Impact of cancer diagnosis on use of smokeless tobacco: A descriptive study of patient-relative dyads.

Background: The time of cancer diagnosis is considered as a teaching moment with regard to tobacco cessation. Aim: In view of the limited studies focussing on smokeless tobacco (SLT), we aimed to assess the patterns of SLT use, attitudes toward SLT use in the context of cancer diagnosis, and factors associated with quitting SLT in dyads consisting newly diagnosed patients with head and neck cancers and their relatives. Material and Method: A total of 106 such dyads were assessed on cross-sectional study design. The patients included in the study were above 18 years of age of either sex with a recent (i.e., <6 months) diagnosis of head and neck (lip, tongue, mouth, oropharynx, hypopharynx, pharynx, and larynx) cancer (HNC), not having undergone any surgical intervention for the same and having used SLT for at least 6 months continuously prior to diagnosis of HNC. For each patient, one family member who was aged 18 years or above and lived for at least past 1 year with the patient was included. Result: We found that 60.4% of patients and 6.53% of relatives quit SLT use after the diagnosis of cancer. However, motivation to quit was greater despite continued SLT use, in both patients and relatives. Reasonable number of patients and relatives reported awareness regarding health warnings and long-term consequences of SLT use on cancer. For patients, use of only one form of SLT, presence of 2 or more males in the family using SLT, and presence of another tobacco-related medical disorder in the family were significantly higher in those who quit.
Conclusion: The diagnosis of cancer might indeed act as a "teaching moment" for many users but this effect is not extendable on to their relatives. Copyright:

INTRODUCTION

There is an intricate relationship between cancer and tobacco use. Tobacco use remains a major causative but preventable factor for cancer. Cancer rates reported to be related to tobacco use are significant (45.7% in males and 16.5% in females).[1] Specifically, more than 40% of head and neck cancers (HNC: lip, tongue, mouth, oropharynx, hypopharynx, pharynx, and larynx), in both men and women, have been attributed to use of smokeless tobacco (SLT),[2] which is much greater than tobacco smoking in India.[3]

In terms of tobacco cessation, the time of cancer diagnosis is crucial. A diagnosis of cancer personalizes harms of tobacco use and prioritizes urgent restoration and maintenance of good health for patients and their family members using tobacco. Pertinently, it has been considered a “teachable moment” for patients and their relatives.[4] Majority of literature studying this context though has been focussed solely to tobacco smoking.

Our primary aim was to study the change in patterns of SLT use after the diagnosis of cancer and knowledge and attitudes toward SLT use in the context of cancer diagnosis in newly diagnosed patients with head and neck cancers and their relatives. Secondarily, we aimed to analyze factors associated with quitting SLT in them.

METHODS

This paper reports results of the first phase of the BITDOC study (Approved by Institutional ethics committee (Ref: 569/IEC-AIIMSRPR/2019, dated).[5] This cross-sectional study was conducted at a tertiary care medical institute from central India between 20/02/2019 and 22/02/2020. The study sample was drawn from the outpatient clinic/inpatient ward of the Department of ENT and Head and Neck Surgery, which has an average outpatient attendance of 150 patients of which about 30 are patients with head and neck cancers. The facility, a central government funded autonomous institute, has premier facilities for treatment of cancers—surgical, medical, as well as radiotherapy. The assessments for the study were conducted at the Department of Psychiatry.

The patients included in study were purposively sampled. The inclusion criteria required them to be above 18 years of age of either sex with a recent (i.e., <6months) diagnosis of head and neck (lip, tongue, mouth, oropharynx, hypopharynx, pharynx, and larynx) cancer (HNC), not having undergone any surgical intervention for the same and having used SLT for at least 6 months continuously prior to diagnosis of HNC. Patients who smoked tobacco, currently pregnant, or with past history of any cancer were excluded from the study. For each patient, one family member who was aged 18 years or above and lived for at least past 1 year with the patient was included. Family members having any severe psychiatric illness, history of cancer/precancerous lesion, or currently pregnant were also excluded from study. A total of 136 patients were screened of which patient-relative dyads were available for 112; data from 6 dyads couldn’t be collected due to feasibility reasons—lack of time, unable to converse due to effects of cancer, emergency appointments, etc. Data from a total of 106 patient-relative dyads were collected. Due to incomplete responses, data of 2 relatives were excluded. Therefore, data from 106 patients and 104 relatives were analyzed.

A custom made, study specific questionnaire proforma that included items assessing pattern and amount of SLT use, change in attitudes and behaviors (substance, physical exercise, food habits, lifestyle, etc.) toward cancer prevention and screening, and, attitude toward health warnings, and long-term consequences with SLT use related to cancer progression and management was prepared. The proforma was based on variables assessed across various relevant studies and other specific domains identified in the literature review.[34678] While dependence syndrome among the participants was evaluated using the ICD-10 DCR criteria,[9] modified Fagerström test for nicotine dependence was used to assess for severity of dependence.[10] The pre and post-diagnosis pattern and amount of SLT use were noted cross-sectionally, that is, at a single time-point (after the diagnosis). When assessed retrospectively, the Fagerström test for nicotine dependence has been shown to have acceptable reliability.[11]

Tumour staging (0–IV) was done based on the American Joint Committee on Cancer staging classification system.[12] The Adult Comorbidity Evaluation-27[13] and the Hindi translation of the Oral Health Impact Profile[14] were used to assess comorbidities, if any, and oral health dysfunction.

All study-related information was captured and stored on a handheld device (android tablet) after obtaining informed consent from the participants.

Statistical analysis

Frequencies and descriptive statistics were calculated. Intra-dyad correlation was measured using intraclass correlation coefficient (ICC). Independent samples t or Pearson χ2 tests were used for comparing study independent variables (all the socio-demographic and clinical variables) between current SLT users and those who quit. The third quartile scores of certain continuous variables (number of family members and the number of them using SLT) were taken as the cut off for binomially categorizing the groups.

RESULTS

The sociodemographic details of the study population has been summarized in Table 1. We observed that relatives had lesser mean age and relatively greater number of them were unmarried and had better education status. Table 1 also shows characteristics of the number of family members and the number of them using SLT. It also shows that 8.5% and 3.8% of the dyads have family history of cancer and other medical disorders related to tobacco (breathing difficulties (n = 2), heart problems including myocardial infarction (n = 1), chewing difficulties (n = 1)), respectively.

Table 1

Comparison of sociodemographic variables across the groups

Variable	Patients Mean±SD/n (n%)/median; Q3 (n=106)	Relatives Mean±SD/n (n%) / median; Q3 (n=104)
Age (in years)	46.83±12.63	34.13±10.37
Gender
Male	83 (78.3%)	80 (76.9%)
Female	23 (21.7%)	24 (23.1%)
Marital Status
Married	87 (82.1%)	76 (73.1%)
Unmarried	6 (5.7%)	27 (26.0%)
Widowed	13 (12.3%)	1 (1.0%)
Religion
Hindu	102 (96.2%)	101 (97.1%)
Muslim	3 (2.8%)	2 (1.9%)
Christian	2 (1.9%)	1 (0.9%)
Education Status
Illiterate	35 (33.0%)	8 (7.7%)
Primary	31 (29.2%)	20 (19.2%)
Secondary	32 (30.2%)	49 (47.1%)
Graduation	6 (5.7%)	19 (18.3%)
PG	2 (1.9%)	8 (7.7%)
Employment Status
Employed	91 (85.8%)	86 (82.7%)
Unemployed	15 (14.2%)	18 (17.3%)
Socio-economic status
Lower	93 (87.7%)	86 (82.7%)
Middle	10 (9.4%)	18 (17.3%)
Higher	3 (2.8%)	0 (0.0%)
Habitat
Rural	80 (75.5%)	76 (73.1%)
Suburban	4 (3.8%)	5 (4.8%)
Urban	22 (20.8%)	23 (22.1%)
Income (in Rupees per month)	7067±8677.75	8094.59±11760.94
Number of family members
Total	6 (median); 7 (Q3)
Adults (males)	2 (median); 3 (Q3)
Adults (females)	2 (median); 3 (Q3)
Children	2 (median); 3 (Q3)
Number of family members using SLT
Total	2 (median); 2 (Q3)
Males	1 (median); 2 (Q3)
Females	2 (median); 1 (Q3)
Positive Family history of Cancer	8 (8.5%)
Positive Family history of other medical diseases related to tobacco	4 (3.8%)

Q3=Third quartile

Table 2 shows characteristics of SLT use before the diagnosis of cancer in patient and relatives. Out of 106 relatives, 46 were SLT users. The mean age of onset of SLT use was in early twenties in both the groups. While 100% of patients and 91.3% of relatives were daily SLT users before the cancer diagnosis, age of onset of daily use was again in early twenties. While majority of patients and relatives used one form of SLT, use of 2 or more forms was greater in patients. More than 90% of the patients and about 57% of relatives were using SLT in dependence pattern; duration of dependence was approximately 15 years and 9 years in patients and relatives, respectively. The mean scores on the modified Fagerström test for both patients and relatives were approximately around 5. While 46.2% and 26.1% of patients and relatives attempted to stop SLT use, the mean numbers of attempts were 1.67 in patients and 2.04 in relatives. During these attempts, the mean total duration of abstinence was about 100 days in both the groups.

Table 2

Characteristics of SLT use in study population before the diagnosis of cancer

Variable	Patient Mean±SD/n (n%) (n=106)	Relatives Mean±SD/n (n%) (n=46)
Age of onset of SLT use (in years)	21.29Total duration of abstinence (in days)9.81	20.28±6.06
Freq. of tobacco use
Daily	106 (100%)	42 (91.3%)
Less than daily	0 (0.0%)	2 (4.3%)
Occasionally	0 (0.0%)	2 (4.3%)
Age of daily use (in years)	22.85±10.03 (n=106)	21.41±6.09 (n=42)
Type of SLT use
Only Khaini	16 (15.1%)	2 (4.4%)
Only Guthka	16 (15.1%)	20 (44.4%)
Only Gudaku	16 (15.1%)	8 (17.8%)
Only Pan	1 (0.9%)	1 (2.2%)
Khaini + Ghutka	8 (7.5%)	3 (6.7%)
Khaini + Pan	3 (2.8%)	0 (0.0%)
Khaini + Gudaku	11 (10.4%)	3 (6.7%)
Gudaku + Ghutka	13 (12.3%)	3 (6.7%)
Gudaku + Pan	1 (0.9%)	0 (0.0%)
Khaini + Ghutka + Gudaku	12 (11.3%)	3 (6.7%)
Khaini + Ghutka + Pan	2 (0.9%)	0 (0.0%)
Khaini + Gudaku + Pan	1 (0.9%)	0 (0.0%)
Khaini + Ghutka + Naswar	1 (0.9%)	0 (0.0%)
Khaini + Ghutka + Gudaku + Pan	4 (3.8%)	2 (4.4%)
Khaini + Naswar + Pan	1 (0.9%)	0 (0.0%)
1 Types of SLT	49 (46.2%)	52 (69.6%)
2 Types of SLT	36 (34.0%)	9 (19.6%)
3 Types of SLT	17 (16.0%)	3 (6.5%)
4 Types of SLT	4 (3.8%)	2 (4.3%%)
Dependence pattern
Yes	96 (90.6%)	31 (67.4%)
No	10 (9.4%)	15 (32.6%)
Duration of dependence (in years)	14.76±12.18 (n=96)	9.33±8.88 (n=31)
Modified Fagerström test score	4.26±2.12	5.40±2.80
Attempt to stop SLT
No	57 (53.8%)	34 (73.9%)
Yes	49 (46.2%)	12 (26.1%)
Number of attempts	1.67±3.16 (n=49)	2.04±2.46 (n=12)
Total duration of abstinence (in days)	113.87±324.80 (n=49)	100.31±291.76 (n=12)

Table 3 shows characteristics of cancer; site and stage of carcinoma in majority of patients was oral activity and stage III/Iva, respectively. While 62 patients and 44 relatives were using another substance apart from tobacco, alcohol use was predominant in both the groups. Dependence for other substances could be established in 35.5% of patients and 11.4% of relatives [see Table 4].

Table 3

Characteristics of cancer diagnosis

Variables	n (%)/Mean±SD
Site of Carcinoma
Oral cavity n(%)	102 (96.2)
Oropharynx n(%)	2 (1.9)
Hypopharynx n(%)	2 (1.9)
TNM staging of cancer
Stage I	9 (7.5)
Stage II	11 (10.4)
Stage III	28 (26.4)
Stage IVa	56 (52.8)
Stage IVb	2 (1.9)
Duration since Cancer Diagnosis (Mean ± SD) (In days)	64.30±69.12

Table 4

Characteristics of other substance use in study population

Variable	Patient	Relatives
	Mean±SD/n (n%) (n=62)	Mean±SD/n (n%) (n=44)
Alcohol only	60	43
Cannabis only	1	1
Alcohol + Cannabis	1	0
Pattern of usage
Daily	17 (27.4%)	4 (9.0%)
Less than daily	7 (11.3%)	3 (6.8%)
Occasionally	38 (61.3%)	37 (84.1%)
Duration	16.16±11.59	10.35±8.58
Dependence	22 (35.5%)	5 (11.4%)

Although 86.8% patients and 34.8% of relatives reported to have attempted quit SLT use, only 60.4% of patients and 6.53% of relatives were maintaining abstinence at the time of assessment. Table 5 shows SLT profile in patients and relatives post cancer diagnosis. Among those who continued using SLT, the frequency of daily users was lower in patients (25.5%) compared with relatives (84.8%). The mean scores on the modified Fagerström test marginally reduced from their pre-diagnosis scores in patients who continued to use SLT, but not in relatives. The intra-dyad ICC was poor (i.e., 0.03). However, more than 80% of both patients and relatives stated that they will quit in 1 months’ time. While 85.8% of patients were advised to stop SLT by a doctor after the diagnosis of cancer, only 10.9% of relatives were advised so. The number of patients and relatives who tried counseling, nicotine replacement, other prescription, or traditional methods to quit SLT use were very small.

Table 5

Post cancer SLT use profile

Variable	Patients Mean±SD/n (n%) (n=106)	Relatives Mean±SD/n (n%) (n=46)*
Current use of SLT
No	64 (60.4%)	3 (6.53%)
Yes	42 (39.6%)	43 (93.47%)
Freq of SLT use after diagnosis
Daily	27 (25.5%)	39 (84.8%)
Less than daily	9 (8.5%)	2 (4.3%)
Occasionally	6 (5.7%)	2 (4.3%)
Never	64 (60.4%)	3 (6.6%)
Modified Fagerström test score
Pre diagnosis	5.26±2.29 (n=42)	5.32±2.65 (n=43)
Post diagnosis	3.88±1.83 (n=42)	5.14±2.65 (n=43)
Attempted to stop SLT after diagnosis
Yes	92 (86.8%)	16 (34.8%)
No	14 (13.2%)	30 (65.2%)
What describes best about SLT use in current users (Patients (n=42); relatives (n=43))
Will Quit in 1 month	37 (88.9%)	35 (81.8%)
Will Quit in 12 months	4 (8.9%)	5 (11.4%)
Not interested in quitting	1 (2.2%)	3 (6.8%)
Duration of abstinence after diagnosis (in days)	43.81±46.73	5.41±15.05
Was adviced to stop SLT in doctor visit for patient
Yes	91 (85.8%)	5 (10.9%)
Tried Counselling to stop SLT
Yes	3 (2.8%)	1 (1.0%)
Tried Nicotine therapy to stop SLT
Yes	2 (1.9%)	2 (1.9%)
Tried Other prescription medicines
Yes	4 (3.8%)	0 (0.0%)
Tried Traditional Medications
Yes	9 (8.5%)	0 (0.0%)

*Out of 104 relatives, 46 of them were using SLT

See Table 6 for frequency of patients and relatives with various attitudes toward health warnings and long-term consequences of SLT use on cancer and its treatment. While more than 95% of relatives noticed the health warning appearing on tobacco packaging and information on the television, newspaper, or magazine, 11.3% of patients reported not noticing or hearing them. Majority of both patients and relatives found the warnings effective and led them to think about or attempting to quit or seek help to quit. While >98% of both patients and relatives felt the need to quit SLT use after a diagnosis of cancer and within 3 months of it. The knowledge about worsening of cancer, causation of cancer in other parts of the body, interference with cancer treatment, and leading to early death and aggravation of psychiatric comorbidities, due to continued SLT use was lower in patients compared with relatives. Table 7 shows change in health behavior following cancer diagnosis and oral health and comorbidity profile.

Table 6

Attitude toward health warnings and long-term consequences of SLT use on cancer and its treatment

Variable	Patients n(%) (n=106)	Relatives n(%) (n=104)
Health Warnings
Notice health warnings on product
No	12 (11.3%)	1 (1.0%)
Yes	94 (88.7%)	103 (99.0%)
Information in TV, newspaper, magazine
No	12 (11.3%)	2 (1.9%)
Yes	94 (88.7%)	102 (98.1%)
Information heard on radio, TV
No	12 (11.3%)	4 (3.8%)
Yes	94 (88.7%)	100 (96.2%)
Find health warnings effective
No	47 (44.3%)	31 (29.8%)
Yes	59 (55.7%)	73 (70.2%)
Warning lead to think about quitting
No	59 (55.7%)	75 (72.1%)
Yes	47 (44.3%)	29 (27.9%)
Warning lead to Attempt/seek help to quit
No	68 (64.2%)	82 (78.8%)
Yes	38(35.8%)	22 (21.2%)
Long-term consequences
Need to quit after cancer diagnosis
No	0	1 (1.0)
Yes	106 (100%)	103 (99.0%)
When to quit after diagnosis
Immediately	97 (91.5%)	98 (94.5%)
Within 3 months	9 (8.5%)	4 (3.8%)
After 6 months	0 (0.0%)	2 (1.9%)
Can continued SLT intake worsen cancer
No	9 (8.5%)	1 (1.0%)
Yes	97 (91.5%)	103 (99.0%)
Can SLT intake cause cancer in other body parts
No	17 (16.0%)	10 (9.6%)
Yes	89 (84.0%)	94 (90.4%)
SLT interfere in treatment
No	17 (16.0%)	2 (1.9%)
Yes	89 (84.0%)	102 (98.1%)
Continued SLT intake cause earlier death
No	18 (17.0%)	11 (10.6%)
Yes	88 (83.0%)	93 (89.4%)
SLT intake aggravate psychiatric comorbidities
No	22 (20.8%)	7 (6.7%)
Yes	84 (79.2%)	97 (93.3%)
Risk in quitting SLT
No	98 (92.5%)	94 (90.4%)
Yes	8 (7.5%)	10 (9.6%)
Risk of quitting SLT outweigh benefits
No	89 (84.0%)	88 (84.6%)
Yes	17 (16.0%)	16 (15.4%)

Table 7

Change in health behavior following cancer diagnosis and oral health and comorbidity profile

Variable	Patients n(%)/Mean±SD (n=106)	Relatives n(%)/Mean±SD (n=106)
Change in health behavior after diagnosis
Yes	23 (21.7%)	18 (17.3%)
Change in eating/food habit
Increased consumption of vegetables and fruits	7 (6.6%)	10 (9.6%)
Increased consumption of dairy products	2 (1.9%)	0 (0.0%)
Decreased intake of red meat	1 (0.9%)	2 (1.9%)
Decreased spice consumption	5 (4.7%)	3 (2.9%)
Change in exercise habit
Started exercising	1 (0.9%)	3 (2.9%)
Decreased exercising	1 (0.9%)	0 (0.0%)
Oral health impact profile-14
Functional Limitation	5.09±2.62	2.23±0.88
Physical Pain	5.83±2.64	2.17±0.57
Psychological Discomfort	5.46±2.61	2.20±0.72
Physical Disability	4.99±2.66	2.13±0.67
Psychological Disability	5.23±2.65	2.15±0.66
Social Disability	4.19±2.30	2.07±0.45
Handicap	4.52±3.09	2.05±0.40
Adult Comorbidity Evaluation
None	85 (80.2%)	96 (92.3%)
Mild	19 (17.9%)	8 (7.7%)
Moderate	2 (1.9%)	0 (0.0%)

On comparing patients who continued and quit SLT use after a diagnosis of cancer, on various independent variables, frequency of 2 or more males in the family using SLT (χ2 = 12.520; P =0.008), presence of family history of another tobacco-related medical disorder (χ2 = 6.334; P =0.023), and only one type of SLT (χ2 = 9.041; P =.021) were higher in those who quit SLT use. As majority (93.5) of relatives who used SLT before continued to use even after the cancer diagnosis, this analysis was not done in them.

DISCUSSION

This study is first of its kind from India that focusses on factors influencing continued SLT use in patients with cancers. Our main results show that although daily usage and severity may reduce, about 40% of patients continue using SLT despite the diagnosis of cancer. These rates are similar to previous reports,[4] specifically from India.[15] The encouraging fact is that >85% of patients have attempted to quit after the diagnosis and show willingness to quit in near future. Although advised routinely in cancer clinics to quit SLT use, a more formal and structured SLT cessation sessions might help them better. Ignorance to health warnings, lack of sufficient knowledge about long-term consequences of SLT use on cancer and its treatment, and recommended lifestyle modifications might be dealt in such sessions. Like elsewhere, cancer care in India too should include tobacco cessation program and specific emphasis to SLT should be given where appropriate.[16] Being specific to SLT may be more helpful to regions like that of the state of Chhattisgarh (where the present study has been conducted), where the prevalence of tobacco use (29.86%) is way above the national prevalence (20.89%) (National Mental Health Survey, 2016).[17]

We found that in those patients who could quit SLT had more men in the household who used SLT. This is in contrary to the findings from the west which suggests presence of tobacco users in family and social contacts as barriers to quitting tobacco.[4] This implicates the role of moral value systems and “shame culture” within Indian families. Presence of tobacco-related other medical disorders in the family is identified as another factor in those who quit successfully in our study also might signify the same. Previous studies suggest that severity of nicotine dependence is also a barrier for quitting.[4] Although, there was no association with severity scores in our patient sample, using 2 or more forms of SLT was associated with continued use. Therefore, assessment of number of types used might have a distinction for assessing SLT severity. Mathew et al. (2020),[15] a recent study from India, qualitatively identified factors associated with quitting successfully and continued use in patients with HNC. While perceived benefits of quitting and advice from the physicians were reported as reasons to quit, poor coping and nihilistic attitude regarding cancer outcomes were reported as reasons for continues use; awareness about cancer and its association with tobacco and a lack of it were positively and negatively associated with quitting. Quantitatively, however, we were unable to replicate most of these associations.

The rates of continued SLT use despite diagnosis of cancer in their kin is more staggering (93.47%) for patients’ relatives, in whom the pattern and severity of SLT use remains mostly unchanged. The attempt to change in them also has been meagre and the intra-dyad conformity too was poor. This result suggests that the diagnosis of cancer as a “teaching moment” may not extend to patients’ relatives, especially in Indian settings. A previous study, however, reported a contrasting notion.[18] Our finding calls for the inclusion of patient–relatives-dyads in the tobacco cessation programs. During medical consultation, intriguingly, only 5% of relatives were advised SLT cessation implying a missed window of opportunity to advice relatives to quit SLT use.

Further, our study results imply that all clinicians dealing with various cancers due to use of tobacco in various levels of healthcare system must assess for tobacco use comprehensively and continue to assess them during all the phases of cancer management. Studies must be conducted to understand various factors that might lead to persistent use of SLT despite the diagnosis of cancer or other serious medical health disorders that were directly linked to the SLT use. Various forms of interventional strategies to reduce SLT use should be studied for comparative efficacy. The emphasis on tobacco cessation is limited only for the universal prevention of cancers in the National Cancer Control Programme, the National Tobacco Control Programme, and the National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases, and Stroke. Our study results imply that the prevention strategies suggested in these programmes must be extended to include the following: (1) indicated prevention, that is, for patients diagnosed with cancers in order to prevent second primary cancers and (2) selective prevention, that is, for relatives of patients with cancer to prevent primary cancers.

Limitations

The cross-sectional nature of sampling and retrospective assessment of pattern and use of SLT, which involves an element of memory bias, are the main limitations of our study. Moreover, the fact that this data were collected from a single center that focussed only on patients attending the department of ENT and Head and Neck Surgery is also an important limitation of the study. There may also be a chance that different caregivers might have followed up with the patients at different consultations. This might limit the implications of our findings.

CONCLUSIONS

Diagnosis of cancer indeed acts as a “teaching moment” for a significant proportion of users but the effect of the diagnosis is not extended to the family members as reflected from our study. Further, use of only one form of SLT, presence of 2 or more males in the family using SLT, and presence of another tobacco-related medical disorder in the family are associated with successfully quitting SLT.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

Financial support and sponsorship

This research received funding from the Chhattisgarh State Planning Commission, Naya Raipur, Government of Chhattisgarh (Ref: 1387/SPC/SNo/2017-18 Dt 28/11/2018).

Conflicts of interest

There are no conflicts of interest.