F1000Research F1000Research 2046-1402 F1000 Research Limited London, UK 10.12688/f1000research.135123.2 Study Protocol Articles Awareness regarding breast cancer among the female population in Wardha District

[version 2; peer review: 1 approved, 1 approved with reservations]

 Banmare Shraddha Conceptualization Writing – Original Draft Preparation https://orcid.org/0009-0004-7373-263X a 1 Mude Gaurav Supervision Validation Writing – Review & Editing 2 Clinical Research, School of Allied Health Sciences, Datta Meghe Institute Of Higher EducationEducation And Research, Wardha, Maharashtra, India Pharamacology, Datta Meghe College of Pharmacy , Datta Meghe Institute Higher Education and Research, Wardha, Maharashtra, India shrddhabanmare123@gmail.com

No competing interests were disclosed.

 9 11 2023 2023 12 1223 7 11 2023 Copyright: © 2023 Banmare 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.

Breast carcinoma is the second-leading cause of cancer mortality in women and the most prevalent carcinoma in female worldwide. It is most often presented as a pain-free lump or thickening in the breast. Modern breast carcinoma screening and medication methods have increased survival rates, with 50% of females now surviving the disease. Breast carcinoma accounts for 10.4% of all instances of carcinoma among females each year, with more than 1.5 million present cases. According to a previous study in the year 2015, approximately 570,000 deaths occur due to breast cancer. Whereas in 2015 there were 2.3 million females diagnosed with breast carcinoma and 685000 deaths caused worldwide and 7.8 million were viable who were diagnosed with breast carcinoma in the past 5 years. This number continues to increase especially in more advanced countries. A cross sectional study will be performed among Wardha district women to assess the awareness of breast carcinoma. Awareness will be assessed using a questionnaire in the year 2023. The previous data shows 27% awareness among the female population in the year 2020, and we now expect the results of this study to be between 50%-60% in the year 2023 in the Wardha district female population.

 Breast cancer Metastasis Awareness Risk factors Gene mutations Women's health Prognosis Biopsy The author(s) declared that no grants were involved in supporting this work. Amendments from Version 1

The conclusion added more information and mechanism of breast carcinoma should be added

 Introduction

A condition that involves immature cell development and the ability to invade or reach other parts of the body is known as carcinoma. 1 These elements act mostly by changing the qualities of a cell. 2 Carcinoma affected roughly 90.5 million people worldwide in 2015. 3 In 2019, yearly disease cases were developed by 23.6 million individuals and there were 10 million cases around the world, addressing over the earlier ten years increments of 26% and 21%, separately. 4 , 5 Following that, medical imaging and a biopsy are typically used to confirm the diagnosis. 6 The World Carcinoma Research Fund International estimates that there were 18.1 million current cases of carcinoma worldwide in 2020. 7 The world, addressing over the earlier ten years increments of 26% and 21%, separately. 4 , 5 Following that, medical imaging and a biopsy are typically used to confirm the diagnosis. 6 The World Carcinoma Research Fund International estimates that there were 18.1 million current cases of carcinoma worldwide in 2020. 7

Worldwide, breast carcinoma is the most common carcinoma among females and the second leading cause of death among females from carcinoma. 8 Fortunately, improvements in detection and treatment of breast carcinoma have enhanced survival rates, with 50% of females living 5 years following diagnosis. 9 A focus on quality of life in carcinoma research, with a specific focus on sexuality, has resulted from the realisation that female sexuality can be particularly problematic following breast carcinoma. 10 Breast carcinoma is the fifth most popular cause of carcinoma-related deaths worldwide, accounting for 10.4% of all female carcinoma incidences. 11 Worldwide, 2.3 million females will be diagnosed with breast carcinoma in 2020, which will result in 685 000 fatalities. As of the end of 2020, 7.8 million living females had breast carcinoma discovered within the preceding five years, making it the most common illness globally. Breast carcinoma accounts for more disability-adjusted life years (DALYs) lost by females worldwide than any other type of cancer. After puberty, breast cancer affects females in every nation, with an increasing prevalence in later life. 12 Worldwide, breast carcinoma affects over 1.5 million females annually, or 25% of all cancer patients. 13 Sex, age, oestrogen, family history, gene mutations, and an unhealthy lifestyle are risk factors that might raise a female's likelihood of getting breast carcinoma. 14

A destructive carcinoma that originates in the breast cells is called breast carcinoma. Like different tumors, there are a few factors that can raise the likelihood of getting breast malignant growths. Exposure to estrogen has been experimentally linked to DNA damage and hereditary alteration that can lead to breast carcinoma. Therefore, a higher chance of getting breast illness exists in people with a family history of ovarian or breast carcinoma.

Usually, the insusceptible framework seeks cancerous growth cells and cells with damaged DNA and destroys them. Breast carcinoma may develop if such an efficient immune defence and surveillance are not maintained.

There are many trillions of cells in the human body. These cells' development, maturity, division, and death are all governed by a strictly controlled cell cycle. During childhood, normal cells divide more quickly so that a person can grow. After reaching adulthood, cells divide to repair wounds and replace damaged ones. This cell division and development is constrained by the cell blue print or DNA and qualities that exist in the cell's core.

Cancer manifests itself when cells in a certain body component start to grow out of control. All forms of cancer, regardless of their origin, are caused by this unbalanced cell proliferation that gives rise to tumours and lesions. The carcinoma cells also exhibit rogue-like characteristics. These are a few frameworks for development factors and various intermediaries that allow stromal cells and epithelial cells to communicate. Breast cancer might potentially develop from changing them. 15

Carcinoma cells have extended lives and, rather than dying, they continue to develop and produce aberrant new cells. Also capable of invading other tissues are carcinoma cells. Normal cells are unable to accomplish this. Metastasis is the name for this quality.

Tumours are created from carcinoma cells, and they are fed by a new blood vessel network. Angiogenesis is a unique process because it prevents cancer cells from gaining access to nutrients and blood. 8

Causes

Each case of breast carcinoma has a unique cause, which is unknown. However, we do know a significant number of the factors associated with this disease.

For instance, risk factors related to your lifestyle, such as what you eat and how much exercise you do, might increase your likelihood of getting breast carcinoma. However, the precise mechanism through which some of these risk factors induce healthy cells to develop into carcinoma is unknown. Hormones also seem to have a role in a large number of breast carcinoma occurrences; however the exact process is still unclear.

We do know that gene changes or mutations can turn normal breast cells into carcinoma. While a woman with a family history of breast carcinoma may have inherited a defective gene that does not manifest on genetic testing, only around 10% of instances of breast carcinoma are associated with known aberrant genes that are inherited (passed down from parents). Most breast malignant growths (around 90%) are created from obtained (not acquired) quality changes. 15

Study objectives To assess the knowledge of breast carcinoma amongst females in the urban and rural areas in Wardha district. To explore the quality of life among females with breast carcinoma and to investigate its relationship with self-efficacy in Wardha district.

 Mechanisms of breast carcinoma

Genetic mutations: Mutations in certain genes can increase the risk of breast cancer. Two well-known genes associated with breast cancer are BRCA1 and BRCA2. Mutations in these genes can be inherited and significantly increase a person's susceptibility to breast and ovarian cancers.

Hormonal factors: Hormones play a crucial role in breast cancer development. Estrogen and progesterone, female sex hormones, can stimulate the growth of some breast cancer cells. Hormone receptor-positive breast cancers are those that have receptors for estrogen and/or progesterone, making them more responsive to hormonal therapies.

Environmental and lifestyle factors: Various environmental factors and lifestyle choices can impact the risk of developing breast cancer. These include:

Diet: A diet high in saturated fats and low in fruits and vegetables may increase the risk.

Alcohol consumption: Heavy alcohol use is associated with a higher risk of breast cancer.

Physical activity: Regular physical activity may lower the risk of breast cancer.

Reproductive history: Women who have their first child at a later age or never have children may have a slightly higher risk.

Hormone replacement therapy (HRT): Long-term use of HRT, especially a combination of estrogen and progestin, can increase the risk.

Radiation exposure: Exposure to ionizing radiation, such as radiation therapy used to treat other cancers, during a woman's younger years, can increase the risk of breast cancer later in life.

Inflammatory conditions: Chronic inflammatory conditions in the breast, such as mastitis or certain benign breast diseases, may slightly increase the risk of breast cancer.

Obesity: Obesity is associated with an increased risk of breast cancer, particularly in postmenopausal women, as fat tissue can produce estrogen, which can fuel the growth of some breast cancer cells.

Family history: A family history of breast cancer, especially in close relatives like a mother, sister, or daughter, can raise an individual's risk. This may be due to shared genetic factors or common environmental factors within families.

Age: The risk of breast cancer increases with age, with most cases occurring in women over the age of 50.

Breast cancer typically begins when cells in the breast undergo genetic changes (mutations) that cause them to grow and divide uncontrollably, forming a tumor. The tumor may be benign (non-cancerous) or malignant (cancerous). Malignant tumors have the potential to invade nearby tissues or spread to other parts of the body through the lymphatic system or bloodstream, a process known as metastasis.

 Protocol

Breast Carcinoma is the most widespread disease currently, 12 but few females are aware of the signs and symptoms of it and therefore it has poor prognosis, the purpose of this study is to assess the state of perceptions and beliefs specifically about breast carcinoma. My aim is to focus on the awareness of breast carcinoma among general females and make them aware of precaution and disease, with the support of this research results, the campaign and health professional bring awareness to people regarding breast cancer regarding breast carcinoma which will help in decreasing the rate of breast carcinoma among rural or urban area females or people. The population used in this study is part of a larger population that can be found in the upcoming study ‘Evaluating awareness of oral cancer and attitudes towards its screening practice in Vidarbha: A Cross-Sectional Study’ (Sweza. S. Bhaisare, Gaurav Mude).

 Methods

This is a cross-sectional study (observational study) that will take place over four months. The structure of the study is as follows:

A conceptual study of carcinoma and breast carcinoma will be conducted.

A conceptual study of awareness of breast carcinoma will be conducted.

Prior ethics committee permission will be obtained.

The recruitment of the general population will be done independently from the Wardha district.

Informed Consent forms will be taken from the participants who are willing to participate will be taken from the participants who are willing to participate.

The awareness of breast carcinoma and perception of breast carcinoma screening will be measured using a standardized questionary tool.

A face-to-face interview will be conducted to validate questionnaire responses to ensure accuracy

Any questions that arise while filling out the questionnaires will be answered in the interview.

Study design

The observational cross-sectional study of awareness will be conducted using the standardized questionary tool.

 Inclusion criteria

Age range

Subjects aged between 18 to 65.

Sex

Female

Location

Wardha district.

 Exclusion criteria

Males will be not included in the study.

 Participants

The subjects will be selected from the Vidarbha population and will include those who are willing to participate and fit the inclusion criteria. The researcher will recruit from the different regions of the Wardha district and will recruit from colleges, local resident hospitals and public places such as childcare centres.

 Sample size

As per the study by Gangane et al. in Wardha on breast cancer, prevalence of awareness about breast cancer was 65%. 19

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

Where,

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

Confidence interval =1.96

P = proportion of awareness about breast cancer = 65% = 0.65 Gangane

E = Error of Margin = 5% = 0.05 N = 1.96 2 ∗ 0.65 ∗ 1 − 0.52 0.05 2

N = 388

N= 308 subject needed in the study

 Data collection

Face-to-face interviews will be used to gather data while using a standardised questionnaire. The questionnaire will include questions on demographics, breast cancer awareness, risk factors, and sources of information. The researcher will take the interview of participant at the same place as recruitment. The duration of the interviews will not be more than 15 minutes. A questionnaire form will be used as a tool to record data related to interview. The questionnaire will be pre-tested to ensure its validity and reliability. As part of the interview process, participants will be questioned about their overall experience in completing the questionnaire, with particular emphasis on identifying any items they found confusing or difficult to comprehend. Moreover, they will be encouraged to offer constructive feedback and suggestions for enhancing the questionnaire's quality. The interview will make sure that the questionnaire forms filled are carefully evaluated and refined.

 Expected dates of data collection

The data will be collected in May 2023-August 2023.

 Expected dates of recruitment

The first subject was recruited on 11 May 2023 and recruitment will continue until 11 September 2023. 308 participants will be recruited.

 Data analysis

The statistical package for social sciences (SPSS) software will be used to analyse the questionnaire data. We will use descriptive statistics to summarise the data, including means, frequencies, and percentages. The chi-square test will be performed to determine the variables that influence breast cancer awareness.

 Dissemination

The study will be published in an indexed journal.

 Study status

The recruitment of participants started from May 2023. As participants arrive, we engage them and include them in the study. As of now, 120 participants have participated in the study.

 Discussion

Those who use hormone replacement therapy (HRT) have a higher risk of breast cancer. Uncontrolled cell division frequently results in a benign or malignant tumour, which is known as a carcinoma. These tumours have the potential to spread to distant organs or tissues by infecting surrounding tissues. 16 Breast cancer breast masses often have favourable features. Non-cancerous breast tumours are abnormal growths, but they do not spread outside the breast and pose no threat to life. However, some benign breast lumps can increase a woman's risk of breast cancer. 17 Breast cancer spreads swiftly when the tumour cells enter the blood or lymphatic system. Carcinoma cells start to multiply when they are dispersed throughout the body. Age, family history, and personal history (having a diagnosis of breast carcinoma in one breast increases the risk of breast cancer) the risk of carcinoma in the other breast, early menstrual cycle or being menopausal, race (white women have a greater risk of growing breast carcinoma), having no children or having one’s first child are known risk factors which can cause breast carcinoma. Women with immediate relatives who have the disease as well as those who have more dense breast tissue are at much higher risk of developing breast carcinoma. Early menarche age, nulliparity, late first-birth age, inability to breastfeed, usage of oral contraceptives, menopausal status, and menopausal hormone treatment are all reproductive risk factors. 30% of breast carcinoma incidence has sharply increased in several LMICs due to changes in lifestyle, reproductive factors, and greater life expectancy. 18

Breast carcinoma is the most common malignancy in women worldwide and the second major cause of carcinoma death in women. 8 Fortunately, improvements in breast carcinoma detection and treatment have increased survival rates, with 50% of women still alive five years after diagnosis. 9 Since it is now understood that female sexuality can be particularly problematic following breast carcinoma, there has been an increased focus on quality of life concerns in breast carcinoma research. 10

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/2023/596

The study protocol will be explained to the participating subjects. Further, a written informed consent form will be obtained from the participants.

 Expected outcome

We expect to find a low level of awareness of breast carcinoma among females in Wardha district, India. Factors such as age, education, and family history of breast cancer may be associated with breast carcinoma awareness. We also expect to find that the primary source of breast carcinoma information among females is healthcare professionals.

 Implications

The findings of this study will provide insight into the level of breast cancer awareness among women in Wardha district, India. This information can be used to develop targeted health education programs to improve breast cancer awareness and promote early detection and treatment.

 Conclusion

For early identification and treatment of breast carcinoma, which is a major public health issue in India, increased knowledge is crucial. Examining females’ knowledge about breast carcinoma in India's Wardha area is the goal of this study. The results will be valuable in creating strategies to increase breast carcinoma awareness and enhance female health outcomes. Breast carcinoma is the most common malignancy in women worldwide and the second major cause of carcinoma death in women. All forms of cancer, regardless of their origin, are caused by this unbalanced cell proliferation that gives rise to tumours and lesions. A destructive carcinoma that originates in the breast cells is called breast carcinoma. Cancer manifests itself when cells in a certain body component start to grow out of control.

 Data availability

No data are associated with this article.

 References World Health Organization:12 September 2018. Retrieved 19 December 2018. World Health Organization:2014. pp. Chapter 1.1. ISBN 978-92-832-0429-9. Archived from the original on 12 July 2017. Vos T : Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016;388(10053):1545–1602. 27733282 10.1016/S0140-6736(16)31678-6 PMC5055577 Kocarnik JM : Cancer incidence, mortality, years of life lost, years lived with disability, and disability-adjusted life years for 29 cancer groups from 2010 to 2019: a systematic analysis for the global burden of disease study 2019. JAMA Oncol. 2022;8(3):420–444. 34967848 10.1001/jamaoncol.2021.6987 Sciacovelli M : Metabolic drivers in hereditary cancer syndromes. Annual Review of Cancer Biology. 2020;4:77–97. 10.1146/annurev-cancerbio-030419-033612 American Cancer Society: 29 January 2013. Archived from the original on 14 July 2014. Retrieved 10 June 2014. Harnisch-Weidauer L Generales M Resa R : Cancer rates by country [updated 2022]. Dana-Farber Cancer Institute. Dana;2023, June 22. Reference Source World Health Organisation: Breast cancer: prevention and control. 2009 [web page; cited 10.12.2009]. Reference Source Berterö C Wilmoth MC : Breast cancer diagnosis and its treatment affecting the self: a meta-synthesis. Cancer Nurs. 2007;30(3):194–202. 10.1097/01.NCC.0000270707.80037.4c Thomas-MacLean R : Beyond dichotomies of health and illness: life after breast cancer. Nurs. Inq. 2005;12(3):200–209. 16083471 10.1111/j.1440-1800.2005.00268.x Cancer-Its various types along with causes, symptoms, treatments and stages. Cancer info guide. 2009. (15 Mar. 2010). Reference Source Reference Source Stewart BW Wild CP : World Cancer Report 2014. Geneva, Switzerland: WHO Press;2014. Breast cancer. Geneva, Switzerland: WHO; Reference Source Osei-Afriyie S : Breast cancer awareness, risk factors and screening practices among future health professionals in Ghana: A cross-sectional study. PLoS One. 2021;16(6):e0253373. 34166407 10.1371/journal.pone.0253373 PMC8224936 Majeed W : Breast cancer: major risk factors and recent developments in treatment. Asian Pac. J. Cancer Prev. 2014;15(8):3353–3358. 10.7314/APJCP.2014.15.8.3353 Irshath U Ahamed MY M. Vara Prasanna Rao. : Awareness of breast cancer and breast self-examination among female students in South Chennai. Breast. 2019;14:15. Shulman LN Willett W Sievers A : Breast cancer in developing countries: opportunities for improved survival. J. Oncol. 2010;2010:595167. Gangane N Ng N Sebastián MS : Women’s Knowledge, Attitudes, and Practices about Breast Cancer in a Rural District of Central India. 10.7314/APJCP.2015.16.16.6863 10.5256/f1000research.158630.r251479 Reviewer response for version 2 Brahmachari Swagata 1 Referee https://orcid.org/0000-0002-2688-1286 Department of Surgery, All India Institute of Medical Sciences, Bhopal, Madhya Pradesh, India

Competing interests: No competing interests were disclosed.

 10 4 2024 Copyright: © 2024 Brahmachari S 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 approve-with-reservations

Well-written article.

To summarise, the study protocol will assess the awareness of female patients in Wardha District regarding breast carcinoma in 2023. It is a cross-sectional observational study that will require a validated questionnaire filled out by the investigator by face-to-face questioning within four months.

The inclusion and exclusion criteria is mentioned along with a proper sample size calculation and data collection and analysis. Expected outcome is well-explained.

Some minor changes are advisable-

# Breast carcinoma is ever-increasing, so recent data and references are required (Ref-8,11)

# Reference 12 is not traceable

# Flow chart/consort Diagram not available which is a requirement

# A Gantt diagram for the timeline will be desirable

# In the first point of the methodology". A conceptual study of carcinoma and breast carcinoma will be conducted." How it will be conducted has to be mentioned. 

Observations for the questions in peer review -

# It is a study protocol, so data is not yet analysed, so the data set is not available.

# In methodology, the questionnaire will be validated, so at the present stage cannot be replicated.

Is the study design appropriate for the research question?

Yes

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?

Not applicable

Reviewer Expertise:

Breast Diseases.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

 10.5256/f1000research.158630.r221785 Reviewer response for version 2 Wu Dong-Dong 1 Referee https://orcid.org/0000-0001-6739-8437 Henan International Joint Laboratory for Nuclear Protein Regulation, Henan University, Kaifeng, Henan, China

Competing interests: No competing interests were disclosed.

 30 11 2023 Copyright: © 2023 Wu DD 2023 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 approve

Accept.

Is the study design appropriate for the research question?

Yes

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

Yes

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

Yes

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

Yes

Reviewer Expertise:

Cancer

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

 10.5256/f1000research.148226.r218910 Reviewer response for version 1 Wu Dong-Dong 1 Referee https://orcid.org/0000-0001-6739-8437 Henan International Joint Laboratory for Nuclear Protein Regulation, Henan University, Kaifeng, Henan, China

Competing interests: No competing interests were disclosed.

 1 11 2023 Copyright: © 2023 Wu DD 2023 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 approve-with-reservations

The manuscript by Shraddha Banmare et al., “Awareness regarding breast cancer among the female population in Wardha District”, demonstrated that a cross sectional study will be performed among Wardha district women to assess the awareness of breast carcinoma. Awareness will be assessed using a questionnaire in the year 2023. The previous data shows 27% awareness among the female population in the year 2020, and we now expect the results of this study to be between 50%-60% in the year 2023 in the Wardha district female population. Although authors have done many experiments to support their findings, there are some limitations as mentioned below: 

The authors should add more information in “Conclusion”.

The authors should deeply clarify the mechanism of breast cancer.

Is the study design appropriate for the research question?

Yes

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

Yes

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

Yes

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

Yes

Reviewer Expertise:

Cancer

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

Banmare Shraddha Clinical Research, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India

Competing interests: No competing interests were disclosed.

 28 12 2023

respected sir/Madam

I Given all response