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RESEARCH PROPOSAL APPLICATION FORM

Date of Receipt Protocol Number

1. Title of Proposal:
Effectiveness of breast self-examination among women, and nursing
responsibility in teaching breast self-examination.
2. Type of Project: (Please check all applicable options)

Chart Review Diagnostic PhD Project Qualitative Research

Human Laboratory Msc Project Quantitative Research

Therapeutic Basic Science Other _________________

3. Starting Date: 4. Duration: 5. Total Fund Requested (SR):


______________________ _____________________ ______________________________

6. Principal Investigator (PI):


Name: _______________________________ Tel. No.(W): _________ Mobile No.: ___________
Affiliation & Address: _______________________________________________________________
Title/Position: ___________________________ E-mail: _________________________________

7. Name of co- Investigators: (instructions: there is no limit to the number of co-investigators and their
expertise should cover the different research areas. )

Co-Investigators Title/Position Department Signature

8. Principal Investigator’s Assurance:


The undersigned agrees to accept responsibility for the scientific and technical
conduct of the proposed research and submission of progress reports if this
application is approved.

_____________________________ ________________________ _________________


Name of Principal Investigator Signature Date

DEPARTMENT APPROVAL:

_____________________________ ________________________ _________________


Name of Chairman Signature Date

9. Background: (Instructions: Literature review of previous studies on the subject; and justification of the
study by stating the problem and its importance)

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Operational definitions of variables
-Breast self-examination: monthly breast examination performed by women following the five main steps of breast self-examination,
including: examining both breasts for size, shape, color and contour while looking straight using the mirror while arm on the hips or
over the head. palpating or feeling the breast both standing and lying position using the pad of the three finger.
Operational
-Breast definitions
cancer: disease of variables
characterized by the growth of malignant cells in the mammary glands.
-There are different staging systems for breast cancer:
1- When the disease is localized to the milk ducts, this stage called *stage 0* of breast disease is (ductal carcinoma in situ).
2-*Stage I* breast cancer, with no affect in the lymph nodes, is less than 2 cm across and has not spread anywhere
3-Each of the following is breast cancer *stage II*:
The tumor is less than 2 cm large but has spread to the lymph nodes of the underarm (IIA).
The tumor is greater than 5 cm and has not spread under the arm to the lymph nodes (both IIB).
4-*stage |||*: Stage IV breast cancer is defined as a tumor that has spread to areas far from the breast, such as the bones, lungs,
liver, regardless of size.
Introduction
Breast cancer is a malignant cell growth in the breast most common disease that develops
around the world. If it is not treated, cancer will spread to other sites of the body. The risk of
getting the disease is related to increasing age. Moreover, the incidences of breast cancer
rise at the age of 50 or more mainly occur in women. Furthermore, early detection of breast
cancer may decrease the opportunities from being vulnerable also it’s more likely to be
treated successfully. Researches believes that performing breast self-exam in combination
with other screening methods can increase the odds of early detection. It is the simplest
procedure that can do after menstrual period. In addition, mammography distinguishes the
earliest stage of breast cancer before cancer development and spread throughout the body.

Literature review
Breast Cancer Literature Review Ayed et al., (2015) explore breast cancer self-examination which remains a simple,
low-cost, and noninvasive method as an effective diagnostic approach to breast cancer diagnostic procedure among
Arab American students. The research employed a cross-sectional study from female nurses and allied medical
departments through social demographics and knowledge levels in Arab American students. The authors
acknowledge breast cancer as one cause of cancer-related deaths globally.
According to Dündar et al., (2006), breast cancer remains a disease for both developing and developed countries,
and among Turkish women, breast cancer constitutes the second most leading death cause. The authors in this
research paper explore the knowledge levels about breast cancer and health believes concerning the model that
promotes breast self-examination and mammography among young people in Turkey. The approach uses cluster
sampling among women.
Alomair et al., (2020) acknowledges breast cancer as the most common of all cancers among Saudi Arabia female
cancers and aims to explore exposure and knowledge about breast cancer among Saudi female students at King
Saud University. The research also acknowledges that cancer kills more than 500000 people women globally and
most women in resource-depilated states are diagnosed at an advanced stage. The research employs a cross-
sectional study among female students at King Saud University. The research showed that the majority of the people
in the university had moderate knowledge about breast cancer. The research established mass media as a source of
information about breast cancer and other health information.
Sapkota, Parajuli & Kafle, (2016) explores the effectiveness of the educational intervention approach in fighting the
Rationale
breast cancer menace that poses a great health challenge to women globally. The research follows a pretest and
post-test design adopted involving 61 girls and applies descriptive and inferential statistics. The research observed
that a greater percentage of women can detect breast cancer and the method was less harmful and can be
performed on any woman.
Rationale
The role of breast self-examination (BSE) is detecting early breast cancer. Also, it allows
women to examine their breast tissue for any physical or visual issues while performing the
palpation techniques and assessment then comparing both breast.

Significance
Breast self examination is mandatory step to encourage women to be actively
responsible for their own health, especially women older than 65 years of age also
women who live with limited resources and low income.Breast cancer considered the
most common cancer among Saudi population in the rate of (8.8%). There was a
significant difference between overall knowledge and practice of Breast self-examination
(BSE) which most of the studies have shown (15.5%) of the respondents had good
overall knowledge and (4.1%) practices Breast self-examination (BSE). Therefore the
responsibility falls upon nurses to use appropriate techniques and provide resources that
help to educate the patient.
Hypothesis
1- the relationship between knowledge towards BSE and practice of BSE.
2-Causal hypothesis: Practice Breast self-examination will cause early detection of
breast cancer. 2
10. Objectives of the Study:

10.1 Aim of the Study: (Instructions: state the goal you need to achieve)
1-determine the effectiveness of breast self examination among women.

2-Studay of women’s awareness of breast self examination and what are the best
management.

3-Understand the importance of nursing responsibility in teaching women about the


breast self examination.
10.2 Specific Objectives: (Instructions: state the details of each objective that will finally lead to achievement
of the goal)

1-The
1.
effectiveness of breast self examination to help and protect women from
breast cancer and provide chance to stay for a long life.
2.
2- It’s important to check awareness of women through screening and manage it
by
3. surgery, chemotherapy, radiotherapy, endocrine hormone therapy and targeted
therapy .
4.
3-
5. One of the most important nurse responsibilities is to teach the patient about
BSE for early detection of breast cancer.

10.3 Secondary Objectives: (Instructions: these are subsidiary objectives that could be studied during the
course of the project but are not the main objectives of the study, they are optional and vary according to
the type of the study)
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11. Materials and Methods: (Instructions: Describe the research methods that could best achieve the study
objectives, recommend to attached flow charts)

11.1 Study Area/Setting: (Instructions: describe the area or setting where the study will be conducted. This
description should cover the details relevant to the study topic)

The research will be focusing at National guard hospital which is localized at Kingdom of Saudi
Arabia, specifically in Al-Ahsa region. It aims to achieve higher education and provides the health
practitioner by maintaining special care and follow-up of the patients. The medical education
(WFME) is used to obtain high quality care. Furthermore, the duration of program is 6 years
approximately about 23 to 33 contact hours per week. Also, it contributes to promote the importance
of breast cancer and talks about the best devices for early detection of breast cancer. Moreover,
there are many volunteers to teach and educate about self-examination for breast cancer. Ensure
that health care providers do not discriminate on gender, religion, economic, social, or sexual status.

11.2 Study Subjects: (Instructions: Inclusion and exclusion criteria of the study subjects)

Inclusion criteria:
In the study, sampling criteria may include female subjects who visit women’s
clinical in King Adbulaziz hospital in Alhasa.
At age 45 or above( adult) with special circumstances such as breast problems
and family history of breast cancer.

Exclusion criteria:
Pregnant women, women who younger than 45 years old, a women with
immune diseases will exclude from the study.
11.3 Study Design: (Instructions: mention the type of study design eg cross-sectional, case- control,
intervention study, etc..)

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Design:
Cross sectional retrospective design was conduct to describe effectiveness of BSE
toward breast cancer women at a clinical in king Abdulaziz hospital in Alhasa.

11.4 Sample Size: (Instructions: mention the input criteria for sample size estimation.)
Sample size will be calculated using G power program and according to the
calculations:
Confidence level: 95%
Population size:150000
Margin of error:5%
Ideal sample size:384
It give an effective sample size that suit the inclusion criteria.
11.5 Sampling Technique: (Instructions: mention the sampling technique, (e.g. randomization) that
will be used in order to obtain a representative sample for your target population.)

The sample was selected by convenience sampling technique, and all the
samples were meeting the eligibility criteria that selected for the study .

11.6 Data Collection methods, instruments used, measurements (Instructions: Describe the instruments
used for data collection (questionaire, observation recording from, etc.), and studied variables included in these instruments,
as well as the methods used to test for the validity and reliability of the instrument. Techniques used should be briefly
described and referenced. Study definitions [e.g., case definition] should be mentioned.

In this study, a questionnaire is used to gather beneficial and relevant information.


11.6 Data Collection methods, instruments used, measurements (Instructions: Describe the
The questionnaire can be described as a self-administration survey consist of
instruments used for data collection (questionaire, observation recording from, etc.), and studied
multiple
variables questions
included inthat are
these answeredasbywell
instruments, participants through
as the methods used providing a particular
to test for the validity and
response to the listed question. This technique more comfortable and confidential
reliability of the instrument. Techniques used should be briefly described and referenced. Study
than the face-to-face
definitions interview,
[e.g., case definition] or telephone
should surveys. This questionnaire was
be mentioned.
distributed to 384 females admitted to the women’s clinic in King Abdulaziz hospital
in Al-hasa to determine the effectiveness of breast self-examination in the early
detection of breast cancer. Moreover, it's a helpful strategy to decide the extent of
women's awareness of the importance of breast self-examination and the proper
way to perform it. Also, the regular time to conduct self-breast screening either
monthly or annually.In this study we will check the data reliability and validity after
collecting data using alpha results is 0.9 .It’s compliad from literature Pınar Erbay
Dündar , it used reliability reported. The number of questions is 7. Moreover, The
target group in this study include female subjects who visit women’s clinical in king
Abdulaziz hospital in Alhsa. AAt the age of 45 or above( adult ). With special
circumstances such as breast problems, family history of breast, cancer .

11.7 Data Management and Analysis Plan: (Instruction: Describe the analysis plan, tests used for
data analysis and statistical package(s) used)
The data were enter and analyzed using the SPSS(Statistical Package for Social
Science). The level of significant (α) was set at 0.05. Descriptive and inferential
statistical tests were used.Hypothesis were tested and analyzed by using t-test.
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12. Bibliographic References: (Instructions: mention recent articles relevant to the study subject
and enumerated accroding to their order of appearance in the text)

1- Abdullah Nasser Alomair et al, 2020;4(2):429–434. International Journal of Medicine in


Developing Countries, from https://ijmdc.com/fulltext/51-1576668182.pdf?1613138002

2- Alomair, A. N., Felemban, D. G. M., Felemban, M. S., Awadain, J. A., Altowargi, A. S. J., &
Alfawzan, N. F. (2020). Knowledge, attitude and practice of breast self-examination toward
breast cancer among female students at king Saud University in Riyadh, Saudi Arabia. EC
Gynaecology, 9(1), 01-08. http://ijmdc.com/fulltext/51-1576668182.pdf

3- Breast Self-Examination in Terms of Knowledge, Attitude, and Practice among Nursing


Students of Arab American University/ Jenin, from https://www.researchgate.net/publication/
280681036_Breast_Self-
Examination_in_Terms_of_Knowledge_Attitude_and_Practice_among_Nursing_Students_o
f_Arab_American_University_Jenin

4- Dündar, P., Özmen, D., Öztürk, B., Haspolat, G., Akyıldız, F., Çoban, S. and Çakıroğlu,
G., 2021. The knowledge and attitudes of breast self-examination and mammography in a
group of women in a rural area in western Turkey, from https://link.springer.com/content/pdf/
10.1186/1471-2407-6-43.pdf

5- Sapkota, D., Parajuli, P. and Kafle, T., 2021. Effectiveness of Educational Intervention
Programme on Knowledge Regarding Breast Self Examination Among Higher Secondary
School Girls of Biratnagar, from https://www.nepjol.info/index.php/bjhs/article/download/
17091/13896

13. Ethical Considerations: Informed Consent (Instructions: If needed, please attach Informed
Consent and/or extra documents. Translated forms are provided when needed.)

Ethics approval and consent to participate


The study conforms to the code of ethics of the World Medical Association. To
ensure confidentiality, all data were anonymised before analysis. Before the
respondents started to answer the questions posed in the study, they declared
their willingness to participate in the study. Acceptance was provided online. All
female subjects who visit women’s clinical in King Abdulaziz hospital in al Ahsa
have received both verbal and written information about the study and signed an
informed consent form.

14. Workplan: (Instructions: Please use this form as a template for the timeline of your project)

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16. Budget (Please use the attached documents for the price list of equipments used in the
project if applicable)

Task
MONTH

1 2 3 4 5 6 7 8 9 10 11 12

1-survey of the
subject area
2-Handing out
questions
3-request for
interview
4-interview

Progress report

1-collections of
dated
2-data analysis
3-data
representation

15. Other Funding Agency

Does this study need fund? Yes [ ] No [ ]


Is your study funded by another funding agency? Yes [ ] No [ ]
(If yes, specify the agency and available funds)

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Budget Breakdown Unit Cost Total Remarks
(SR) (SR)
Personnel *

Total
Supplies and Equipment

Total
Patients Cost

Total
Others (please, specify and justify
briefly)

Total
GRAND TOTAL

 Funds allocated to all personnel should not exceed 30% of the total budget,
otherwise justification letter should be included

 Unit cost of each task should be accurately given to allow propoer budget
evaluation.

17. Appendices: (Instructions: Data collection instruments, elaboration on methods and procedures
to be used, etc.) (Please attach the related documents)

Documents are in next page.


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We are interested in things about your health. Please answer all of the
questions by yourself by put a mark inside the square that best applies
to you. There are “yes” or "no" or “don’t know” answers. Remember the
information that you provide will remain confidential from others.

Gender: Male Female

Marital status: Single Married

Age: <20 20-30 31-40 >40


Menstrua: Regular Irregular

Yes No I don’t know


1 Have you ever used a
contraceptives device?
Have you undergone
2 before to periodic
mammograms?

3 Do you have a family


history of breast cancer?
Have you ever heard
4 about the clinica breast-
self examination?

Can early detection of


5 breast cancer improve
the chance of surviving?

6 Have you perform Brest


self-examination before?

7 Did you expose to


radiation before?

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