F1000Research F1000Research 2046-1402 F1000 Research Limited London, UK 10.12688/f1000research.135122.1 Study Protocol Articles Evaluating awareness of oral cancer and attitudes towards its screening practice in Vidarbha: A cross-sectional study

[version 1; peer review: 2 not approved]

 Bhaisare Sweza Conceptualization Writing – Original Draft Preparation https://orcid.org/0009-0008-7433-4595 a 1 Mude Gaurav Validation Writing – Review & Editing 2 Clinical Research, School of Allied Health Sciences, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India Pharmacology, Datta Meghe College of Pharmacy, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India swezabhaisare2000@gmail.com

No competing interests were disclosed.

 22 9 2023 2023 12 1190 13 9 2023 Copyright: © 2023 Bhaisare S and Mude G 2023 This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Background: In various parts of the country, oral cancer is a serious and rapidly growing issue. India has an elevated number of mouth cancer and is growing year after year. mouth cancer is a disease that can be avoided and is mostly affected by lifestyle habits such as chewing tobacco and smoking. Awareness concerning the risk factors, signs, and symptoms of mouth cancer may assist in the early detection and therapy of the condition, which will help in increasing the survival rate of the population. The purpose of this investigation is to estimate mouth cancer awareness in terms of symptoms, signs and causal factors, and information sources. Methods: A cross-sectional population-based questionnaire survey of randomly selected participants will be conducted among 381 participants however we will try to include a larger sample size in order to improve the precision in the Wardha district. The results will be analysed using appropriate statistical methods and a conclusion will be drawn on the basis of observation. This is a research protocol and this study aims to evaluate the awareness about oral cancer and attitude towards dental screening of oral cancer.

 Oral Cancer Awareness dental screening knowledge Attitude condition detection educating The author(s) declared that no grants were involved in supporting this work. Introduction

Cancer is a scientific term for a large group of diseases that can affect any part of the body. 1 The other term which can be used for it is malignant tumors and neoplasms. It can influence the different areas of the mouth such as the lips, mouth, and oral cavity. Cancer is the growth of abnormal cells throughout the body which can affect neighboring parts of the body and can develop into various organs which is referred to as metastasis. The prime source of death is widespread metastasis. In 2020, 10 million deaths have been reported, the most common were breast (2.26 million cases), lung (2.21 million cases), colon and rectum (1.93 million cases), prostate (1.41 million cases), and stomach cancer (1.09 million cases). 1

Oral cancer is described as squamous cell carcinoma of the oropharynx, oral cavity, and lip. It is a major issue and particularly for dental surgeons. Each year 400,000 cases of mouth cancer are reported and most of them developed in Asian nations, such as Indonesia, Bangladesh, Pakistan, Sri Lanka, and India. Oral cavity and lip cancer was common in 2020 and has reported more than 377,700 cases and is the sixteenth most common cancer, the eleventh most common cancer in males, and the eighteenth usual cancer in females. The mouth cancer occurrence rate in 2020 in India was 219,722 and ASR ( age-standardized rates) = 16.0 followed by women 45,347 and ASR of 6.7. Mouth and oral cancer mortality in 2020 were 121.096 and ASR = 8.9. followed by women at 26,399 and ASR = 3.9. 2

Oral cancer is a life-threatening disease all over the world and has a very poor prognosis with a five-year survival rate. Its survival rate can improve by 80% if identified within early tiers (1 and 2 stages). 3 50% of patients with oral cancer are diagnosed at the last stage (stages 3 and 4) as most patients do not seek medical attention until they discover signs such as bleeding, pain, or tumors in the oral area. 4 Radiotherapy or concurrent chemotherapy is still a conventional treatment in oral cancer but has effects on the daily functionality of the oral cavity. 5 When there is a diagnostic delay the chance of having last-stage oral cancer is remarkably higher. 6 And the diagnostic delay is linked to low awareness of oral cancer among people and its symptoms and risk factors. 7

Poor compliance (25.7%) to oral cancer screening after the invitation has been linked to a possible lack of public awareness of this disease. 8 So, the first step in which we can contribute in decreasing the occurrence of mouth cancer is by informing and educating the population on troubles relating to the known risk factors and dental screening. As the awareness about oral cancer study had not been concluded previously in our Wardha District. so here is our aim to appraise the awareness of oral cancer and attitudes toward screening practices for oral cancer among the rural and semi-urban population in district Wardha. With the help of its outcome, the health professional will try to educate and inform people about oral cancer which will help in reducing the incidence of mouth cancer in Wardha district (India).

 Objectives

To assess the awareness of mouth cancer and attitudes towards its screening practice for oral cancer among the ruler and semi-urban population in district Wardha.

To match their level of knowledge and attitude related to oral cancer based on their age, gender, and level of education.

Protocol

The population used in this study is part of a larger population that can also be found in the upcoming article ‘Awareness regarding breast cancer among the female population in Wardha District’ (Shraddha Banmare, Gaurav Mude).

Methods

Study design: The observational cross-sectional study of awareness and attitude towards screening will be done by using a standardized questionnaire. A conceptual study of oral cancer and its awareness will be done. The study will be completed over a period of 4 months. Prior ethics committee permission has been obtained from the institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research. The standardized questionnaire is derived from previously published articles. After explaining the objectives of the study informed consent will be obtained from the volunteers who are willing to participate. The subject will complete the standardized questionnaire 24 which includes a list of questions that will help in assessing the awareness of mouth cancer and attitudes toward its screening practice for oral cancer. The primary outcome will be assessing the awareness of mouth cancer and attitudes toward its screening practice in the Wardha district. The secondary outcome will be to match their level of knowledge and attitude related to oral cancer based on their age, gender, and level of education. The gathered information using a standardized questionnaire will be compiled and examined.

 Sample size

Cochran Formula for sample size: N = Z 1 − α / 2 2 ∗ p ∗ 1 − p E 2

Where,

Z 1 2 – α/2 = is the level of significance at 5% i.e., 95%

P = Where aware of oral cancer = 55% = 0.55

Confidence interval = 1.96

E = 5% will be Error of Margin = 0.05 n = 1.96 2 × 0.55 × 1 − 0.55 0.05 2

n = 381.24

n = 390 participants needed in the sample.

The study will however try to include a larger sample in order to improve its precision.

Ref. 9.

Techniques of sampling: Simple random sampling will be used.

 Selection of subjects

Inclusion criteria

Age range

Subjects aged above 18 to 65.

Gender

Both male and female subjects will be included randomly.

Participants who are willing to participate after explaining the protocol.

Exclusion criteria

Participants who are not willing to participate after explaining the protocol.

 Sources of participants

Participants will be randomly assigned from the rural, semi-urban, and urban residential areas of Wardha district. Subjects will be recruited from various locations like hospitals, local institutions, homes, and from the campaigns in public spaces.

 Method of data collection

Instrument: the researchers prepared a structured questionnaire consisting of MCQs.

Steps of data collection

Step 1: Permission is obtained prior from the ethics committee for the data collection.

Step 2: Introduction between the participants and the researcher.

Step 3: The participants will be assigned by using a random sampling method.

Step 4: ICF 25 will be taken from the participants who are willing to participate, after explaining the study purpose.

Step 5: A standardized questionnaire will be filled out by the subjects with the help of face-to-face interaction.

Expected dates of data collection

The data will be collected from May 2023 to August 2023.

Expected dates of recruitment

The first subject was recruited on the 1 st of May and 390 participants will be recruited by the end of August 2023

Data analysis and statistical plan

The data will be analyzed according to socio-demographic and geographic factors and attitudes toward dental screening. Frequency percentage, mean, and SD will be calculated and, to understand the relationship between various demographic variables and knowledge, the chi-square test will be used. All the statistical analysis will be performed using SPSS Software, version 27.0 p < 0.05.

Dissemination

Once the study is completed it will be published in an indexed journal.

Study status

The study has started. The study has not been completed and no data analysis has been performed.

 Discussion

Oral cancer can build at the lips, salivary glands, tongue, lining of the mouth, buccal area, and other locations. Many different habits such as drinking, smoking, chewing tobacco, Paan, and flavouring agents are used in high amounts in different parts of the country. 10 Tobacco use is widespread among the residents and the community. 11 Consuming alcohol and use of tobacco are regarded as the primary factor for the occurrence of mouth cancer. 12 Snuff is the most widely used smokeless tobacco in Pakistan and sun and heat dried tobacco leaves, slaked lime, tree bark ash, and flavouring and colouring agents are used to make it. 13 50% of oral cancers are thought to be caused by precursor lesions. 14 Changes in the concentration of intrinsic fluorophores such as collagen, nicotinamide adenine dinucleotide (NADH), flavin adenine dinucleotide (FAD), and porphyrin in human oral tissue mark the progression of oral mucosal lesions. 15 Therefore, it’s important to do proper management and early detection of malignant lesions which helps in prevention. 16

Genetics also plays a crucial part in the development of cancer and a high chance of developing buccal mucosa and tongue cancer. 17 However, it’s hard to link genetics or family with oral cancer as there is the existence of other causal factors such as chewing tobacco, etc. Some researchers believe that some people are vulnerable to developing oral cancer those who are born with the inability to metabolize carcinogens are unable to restore DNA damage. 18 Chronic inflammation is also one of the vital parts in the occurrence of cancers such as the mouth and pharyngeal neoplasm. The main viruses involved in the growth of mouth cancer are HPV infection and human immunodeficiency virus (HIV). Human papillomavirus is a tiny virus with a circular double-stranded DNA genome of approximately 8 kb in size. HPV infection is the main causal factor for oropharyngeal squamous cell carcinoma caused by sexual activity. The prevalence peak was found in older people, especially in men showing a longer duration of infection at older ages. 19

Having knowledge about the prior detection and sign and symptoms of oral cancer will assist human beings to diagnose early before getting to the higher stage of oral cancer. However, more than 30% of patients delay for extra three months prior to seeking medical attention for the signs and symptoms of oral cancer. 20 The prevalent reason for the delay in seeking medical treatment for signs and symptoms of oral cancer has been reported as a lack of awareness about mouth cancer which leads to the misattribution of symptoms. 21 Warnakalasuriya reported a need for awareness about oral cancer in the United Kingdom, as well as a lack of awareness about the prior signs and symptoms of the disease. 22 In India Gorakhpur, the highest rate of awareness was observed among high school graduates and was low among the illiterates which pointed to further knowledge among Indian people about oral cancer. 23

Opportunistic screening for signs and symptoms among patients who receive dental routine care settings could aid in the early detection of oral cancer. Informing the patient that they are being screened for the early detection of oral cancer, especially the people who are at high risk could be an opportunity for the clinician to provide people with details about the existence, risk factors, sign and symptoms, and prevention of mouth cancer. The British Dental Association (BDA) recommends the patient must be informed that mouth cancer screening is being performed. 8

Bias

Minimum bias will occur as patients will be randomly selected based on the exclusion and inclusion criteria.

 Ethical considerations

The studies involving human participants were reviewed and approved by the institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (Deemed to be University) Wardha – 442107, Maharashtra, India.

Ref. No. DMIHER (DU)/IEC/2023/593.

The study protocol will be explained to the participating subjects.

Further, a written informed consent form will be obtained from the participants.

 Data availability Underlying data

No data are associated with this article.

 Extended data

Zenodo: questionary for oral cancer awareness, https://zenodo.org/record/8005341. 24

Zenodo: English ICF and consent form, https://zenodo.org/record/8229957. 25

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

 Acknowledgments

The author would like to acknowledge the support from the Department of Clinical Research, DMIHER, AVBRH, Sawangi, Wardha, India.

 References Cancer: Accessed: August 9, 2023. Reference Source Mouth and oral cancer statistics. Reference Source Lingen MW Kalmar JR Karrison T : Critical evaluation of diagnostic aids for the detection of oral cancer. Oral Oncol. 2008;44:10–22. 17825602 10.1016/j.oraloncology.2007.06.011 PMC2424250 Silverman S Kerr AR Epstein JB : Oral and Pharyngeal Cancer Control and Early Detection. J. Cancer Educ. 2010;25:279–281. 20204575 10.1007/s13187-010-0045-6 PMC2933804. Yuwanati M Gondivkar S Sarode SC : Oral Health-Related Quality of Life in Oral Cancer Patients: Systematic Review and Meta-Analysis. Future Oncol. 2021;17(8):979–990. 10.2217/fon-2020-0881. McCullough M Prasad G Farah C : Oral mucosal malignancy and potentially malignant lesions: An update on the epidemiology, risk factors, diagnosis and management. Aust. Dent. J. 2010;55(Suppl. 1):61–65. 20553246 10.1111/j.1834-7819.2010.01200.x. Abu-Serriah M Critchlow H Whitters CJ : Removal of partially erupted third molars using an Erbium (Er):YAG laser: a randomised controlled clinical trial. Br. J. Oral Maxillofac. Surg. 2004;42:203–208. 15121264 10.1016/j.bjoms.2004.02.006 Jullien JA Zakrzewska JM Downer MC : Attendance and compliance at an oral cancer screening programme in general medical practice. Eur. J. Cancer (Oral Oncol). 1995;31:202–206. 10.1016/0964-1955(94)00048-9. Bhat PK Sushma SG Jayachandra MY : Awareness about oral cancer among nonhealth professional students - A cross-sectional study in Bengaluru city. J. Oral Maxillofac. Pathol. JOMFP. 2020;24:492–498. 10.4103/jomfp. JOMFP_304_20 Gómez I Seoane J Varela-Centelles P : Is diagnostic delay related to advanced-stage oral cancer? A meta-analysis. Eur. J. Oral Sci. 2009;117:541–546. 19758250 10.1111/j.1600-0722.2009.00672.x. Goyal A Sharma A Agarwal S : Determinants of Tobacco Use among Children of a Rural Village in India: An Exploratory Qualitative Study. Asian Pac. J. Cancer Prev. 2020;21(1):81–86. 31983168 10.31557/APJCP.2020.21.1.81 PMC7294019. Hamada GS Bos AJ Kasuga H : Comparative epidemiology of oral cancer in Brazil and India. Tokai J. Exp. Clin. Med. 1991;16:63–72. 1780908 Zahir R Khan ZA Aleem B : Association of High Immunohistochemical Expression of Minichromosome Maintenance 3 with Human Oral Squamous Cell Carcinoma—A Preliminary Study. Diagnostics. 2023;13:13. 10.3390/diagnostics13010061 Jensen K Afroze S Munshi MK : Mechanisms for nicotine in the development and progression of gastrointestinal cancers. Transl. Gastroint. Cancer. 2012;1:81–87. Sah AN Kumar P Pradhan A : In-vivo Testing of Oral Mucosal Lesions with an In-house Developed Portable Imaging Device and Comparison with Spectroscopy Results. J. Fluoresc. 2023;33:1375–1383. 10.1007/s10895-023-03152-z. Sathiasekar AC Mathew DG Jaish Lal MS : Oral field cancerization and its clinical implications in the management in potentially malignant disorders. J. Pharm. Bioallied Sci. 2017;9(Suppl 1):S23–S25. 29284929 10.4103/jpbs.JPBS_109_17. Irani S : miRNAs signature in head and neck squamous cell carcinoma metastasis: A literature review. J. Dent (Shiraz, Iran). 2016;17:71–83. Kim KM Kim YM Shim YS : Epidemiologic survey of head and neck cancers in Korea. J. Korean Med. Sci. 2003;18:80–87. 10.3346/jkms.2003.18.1.80. Shivappa N Hebert JR Rosato V : Inflammatory potential of diet and risk of oral and pharyngeal cancer in a large case-control study from Italy. Int. J. Cancer. 2017;141:471–479. 28340515 10.1002/ijc.30711 PMC5464969. Shigeishi H Sugiyama M : Risk factors for oral human papillomavirus infection in healthy individuals: A systematic review and meta-analysis. J. Clin. Med. Res. 2016;8:721–729. 27635177 10.14740/jocmr2545w PMC5012241. Scott SE Grunfeld EA Mcgurk M : Patient’s delay in oral cancer: a systematic review. Community Dent. Oral Epidemiol. 2006;34:337–343. 16948672 10.1111/j.1600-0528.2006.00290. Speight PM Palmer S Moles DR : The cost-effectiveness of screening for oral cancer in primary care. Health Technol. Assess. 2006;10:1–144. 10.3310/hta10140. Agrawal M Pandey S Jain S : Oral Cancer Awareness of the General Public in Gorakhpur City, India. Asian Pac. J. Cancer Prev. 2012;13:5195–5199. 23244134 10.7314/APJCP.2012.13.10.5195. Bhaisare S Mude G : Questionary-Sweza bhaisare (Version V1). Zenodo. 2023. 10.5281/zenodo.8005341 Bhaisare SS Mude G : English Informed consent form (Version V1). Zenodo. 2023. 10.5281/zenodo.8229957 10.5256/f1000research.148225.r252600 Reviewer response for version 1 Jager Derk Hendrik Jan 1 Referee https://orcid.org/0000-0002-3006-2128 Department of Oral and Maxillofacial Surgery/Oral Pathology, Amsterdam University Medical Center, Location Vrije Universiteit, Amsterdam and Academic Center for Dentistry, Amsterdam Institute for Infection and Immunity, Amsterdam, Netherlands Antilles

Competing interests: No competing interests were disclosed.

 2 5 2024 Copyright: © 2024 Jager DHJ 2024 This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. recommendation reject

Title:

- Name in which country the research will take place. Readers may not know where Vidarbha is.

Overall

- Try to adhere to the SPIRIT guidelines and checklist. See here: https://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/

Abstract:

- Mouth cancer and oral cancer are used both. I would like to recommend using oral cancer.

- Name in which country the Wardha district is located. Furthermore, it is confusing that a different name is used in the title (Vidarbha).

Introduction

- Second paragraph: the definition of Oral cancer is incorrect. Carcinoma of the oropharynx does not fall under oral cancer but under Oropharyngeal squamous cell carcinoma (OPSCC). So it is better to use the following division:

 Oral Cancer (OC)/Oral Squamous Cell carcinoma (OSCC): oral cavity and lip

 Oropharyngeal squamous cell carcinoma (OPSCC): oropharynx

- It is preferable not to use “mouth cancer” but use OC/OSCC. See above

- A prevalence of 400,000 new cases per year is mentioned. In which countries/region? Does this only concern oral cancer (OC) or also OPSCC? Or even Head and Neck cancer? Please clarify.

- “The mouth cancer occurrence rate in 2020 in India was 219,722 and ASR (age-standardized rates) = 16.0 followed by women 45,347 and ASR of 6.7. Mouth and oral cancer mortality in 2020 were 121,096 and ASR = 8.9. followed by women at 26,399 and ASR = 3.9”. This sentence is unclear. Explain better to the reader what ASR is. Rewrites this sentence. Do not use a “=” sign in the sentence. Why are both “mouth” and “oral” cancer used here? What's the difference?

- “Oral cancer is a life-threatening disease all over the world and has a very poor prognosis with a five-year survival rate.” What is the 5-year survival rate?

- Explain “stages 1 to 4”.

- “As the awareness about oral cancer study had not been concluded previously in our Wardha District. so here is our aim to appreciate the awareness of oral cancer and attitudes toward screening practices for oral cancer among the rural and semi urban population in Wardha district”. Please rewrite this sentence. Furthermore, the objectives are also mentioned in the next paragraph.

Objectives:

- The 2nd objective is not clear to me. Match to what?

Protocol:

- Sample size and selection of subjects: please transform these to a narrative form.

- MCQs: please write this abbreviation in full

- Please use a narrative way of presenting the protocol

- Exclusion: is a history of cancer an exclusion criterion? What are the in/exclusion criteria?

Discussion:

- “oral cancer can build” Please rewrite

- What is Paan?

- Much attention is paid in the Discussion to the possible causes of OC and OPSCC. This has only limited relevance for this study. Nothing is said about possible pitfalls or other complicating matters when conducting the study. Also discuss expected outcomes.

Is the study design appropriate for the research question?

Partly

Is the rationale for, and objectives of, the study clearly described?

Partly

Are sufficient details of the methods provided to allow replication by others?

Partly

Are the datasets clearly presented in a useable and accessible format?

Not applicable

Reviewer Expertise:

Knowledge and attitudes of oral health students and professionals related to HPV-related oropharyngeal cancer, Sjogren's syndrome, Hyposalivation

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

 10.5256/f1000research.148225.r246824 Reviewer response for version 1 Daud Ali Mohammad 1 Referee https://orcid.org/0000-0003-3752-2331 Department of Pharmacy, Mohammed Al-Mana College for Medical Sciences, Dammam, Saudi Arabia

Competing interests: No competing interests were disclosed.

 26 2 2024 Copyright: © 2024 Daud Ali M 2024 This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. recommendation reject

Kindly write the rationale of the study in the last paragraph separately

Kindly align the introduction with the study's primary and secondary objectives.

Kindly add the identification of the study population.

How survey tools kindly were designed.

Kindly describe the questionnaire/Tools validation description.

Kindly add an ethical approval number under the heading Ethical consideration

Kindly add the study site

Kindly add study participants' inclusion and exclusion criteria

How invited the study participants.

How to minimize study participants' biasing

How is sample size calculated kindly add in the manuscript under methods

Kindly add how data is collected as well as how study participants are enrolled in the study for data collection.

How was the survey conducted through a hard copy of the questionnaire or online?

 Others

Kindly add study limitations.

Is the study design appropriate for the research question?

Partly

Is the rationale for, and objectives of, the study clearly described?

Yes

Are sufficient details of the methods provided to allow replication by others?

Partly

Are the datasets clearly presented in a useable and accessible format?

Partly

Reviewer Expertise:

Pharmacy practice and clinical pharmacy.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.