الفهرس 
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Abstract
Summary
Breast cancer is a disease in which cells in the breast grow out of control. There are different kinds of breast cancer. The kind of breast cancer depends on which cells in the breast turn into cancer. Among women breast cancer is the most common malignant disease worldwide, accounting for 24% of new cancer cases and 15% of cancer deaths in 2018 and incident cases are expected to increase by more than 46% by 2040, according to the globocan Cancer Tomorrow prediction tool (Heer et al., 2020).
Breast cancer can be treated adjuvant with radiotherapy, chemotherapy, surgery, or hormonal therapy, depending on multiple factors such as genetic mutation, cancer stage, and metastatic status. About three-quarters of all patients diagnosed with breast cancers are estrogen receptor-positive and progesterone receptor-positive consequently; most patients are offered hormonal therapy for five to 10 years (Khobrani et al., 2022).
Hormonal therapy is associated with positive outcomes leading to lower rates of disease recurrence, metastasis and decrease mortality rates, and disease-free survival. According to National Comprehensive Cancer Network, hormonal therapy is considered a standard of care in the treatment of women with hormone receptor-positive breast cancer (Khobrani et al., 2022).
Adherence is a measure of how well the patient takes the medication compared with the instructions given by the clinician. While, non-adherence is defined as the failure to take medications as prescribed. Recent reviews of global studies have identified several factors that are associated with non-adherence to adjuvant hormonal therapy. These factors include personal demographic factors, side-effects, quality of life; knowledge of cancer, forgetfulness, beliefs, depressive symptoms, self-efficacy, structural health-system factor (healthcare provider relationship) and social support (Fadelu et al., 2022).
Aim of the study:
This study aimed to:
Assess adherence to adjuvant hormonal therapy among women with breast cancer
Through the following:
1. Assess women’s knowledge regarding hormonal therapy Action and side effect.
2. Assess Adherence to adjuvant hormonal therapy among women with breast cancer.
3. Assessment of factors affecting adherence to adjuvant hormonal therapy among women with breast cancer.
Research Questions:
This study will answer the following question
Q1- Are the woman with breast cancer adhere to hormonal therapy?
Q2- What are the factors affecting adherance to adjuvant hormonal therapy among women with breast cancer?
Subjects and methods
Research Design:
A descriptive design will be used to achieve the aim of this study.
Setting:
The study was conducted in the outpatient breast clinic at Oncology Center and Nuclear Medicine affiliated to Ain Shams University Hospitals, it was on the ground floor and it consisted of two rooms, one room contained a bed, an office, three chairs and a bathroom and the another room contained two offices, a bed with curtain, six chairs and weight and height measurement scales. The outpatient breast clinic received women daily except Monday and Tuesday.
Subjects:
Based on retrospective statistical data, the number of women with breast cancer that admitted to the oncology and nuclear medicine center affiliated to Ain Shams University Hospitals during the year 2019 and received adjuvant hormonal therapy was 450 women, so a purposive representative sample were be 60 women.
Tools of data collection:
The data was collected using the following tools:
І- Structured Interview Questionnaire for Women with Breast Cancer receiving Hormonal Therapy:
It was developed by the researcher in Arabic language after reviewing the recent related literatures and it includes the following parts:
Part 1: Socio-Demographic data of women with breast cancer:
It was used to assess women’s socio demographic characteristics.
Part 2: Medical Health Profile of Women with Breast Cancer:
It was used to collect data about women’s history which include present medical history of the disease, hormonal therapy history, past history, child birth and menstrual history, surgical history, treatment history and family health history,.
Part 3: Women’s Knowledge Regarding Breast Cancer and Hormonal Therapy:
This part was developed by the researcher based on review of relevant literature El-Feqi et al., (2020), Alomeir et al., (2020), American Cancer Society, (2015), Timby et al., (2014) it included 22 item to assess women knowledge regarding breast cancer and hormonal therapy.
2-The Morisky Medication Adherence Scale (MMAS-8):
This tool was adopted from Morisky et al., (1986) to assess medication adherence of patient with breast cancer receiving hormonal therapy.
3-Factors Affecting Adherence to Adjuvant Hormonal Therapy among Women with Breast Cancer:
It included the following parts:
1) Treatment Related Factors:
- The Breast Cancer Prevention Trial Symptom Checklist:
This tool was adopted from (Cella et al., 2008). It measure a list of 42 cognitive and physical symptoms associated with the treatment divided into 6 items cognitive and 36 items physical.
2) Patient Related Factors:
Pain interference: Brief Pain Inventory (BPI)-Interference subscale, This tool adopted from (Cleeland, 1989). measures how much pain has interfered with 7 daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep.
Depression: center for epidemiologic studies depression CES-D Scale, This tool adopted from (Radloff, 1977(. self-reported depression scale includes 20-items regarding depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, and sleep disturbance.
Self-efficacy: (CASE)–Communication and Attitudinal Self Efficacy, This tool was adopted from (Wolf et al., 2005). 19-item Cancer scale was used in this study, to assesses 3 domains: understanding and participating in care, maintaining positive attitude, seeking and obtaining information.
Fatigue interference: 12-items Fatigue Symptom Inventory (FSI)- this tool was adopted from (Hann et al., 1998). measures how much fatigue has interfered with general activity, ability to bathe and dress oneself, normal work activity, ability to concentrate, relations with others, enjoyment of life, and mood.
Perceived stress: The 10-items Perceived Stress Scale, this tool adopted from (Cohen et al., 1983). It used to measure perception of stress and the degree to which situations in one’s life are appraised as stressful.
Social support: The 19-items MOS-Social Support Questionnaire, this tool was adopted from (Sherbourne, 1991). Measured 4 types of social support: emotional/ informational support, tangible support, affectionate support, and positive social interactions.
Operational Design
The operational design for this study consisted of four phases, namely preparatory phase, ethical considerations, pilot study, and fieldwork.
A. Preparatory Phase
It includes reviewing of related literature and theoretical knowledge of various aspects of the study using books, articles, internet, periodicals and magazines.
Testing Validity and reliability:
Testing validity (referred to how well a scientific test actually measures what it is intended to measure) of the proposed tools by using face and content validity. Face validity aimed to inspecting the items to determine whether the tools measure what supposed to measure. Content validity was conducted to determine whether the content of the tools cover the aim of the study (Lobiondo-wood & Haber, 2017). Validity tested by a jury of 7 experts, two of them were professor, two were assistant professor, and one lecturer from medical surgical nursing department at faculty of nursing, Ain shams university and two medical consultant of the oncology department at Ain Shams University Hospitals. The experts reviewed the tools for clarity, relevance, comprehensiveness, simplicity and applicability, minor modification was done. Finally the final forms were developed.
Testing reliability: it was referred to the extent to which the same answers can be obtained by using the same instruments more than one time (Grove et al., 2014); Testing reliability of the proposed tools was done statistically by Cronbach alpha test. Alpha Cronbach’s: is a measure of internal consistency, that is how closely related to asset items are as a group.
- Cronbach alpha for knowledge about breast cancer and hormonal therapy was 0.834.
- Cronbach alpha for medication adherence scale was 0.804.
- Cronbach alpha for Factors affecting women adherence to hormonal therapy was 0.810.
Pilot Study:
A pilot study will carried out on (10%) of total number of women’s to ensure the feasibility, clarity, applicability of tools and time needed to fill the tools after analyzing the results of the pilot study needed modifications will be done accordingly, and refinement of the tools will full filled.
Field work:
The collection of data lasted over a Period of 7 months; starting from April 2021 and ending in October 2021.
The researcher visited the Outpatient breast clinic two days a week. Sunday and Wednesday during morning shifts (9.00 am to 2.00 pm), meeting about 1- 2 women each time.
The women who fulfilled the inclusion criteria were selected.
The interview questionnaires were conducted with each woman individually.
The researcher obtained the women’s oral consent for participating in this study after explaining the aim of the Study.
Filling in the previously mentioned Tools was done by the researcher.
First socio-demographic and medical health profile were collected from the women’s medical records, from the women themselves and relatives. Then the researcher asks about women’s knowledge regarding breast cancer and hormonal therapy, adherence level to medication and factors affecting adherence to adjuvant hormonal therapy.
These tools were completed within an average time from 70-90 minutes.
Administrative design:
Approval to carry out this study will be obtained from the Dean of faculty of nursing and director of oncology department at Ain-Shams University in which the study will be conducted.
Ethical consideration:
The ethical research considerations in this study include the following:
• A written approval will be obtained from scientific research ethical committee in faculty of nursing at Ain Shams University before starting the study.
• The researcher will clarify the objective and aim of the study to the women’s who have breast cancer and included in the study.
• The researcher will assure maintaining anonymity of the subjects` data of the women’s included in the study.
• Women’s will be informed that they are allowed to choose to participate or not in the study and all information will be confidential and used only for research purpose.
Result of the study:
The important findings that were obtained from the study can be summarized as follows:
• Regarding Socio-demographic characteristics of the studied women, 43.3% of the studied women their age was ≥ 50 years with mean of 46.3 ± 11.58 years. As regard to marital status, 80% of them were married. Also, 56.7% of them residing at rural areas and housewives, respectively. Moreover, 60% of the studied women treated for free of charge. Likewise, 96.7% of them were not smokers. Also, 55% of the studied women had 4 family members and more.
• Regarding education, 60% of the studied women had diploma / secondary education. Also, 16.7% of them had high education.
• Regarding income, 83.3% of the studied women had insufficient income to cover the costs of treatment. While, 16.7% of them had sufficient income to cover the costs of treatment.
• Regarding present medical and hormonal therapy history, 53.3% of the studied women had mastectomy 2-< 4 years, with Mean SD 3.12 ± 1.2 years. Moreover, 91.7% of them suffered from fatigue and hot flashes on the face, respectively. 55% of the studied women started hormonal therapy 2-< 4 years, with Mean SD 4.1±1.08 years. Also, 100% of them take the drug orally. Moreover, 90% & 100% of them take aromatase one time per day.
• Regarding total knowledge, 63.6% of the studied women had unsatisfactory level of total knowledge about breast cancer and hormonal therapy. While, 36.7% of them had satisfactory level.
• Regarding total adherence, 40% of the studied women had high level of medication adherence. Also, 33.3% of them had moderate level. While, 26.7% of them had low level. The Mean±SD of total medication adherence was 3.2±1.23.
• Regarding to total cognitive and physical symptom, 70% of the studied women had sever physical and cognitive symptoms. Also, 20% of them had moderate symptoms, while 10% of them had low symptoms.
• Regarding to pain level, 66.7% of the studied women had sever pain. Also, 20% of them had moderate pain, while 13.3% of them had mild pain.
• Regarding to total depression level, shows that 50% of the studied women had sever depression. Also, 38.3 %of them had moderate depression, while 11.7% of them had mild depression.
• Regarding to total self-efficacy, 50% of the studied women had low self-efficacy. Also, 33.3% of them had high self-efficacy, while 16.7% of them had moderate self-efficacy.
• Regarding to total fatigue, 71.7% of the studied women’s had sever fatigue symptoms. Also, 18.3% of them had moderate fatigue, while 10% of them had mild fatigue.
• Regarding to total level of stress, 68.3% of the studied women had high of stress. Also, 26.7% of them had moderate stress, while 5% of them had low stress.
• Regarding to total level of social support, 71.7% of the studied women’s had high level of social support. Also, 20% of them had moderate level, while 8.3% of them had low level.
• Regarding to Correlation between studied variables, there was highly statistically positive correlation between knowledge with medication adherence, social support, self-efficacy, and medication adherence of women with breast cancer. Also, there was highly significant negative correlation between physical and cognitive symptoms, pain, depression, fatigue, stress and medication adherence of women with breast cancer receiving hormonal therapy among studied sample.
Conclusion
Based on the findings of this study it can be concluded that the research question was answered as:
Near two thirds of women had unsatisfactory level of total knowledge about breast cancer and hormonal therapy. While, less than half of them had high level of medication adherence. Regarding factors that affecting adherence to adjuvant hormonal therapy, the Study had identified several factors that are associated with non-adherence to adjuvant endocrine therapy; these factors include side-effects of treatment especially musculoskeletal pain, fatigue, knowledge of cancer, forgetfulness, beliefs, depressive symptoms, attitudes and self-efficacy. there was significant negative correlation between total physical and psychological symptoms, pain, depression, fatigue, stress, and medication adherence of women with breast cancer receiving hormonal therapy among studied sample at (P=<0.01).
Recommendations
Based on the findings of the present study, the following recommendations are suggested:
1. Educational programs and motivational interviewing should be planned about successful result of hormonal therapy to encourage women adherence toward medication.
2. Women are in need of a simplified and comprehensive Arabic booklet including information about action, side effect and best effective period for medication. Also rely that the effectiveness of treatment depends on the efficacy of the medication and patient adherence to the therapeutic regimen.
3. Working toward increasing women awareness and screening for breast cancer at regular intervals among high risk groups is paramount to recognize breast cancer disease at early stage before the progresses and metastatic to another organ.
4. Follow up care for women with breast cancer through phone calls, internet and clinical visits by trained oncology nurses at breast cancer clinics should be added to the care of those women.
5. Replication of the current study on a larger probability sample is recommended to achieve generalization of the results and wider utilization of the designed instructions.
6. Importance of all health care providers namely the nurses to take into consideration all the studied factors affecting women adherence for hormonal therapy in planning and managing care for such group of women.
7. The establishment of special centers in different governorates of Egypt especially rural area to promote and integrate care follow up, teaching for breast cancer women