among either unemployed or part‐time workers. This calls for urgent public/government intervention to prevent the long‐term impact of financial toxicity on survival and quality of life.


| INTRODUCTION
The World Health Organization declared the novel coronavirus outbreak a public health emergency of international concern on 30 Jan 2020, and named the disease COVID-19 on 11 Feb 2020. 1 By the second week of September 2020, India had reported the highest number of COVID cases during the first wave. By May 2021, nearly two million confirmed cases had been reported. 2 The burden was unprecedented, and the health care system was not ready to handle it adequately. Cancer Care, in particular, was adversely affected. India. 3 The current pandemic has had a great deal of impact on society. In the wake of social distancing, lockdowns, virtual meetings, and consultations, a radically altered standard of living emerged and influenced multiple disciplines.
Most Head and Neck cancer (HNC) patients undergo multimodality treatment that can impact speech, swallowing, breathing, and bodily image. 4 Head and Neck cancer survivors are a particular group of people who require continued care in physical and psychosocial domains. 5 Psychological well-being is an essential aspect of survivorship care since a substantial percentage of HNC survivors (15%-50%) experience some depression at any given time. 6 As per Neilson et al., 30% of patients experienced anxiety before and 17% after the treatment. 7 Patients with cancer usually suffer from economic consequences due to high out-of-pocket (OOP) expenses and loss of income affected by the change in work. 8 In a developing country like India, where medical insurance is not popular, most people seek health care at public sector institutions with high OOP expenditure.
An Indian study by Chauhan et al. reported that 93% of patients with HNC seeking treatment at their institute had a per capita income of < ₹ 10,000/year. 9 Poor financial status impedes quality health care and quality of life; further adding to the woes is the recent pandemic among cancer survivors. To the best of our knowledge, there is a lacuna in the scientific literature comparing the mental health and financial well-being of oral cancer survivors in relation to the COVID pandemic. The article aims at studying the mental well-being and financial toxicity using the Depression, Anxiety, and Stress Scale -21 Items (DASS 21) and Comprehensive Score for financial Toxicity (COST) -Functional Assessment of Chronic Illness Therapy (FACIT) questionnaires in the COVID 19 pandemic era.

| Design and settings
The present cross-sectional study was conducted in a tertiary care hospital in a sub-Himalayan city in North India. The study included all the post-treatment disease-free oral cancer survivors (for more than six months) that visited the hospital for routine follow-up from May 2020 to October 2021.

| Measures
Primary outcome measures were mental health and financial toxicity.
Patients diagnosed or treated for second primary or recurrent disease and non-consenting patients were excluded from the study.
After recording the demographic and clinical details, participants were asked to answer the DASS 21 and COST -FACIT questionnaires following all the COVID precautions. Informed consent was obtained from all the study participants. The current research has been approved by the institutional ethics committee and registered with the Clinical Trials Registry -India (CTRI/2020/07/026848).

| Literature search stratergy for comparison of mental health and financial toxicity
We conducted a literature search in PubMed for articles published between 1 January 2000, and 1 October 2021. First, the following key terms were used: Oral cancer, HNC, cancer, mental health, Depression, anxiety and stress, and financial toxicity with COST FACIT scores. Then, some of these terms were used in combination for the search. Finally, a result was manually checked for relevant pre-pandemic era data studies. Both prospective and retrospective cohort studies that evaluated Depression, anxiety, stress and financial toxicity were considered to compare our study results.

| Analysis
Statistical analysis was done using Statistical Package for Social Sciences 26 software. Numerical uniform and non-uniform data are presented as mean � standard deviation and median � interquartile range. Categorical data is entered as percentages. For parametric data, one-way Analysis of variance (ANOVA) is used for the singlefactor analysis of variance and multi ANOVA for the multi-factor variance of analysis. For analysis of DASS 21 results, final depression, anxiety and stress are represented as binary data (Yes/No), and Logistic regression is used to describe the relationship between depression, anxiety, stress and other independent variables. A Pearson product-moment correlation was run to determine the relationship between DASS 21 scores and COST FACIT scores. Table 1 shows the demographic and clinical details of the survivors.

| RESULTS
Seventy-nine patients were included in the study, predominantly males (10:1). The age ranged from 26 to 75 years (The median age is 49). It was noted that the majority (60.7%) of tumours were located in the buccoalveolar complex. Most patients (74%) presented with advanced-stage disease. Therefore, it is understandable (81%) that the majority required multimodality treatment. It is an interesting observation that post-treatment employment (21.5%) decreased drastically compared to pre-treatment employment (83.5%). Table 2 illustrates the depression, anxiety, and stress levels among the survivors in detail. It was observed that more than half of the study cohort had depression (58.2%) and anxiety (72.2%). Supplementary Table 1 Table 4 illustrates the mental well-being and financial toxicity of studies from the pre-pandemic era. Depression rates ranged from 17% to 65%, Anxiety rates ranged from 20% to 35%. [14][15][16] Our study shows depression among 58.2% and anxiety in 72.2%. Mean financial toxicity scores (COST FACIT) among cancer patients varied from (M = 20.18-21.9). [25][26][27] Our study cohort has Mean COST scores of (M = 17.9 � 8.4).

| DISCUSSION
The present generation has not witnessed such a large scale catastrophe as this COVID 19 Pandemic. COVID 19 has affected almost every facet of life, including physical health and social and family life.
In particular, cancer patients are a vulnerable group who require special attention during and after the treatment. There is a significant compromise in the care of cancer patients during the pandemic.

Tevetoğlu et al. observed a significant delay in diagnosis and treatment
initiation; they also observed that most patients were presented in an advanced stage than the historical data. 10 Chen et al. reported that almost 50% of the patients had treatment interruptions during the pandemic. 11 There was a delay in follow up for 58% of patients and cancer-related complications in almost 68% of patients during the pandemic, as observed by Claudine et al. 12 Mental well-being is an essential domain among cancer survivors, and the recent pandemic has impacted the mental well-being of cancer survivors. Incidence rates of worse mental health are higher among cancer patients than in the general population. 5 It is essential to address the psychosocial impact of the pandemic on cancer survivors. A cross-sectional study was conducted to evaluate the toll of the current pandemic on mental health and financial toxicity in oral cancer survivors.
Notably, more than half of our study cohort suffered from depression and anxiety. Financial toxicity may differ based on the population's economic, cultural, and sociodemographic conditions. However, the financial toxicity scores were worse in studies published in the COVID era compared to the data published pre-COVID period. Current study scores indicate more significant financial toxicity in the cohort than those published from other Asian countries (Table 4).
In the current study cohort, 47% of the full-time workers  36 Most studies report that financial toxicity/distress and mental well-being are interrelated.

| Clinical implications
The COVID-19 pandemic has impacted cancer care globally and more severely the developing countries. From the perspective of a We concede that another major limitation of the study is the sample size. Large sample size would give more accurate results and less margin of error. Though our cancer clinic handles a considerable load of oral cancer patients nevertheless poor follow-up is also a known fact in most of the public-funded cancer centres of our country due to various socio-cultural, geographic and financial factors. Adding to the woes is the pandemic; there is a significant reduction in the registrations of patients at the oncology clinics.
Another important consideration is that, may be poor follow up is related to increased financial toxicity and poor mental health of the survivors, necessitating future studies with more extensive, representative samples and longitudinal data to generalize the results.

| CONCLUSION
There is a trend toward increased incidence of depression, anxiety, and stress among oral cancer survivors compared to the literature from the pre-COVID era. There is significant financial toxicity among either unemployed or part-time workers. This calls for an urgent public/government intervention to prevent the long-term impact of financial toxicity on survival and quality of life.