Running head: RESEARCH PROPOSAL 1

RESEARCH PROPOSAL 13

Research Proposal

The Influence of Human Papillomavirus in the Occurrence of Abnormal PAP Smear and Cervical Cancer in Women aged 21-65 years

Johan Mary Jimenez

Turabo University

NURS 502

October 5, 2016

Abstract

Cervical cancer, also known as Carcinoma of Uterine Cervix, is the fourth most common malignancy in the world according to World Cancer Research Fund International. The establishment of the Pap smear or Papa Nicolaus in the 1940s caused an important reduction in the appearance of new cases of cervical cancer. Despite the emergence of pap screening and the different and extremely effective programs for the prevention of this disease, and according with the National Cancer Institute that incidence rates have reduced 45 percent and mortality rates have declined, Cervical Cancer still remains a public health problem in the United Stated. The purpose of this research is to determine the influence of Human Papillomavirus in the occurrence of abnormal PAP Smear and cervical cancer and increase awareness of the population about this latent disease through promoting talks about cervical cancer and the prevention of HPV infection. The investigation to be conducted will be an exempt study with the general objective of determining the influence of Human Papillomavirus in the occurrence of abnormal PAP Smear and Cervical Cancer in women aged 21 to 65 years. The technique to be used will be review medical records in order to identify existing data about infections for Human Papilloma Virus associated with cervical cancer, identify numbers of sexual partners, HPV vaccination history, Abnormal PAP Smear history, and Papanicolaus screening, including HPV/cytology co-testing regular check-up. All information related with the identity of the participants will be kept private and confidential and will be protected at all times.

Key words: Human Papilloma Virus, Abnormal PAP Smear, Cervical Cancer

Table of Content

I. Introduction………………………………………………………………………………4

II. Statement of the Problem………………………………………………………………….5

III. Cervical Cancer Background………………………………………………………………6

IV. Methodology…………………………………………………………………………….10

V. Analysis of data…………………………………………………………………………12

VI. References………………………………………………………………………………13

VII. Appendix…………………………………………………………………………………15

The Influence of Human Papillomavirus in the Occurrence of Abnormal PAP Smear and Cervical Cancer in Women aged 21-65 years

I. Introduction

Cervical cancer, also known as Carcinoma of Uterine Cervix, is the fourth most frequent malignancy in the world according to World Cancer Research Fund International (Ferlaj J et al., 2014). The establishment of the Pap smear or Papa Nicolaus in the 1940s caused an important reduction in the appearance of new cases of cervical cancer (Olusola Adegoke et al., 2012). Despite the emergence of this and the different and extremely effective programs for the prevention of this disease, and according with the National Cancer Institute that incidence rates have reduced 45 percent and mortality rates have declined, Cervical Cancer still remains a public health problem in the United Stated (NIH, 2014).

Although Carcinoma of the Uterine Cervix rates are generally diminishing among women in developed countries because of the availability of the PAP Smear and HPV vaccine, in 2013, the most recent data according to the CDC, 11,955 women in the United States were diagnosed with cervical cancer and 4,217 died from cervical cancer (CDC, 2016). The estimates for cervical cancer in the United States for 2016 according with The American Cancer Society’s about 12,990 new cases of invasive cervical cancer will be diagnosed and about 4,120 women will die from cervical cancer (Society, 2016).

After many years of research and different hypothesis, it was established that the virus responsible for cellular changes that precede cervical cancer is the Human Papilloma Virus (HPV). Nowadays, it is known that the more than 100 types of HPV mainly types 16 and 18 genotypes are responsible for the development of cervical cancer. HPV 16 and 18 are the most frequent oncogenic types causing approximately 70% of all cervical cancers worldwide. Another types genotypes like 6 and 11can also be responsible of genital warts. Human Papilloma Virus is a highly transmissible in most populations. Women with continual high-risk HPV infections have a high possibility to develop cervical cancer. Since the discovery of the HPV as mainly cause of cervix uterine cancer, HPA’s screening become an important step in the early detection of cervical cancer. With the development and approval of the vaccine by the FDA, Gardasil in 2006 and Cervarix in 2009, in adolescent girls and young woman, cancer cervical could be eradicated if the protocols are widely and wisely implemented (Castellsagué, 2008).

II. Statement of the Problem

Does affect Human Papillomavirus in the occurrence of abnormal PAP Smear and Cervical Cancer in women 21 to 65 years?

Research Objectives

General Objective

Determine the influence of Human Papillomavirus in the occurrence of abnormal PAP Smear and cervical cancer in women aged 21 to 65 years.

Specific Objectives

1. Identify infections for Human Papilloma Virus associated with cervical cancer.

2. Identify numbers of sexual partners.

3. HPV vaccination history.

4. Abnormal PAP Smear history.

5. Papanicolaus screening, including HPV/cytology co-testing.

6. Provide educational talks about cervical cancer and HPV prevention.

Purpose of the Investigation

Despite that Cervical Cancer incidence rates have reduced about 45 percent and mortality rates have declined, Cervical Cancer still remains a public health problem in the United Stated.

The purpose of this research is to determine the influence of Human Papillomavirus in the occurrence of abnormal PAP Smear and cervical cancer, and increase awareness of the population about this latent disease through promoting talks about cervical cancer and prevention of HPV infection. Even though cervical cancer is among the cancers that can be prevented, it is very important to continue screening tests and providing vaccination for protection. Nurses play an important role in the screening programs by providing educative talks and training mainly to high risk groups, with the purpose of increasing the awareness of the people about cervical cancer and HPV prevention. Furthermore, this research will serve as a reference for future research.

III. Cervical Cancer Background

Cervical cancer is a global health problem for all women because of the alarming number that has been a victim of this disease claiming many lives. For many decades, the cause of cervical cancer was unknown. It was not until the twentieth century that researchers found it that the disease was caused by exposure to human papillomavirus (HPV). Nowadays, vaccines against some forms of the virus are widely available.

Cervical cancer begins in the patient’s cervix. The portion of the uterus that it is exposed into the vagina and has a healthy pink color covering with squamous cells is called ectocervix, and the endocervix or cervical canal is called columnar cells. Where these cells merge is called the transformation zone (T-zone). This transformation zone is the location for abnormal or precancerous cells to develop (NCCC, 2016).

The disease has been known since many years ago. In 400 A.C., the Greek physician Hippocrates wrote about the disease and even tried to treat cancer with a procedure known as Trachelectomy o Cervicectomy, but he found nothing completely eradicated cancer. This procedure was used later for a brief period in the 1940s, it involves the removal of the cervix and direct linking the vaginal canal to the uterus.

In the 1980s, Zur Hausen and Gissmann provided the first solid documentation that specific Human Papillomavirus (HPV) types were linked to cervical cancer. More than 2000 years have passed since Hippocrates gave the first explanation about cervical cancer. Epidemiologists researching in the early 20th century recognized that cervical cancer was frequent in female sex workers and in women whose husbands had a high number of sexual partners or visited regularly prostitutes women, and also that this kind of cancer was rare in Jewish women (Panatto, 2008). Other important achievement in the prevention of cervical cancer were: the creation of the Colposcope in 1925, the development of the Pap technique by Papanicolaou, the launch of Pap screening by Papanicolaou and Traut and the development of a specific spatula to scrape the cervix by Ayre. Nevertheless, Zur Hausen and Gissmann in 1976 brought in HPV DNA in cervical cancer and warts (Panatto, 2008).

In 1983, Zur Hausen, Gissmann and their collaborators recognized HPV 16 in genital cancer lesions, and in 1985, they showed the presence of HPV DNA in cervical cancer cells. The discoveries created the primary steps for further studies leading to the development of two preventive vaccines: Gardasil® and Cervarix®. Both vaccines protect against cervical lesions caused by HPV 16 and 18. Furthermore, Gardasil® also defends against HPV 6 and 11. These genotypic are responsible for 90% of genital warts (Panatto, 2008). Investigations have been demonstrated that both vaccines are a powerful tool to fight mild and severe cervical lesions. Furthermore, both vaccines are safe and well tolerated by patient.

Nevertheless, important questions remain open, the establishment of the vaccines were an historic moment in medical science pointing a new beginning in cancer prevention.

Background of the Study

In 19th century Verona, Dr. Domenico Rigoni-Stern noticed that uterine cancer, while relatively frequent in women living in the city, was very infrequent in the Catholic religious woman who lived in the convents in the countryside. Further researches demonstrated a more conventional explanation: the risk of cervical cancer was linked with the number of sexual partners, prostitutes had a high risk of getting the disease, married women had a moderate risk, and religious woman were spared. This epidemiological frame strongly indicated that a sexually transmitted agent had an important piece in the development of cervical cancer (DiMaio, 2015). Researching the principal causes of cervical cancer took many years of investigations leading false results. Many infectious agents like syphilis, chlamydia, herpes simplex virus, and gonorrhea were falsely accused (DiMaio, 2015).

In the early 20th century, hunters in the Midwest observed and reported seeing rabbits with horns. Later, some of them were captured and sent it from Kansas to the Rockefeller Institute in New York City for investigation. The researchers isolated the cells and inoculated them in healthy rabbits. Thru out the microscopic, they could observe that these lesions were not horns at all if not keratinized warts or papillomas. The microscope also showed a large numbers of virus cells. Due to this investigation, the papillomavirus was discovered for the first time (DiMaio, 2015).

In early 1980, Papillomaviruses were first linked with cancer of the cervix. Harald Zur Hausen after unsuccessful experiments to prove a relation between herpes simplex virus type 2 and cervical cancer turned his studies to papillomaviruses. His first studies showed that the HPV types that cause plantar and common warts were not observed in cervical cancer. For those reasons, Zur Hausen looked for viruses that infect the genital area. He began studying HPV type 6. This type 6 is responsible of external genital warts, or condyloma. But, this virus was rarely present in cervical cancers. After several investigations, HPV types 16 and 18 were identified. 70 % of woman with cervical cancer contained HPV-16 or HPV-18 DN. Furthermore, he also concluded that HPV-negative cervical cancer was a diagnostic mistake (DiMaio, 2015).

These findings discoveries revolutionized the biomedical community. Very soon, they produced solid proof that HPV plays an essential role in the development of cervical cancer. The most solid evidence came from using the vaccines to prevent HPV infection (DiMaio, 2015). HPV vaccination potentially aims to diminish the morbidity and mortality rates from cervical cancer. Nevertheless, promoting Papanicolaou smear or PAP smear screening test, educating parents and children, and infection control measures are still important part to fight this malignancy (Greener, 2014).

Quantitative studies in United Stated indicated many factors linked with woman’s participation in cervical cancer screening among certain ethnic groups. In USA, Hispanic population have high incidence and mortality rates of cervical cancer. Qualitative investigations found many factors that constitute barriers for a Pap smear like cultural norms and beliefs, individual perceptions about cancer, language difficulties, limited knowledge about HPV, and cervical cancer (M Grandahl et al., 2015).

A British study indicated a reduce awareness of HPV and a reduce acceptability of the vaccine among ethnic minorities. Similar conclusions were recently found among woman from other countries with low income in the United States: Only 11% accepted HPV vaccination for their daughters. In those cases, lack of knowledge was the main problem. Parents wanted to have more information to make a decision about HPV vaccination. As a result of this quantitative study, the investigators concluded that: woman would like to participate in cervical cancer prevention programs and accept HPV vaccination for their daughters, but do not have enough knowledge about it, and have difficulties understanding all aspects of the program from primary care providers. Furthermore, even though the women were available and agree to participate in the prevention of cervical cancer, several obstacles were identified: language problems, reduce knowledge about the relation between sexual transmission of HPV and cervical cancer, and lack of regular health check-ups (M Grandahl et al., 2015).

IV. Methodology

Hypothesis

H- Human Papillomavirus affects the occurrence of abnormal PAP Smear and cervical cancer in women 21 to 65 years.

Definition of Terms

Cervical Cancer: is a type of cancer that develops in the cells of the cervix, more specifically in the lower part of the uterus that connects to the vagina (Staff, 2016). See appendix A.

Human Papillomavirus: it is the most frequent sexually transmitted infection (STI). There are many different types of HPV (FDA, 2016).

Pap Smear Test: it is performed to screen for cervical cancer. Cells are obtained from the cervix and are examined under a microscope (NIH, 2016). See appendix B.

Variables

Independent Variable: Human Papilloma Virus.

Dependent variable: Cervical Cancer.

Dependent variable: Abnormal PAP Smear

Type of Research

The investigation to be conducted will be an exempt study with the general objective of determining the influence of Human Papillomavirus in the occurrence of abnormal PAP Smear and Cervical Cancer in women aged 21 to 65 years.

This exempt study will involve medical records, existing data, documents and pathological samples. The source of information is not available to the general public so that the participants cannot be identified directly or through personal identifiers. All information related with the identity of the participants will be kept private and confidential and will be protected at all times.

Study Population

The population will be all women between 21 to 65 years meeting the following criteria:

Inclusion criteria:

1. Women between 21 and 65 years.

2. Sexually active.

3. Women with cervical cancer.

4. Woman with abnormal PAP Smear.

Exclusion criteria:

1. Women <21 years and > 65 years.

2. Woman not sexually active

3. Women without cervical cancer.

4. Women without abnormal PAP Smear.

Research Technique

The technique to be used will be review medical records in order to identify existing data about infections for Human Papilloma Virus associated with cervical cancer, identify numbers of sexual partners, HPV vaccination history, Abnormal PAP Smear history, and Papanicolaus screening, including HPV/cytology co-testing regular check-up.

All information related with the identity of the participants will be kept private and confidential and will be protected at all times.

V. Analysis of data

Data collected from the medical record will be processed in Microsoft Excel and Microsoft Word.

Microsoft Excel is a spreadsheet program used to keep and recovery numerical data in a framework format of columns and rows. Microsoft Excel will use to make a statistical analysis of the data obtained after processing the data from our source of investigation: medical records, existent data, and pathological samples. During the investigation, data related with the specific objectives of the study will be collected, and the numerical data will be stored in Microsoft Excel to identified the number of case where the Human Papillomavirus are present in abnormal PAP Smear and Cervical Cancer giving effect to our overall objective. Microsoft word will be used to process the information collected during the study in form of text.

VI. References Castellsagué, X. (2008, September). Natural history and epidemiology of HPV infection and cervical cancer. Retrieved October 1, 2016, from https://www.ncbi.nlm.nih.gov/pubmed/18760711 CDC. (2016, June 20). Gynecologic Cancers . Retrieved from Cervical Cancer Statistics: http://www.cdc.gov/cancer/cervical/statistics/index.htm DiMaio, D. (2015, June 1). Nuns, Warts, Viruses, and Cancer. Retrieved from Yale Journal of Biology and Medicine: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4445434/ FDA. (2016, May 23). HPV (human papillomavirus). Retrieved from U.S. Food and Drug Administration: http://www.fda.gov/ForConsumers/ByAudience/ForWomen/ucm118530.htm Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray, F. (2014). Worldwide data. Retrieved September 29, 2016, from WCRF International: http://www.wcrf.org/int/cancer-facts-figures/worldwide-data Greener, M. (2014, October 1). Tackling HPV and cervical cancer: Looking at the whole picture. Retrieved from https://eds.b.ebscohost.com/ehost/pdfviewer/pdfviewer?sid=79069509-7b48-411a-b497-e1acc2587037%40sessionmgr103&vid=8&hid=114 Maria Grandahl, Tanja Tyden, Maria Gottvall, Ragnar Westerling, Marie Oscarsson. (2015, June 1). Immigrant women’s experiences and views on the prevention of cervical cancer: a qualitative study. Retrieved from EBSCO: https://eds.a.ebscohost.com/ehost/detail/detail?vid=3&sid=7cf2c91b-5b3a-469a-9b5f-b9006e088df2%40sessionmgr4007&hid=4105&bdata=JnNpdGU9ZWhvc3QtbGl2ZQ%3d%3d#AN=103792250&db=c8h NCCC. (2016). National Cervical Cancer Coalition. Retrieved from Cervical Cancer Overview: http://www.nccc-online.org/hpvcervical-cancer/cervical-cancer-overview/ NIH. (2014, November 5). A Snapshot of Cervical Cancer. Retrieved from https://www.cancer.gov/research/progress/snapshots/cervical NIH. (2016, April 05). Retrieved from https://medlineplus.gov/ency/article/003911.htm Olusola Adegoke, Shalini Kulasingam, Beth Virnig. (2012, October 1). Cervical Cancer Trends in the United States: A 35-Year Population-Based Analysis. Retrieved from Journal of Women’s Health : https://eds.b.ebscohost.com/ehost/pdfviewer/pdfviewer?sid=62785b43-b934-464a-b3c6-c5df4254ba46%40sessionmgr102&vid=4&hid=113 Panatto, D. (2008). Cervical cancer: From Hippocrates through Rigoni-Stern to zur Hausen. Retrieved October 1, 2016, from http://www.hu.ufsc.br/projeto_hpv/Cervical%20cancer%20From%20Hippocrates%20through%20Rigoni-Stern%20to%20zur%20Hausen.pdf Society, A. C. (2016, January 29). What are the key statistics about cervical cancer? Retrieved from Cervical Cancer : http://www.cancer.org/cancer/cervicalcancer/detailedguide/cervical-cancer-key-statistics Staff, M. C. (2016). Cervical cancer. Retrieved from Mayo Clinic: http://www.mayoclinic.org/diseases-conditions/cervical-cancer/home/ovc-20210887

Appendix A

Pap test (2016) Retrieve from: http://www.mayoclinic.org/diseases-conditions/cervical-cancer/home/ovc-20210887

Appendix B

Pap test (2016) Retrieve from: https://medlineplus.gov/ency/article/003911.htm