Iraqi J Pharm Sci, Vol.30(Suppl.) 2021 Adherence &beliefs of breast cancer patients DOI : https://doi.org/10.31351/vol30issSuppl.pp31-39 31 Adherence and Beliefs to Adjuvant Hormonal Therapy in Patients with Breast Cancer: A Cross-Sectional Study (Conference Paper )# Anwar H. Saad*,1, Ihsan S. Rabeea**and Haider N. Salih*** # 9th scientific conference conference sponsored by College of Pharmacy , University of Baghdad 25-26 August 2021 *Kufa Technical Institute, Al-Furat Al-Awsat Technical University, Najaf, Iraq **Faculty of Pharmacy, University of Kufa, Najaf, Iraq ***Middle Euphrates Cancer Center, Najaf, Iraq Abstract Breast cancer is the most common cancer among women over the world. To reduce reoccurrence and mortality rates, adjuvant hormonal therapy (AHT) is used for a long period. The major barrier to the effectiveness of the treatment is adherence. Adherence to medicines among patients is challenging. Patient beliefs in medications can be positively or negatively correlated to adherence. The aims of the study were to investigate the extent of adherence and factors affecting adherence, as well as to investigate the association between beliefs and adherence in women with breast cancer taking AHT. The method was a cross-sectional study included 124 Iraqi women with breast cancer recruited from Middle Euphrates Cancer Center. Morisky medication adherence scale (MMAS) and beliefs about medication questionnaires (BMQ) are used to assess adherence and beliefs respectively. As a result, 25% of women were fully adherent (MMAS = 8). 83.06% of all women developed side effects from medications received. Side effects and unemployment state were significantly associated with non- adherence. Additionally, there is no significant association between beliefs in medications and adherence. The conclusion of the study was that high percent of poor adherence caused by side effects suggests the need for interventions by educating patients about the importance of their treatment and how to overcome side effects. Keywords: Adherence, Beliefs, Breast cancer, adjuvant hormonal therapy. مقطعية دراسة: الثدي سرطان مرضى لدى المساعد الهرموني بالعالج والمعتقدات االلتزام #) بحث مؤتمر ( *** صالح نعمان حيدر و ** صالح ربيع إحسان ، 1*، حبيب سعد أنوار 2021اب 26 – 25جامعة بغداد ، # المؤتمر العلمي التاسع لكلية الصيدلة .العراق ، النجف ، التقنية األوسط الفرات جامعة ، التقني الكوفة معهد* .العراق النجف، الكوفة، جامعة الصيدلة، كلية** .العراق ، النجف ، األوسط الفرات سرطان مركز *** الخالصة استخدام العالج سرطان الثدي هو أكثر أنواع السرطانات شيوعاً بين النساء حول العالم. لتقليل عودة السرطان ومعدل الوفيات، يتم كما يمكن أن الهرموني المساعد لفترة طويلة. العائق الرئيسي لفعالية العالج هو االلتزام بالعالج حيث يمثل االلتزام باألدوية بين المرضى تحديًا. م النساء باألدوية ومعرفة العوامل المؤثرة ترتبط معتقدات المريض باألدوية ارتباًطا ايجابياً أو سلبيًا بااللتزام. الهدف من الدراسة هو قياس مدى التزا هرموني على التزامهن، باإلضافة إلى قياس مدى االرتباط بين المعتقدات وااللتزام لدى النساء المصابات بسرطان الثدي الالتي يتلقين العالج ال ية مصابة بسرطان الثدي حيث استخدم مقياس امرأة عراق 124المساعد. أقيمت الدراسة في مركز الفرات األوسط لألورام السرطانية وشملت ( من %83,06٪ من النساء ملتزمات تماماً، ) 25لتقييم االلتزام والمعتقدات على التوالي. النتيجة: كان مورسكي ومقياس المعتقدات حول الدواء حالة انعدام العمل بشكل كبير مع عدم االلتزام باألدوية جميع النساء ظهرت عليهن آثار جانبية من األدوية التي تم تلقيها. ارتبطت اآلثار الجانبية و ر الجانبية إلى الحاجة بينما ال توجد عالقة ذات داللة إحصائية بين المعتقدات في األدوية وااللتزام. تشير النسبة العالية من قلة االلتزام الناجم عن اآلثا على اآلثار الجانبية. إلى دراسات تثقيفية للمرضى حول أهمية عالجهم وكيفية التغلب الكلمات المفتاحية: االلتزام، المعتقدات، سرطان الثدي، العالج الهرموني المساعد. Introduction Breast cancer is the most common cancer among women over the world in 2020 and accounting for 24.5% of all cancer cases worldwide while it is accounting 24% of overall malignancies in Iraq (1). Approximately two-thirds of all breast cancer cases have hormone receptor-positive breast cancer [estrogen receptors positive (ER+) or estrogen receptors positive plus progesterone receptors positive (ER+ plus PR+)]. After primary treatment (surgery, radiation, and chemotherapy), adjuvant hormonal therapy (AHT) is a standard therapy prescribed for most hormone receptor- positive breast cancer. The most common two types of AHT used are selective estrogen receptor modulators (SERM) such as tamoxifen and aromatase inhibitors (AI) that inhibit estrogen production such as anastrozole (2). The use of any type depends on the menopause state of the woman. Guidelines recommended the use of tamoxifen for 5 years in premenopausal women while AI is the recommended type in postmenopausal women as 1Corresponding author E-mail: anwar.habeebsaad@gmail.com Received: 24/8/2021 Accepted:15 / 11/2021 Published Online First: 2022-1-12 Iraqi Journal of Pharmaceutical Science https://doi.org/10.31351/vol30issSuppl.pp31-39 Iraqi J Pharm Sci, Vol.30(Suppl.) 2021 Adherence &beliefs of breast cancer patients 32 primary or extended after using tamoxifen for 5 years and sometimes it is recommended to use AI as sequential (a combination with tamoxifen for 3 years followed by 2 years of AI) (3). Long-term management by AHT for five years or more is highly effective in reducing recurrence, mortality rates and improve overall survival (4,5). However, to obtain these benefits, women should take medication as prescribed. Studies found that adherence to AHT was suboptimal, only 50% of women with breast cancer were adherent to AHT and about two-third discontinued AHT before completing recommended period (6,7). A systematic review of psychosocial motivators and barriers of adherence to oral anticancer used in breast cancer revealed that the barriers of adherence are patients feeling discomfort toward taking AHT, concerns about side effects of AI such as joint pain and gynecological symptoms while good beliefs about medication and good patient-physician relationship are positively correlated with adherence (8). The non- adherence is also associated with sociodemographic factors such as younger or older age (less than 40 and more than70), ethnicity, unmarried women, and those with lower income (9). Many studies measured adherence for chronic disease in the Arabic population but few of them focusing on the association between beliefs and adherence in breast cancer survival (10–12). Therefore, this study aims to investigate the extent of adherence among the breast cancer population, predictors for non-adherence, as well as to investigate the association between beliefs and adherence in women with breast cancer. Method Study design and subjects A cross-sectional study was conducted among 124 women recruited from Middle Euphrates Cancer Center\Najaf governorate\ Iraq from the 15th November 2020 to the 30th April 2021. The study was approved by the Scientific Committee of Researches of Najaf Health Department (reference number 30599). Women were eligible to participate if they were aged ≥ 18, diagnosed with breast cancer, taking tamoxifen or anastrozole for at least one month, and completed all primary treatment (surgery, radiation, and chemotherapy). We excluded women who have metastatic breast cancer and receiving chemotherapy, have a history of recurrence, and women with a psychological problem. Tools Sociodemographic and clinical variables were collected from patients including age, marital status, income categorized as following: good income >1,000,000 IQD; medium income 500,000- 1,000,000 IQD and; poor income <500,000 IQD (13), smoking, years since diagnosis, type of AHT used, drug side effects, and others summarized in (table 1). Medication adherence The assessment of adherence was done by using the Morisky medication adherence scale (MMAS) (14). It is a validated 8 items scale from previously published 4-items MMAS-4 (15). MMAS- 8 that used in this study was a copy of MMAS-8 used in the previous study (16). This scale includes 8 items, where the first seven questions are answered by yes or no and the eighth one is a five Likert scale answered either by never/rarely, once in a while, sometimes, usually, and all the time. The score of MMAS ranged from 0 to 8 and in this study scores < 6 were considered to be poor adherence, scores ≥ 6 - < 8 represent medium adherence, and scores = 8 represent high adherence. Women with poor or medium adherence are considered non-adherent (17). Medication beliefs Women's beliefs about AHT are measured by the beliefs about medication (BMQ) scale which is widely used in chronic disease (18). BMQ proven to be used in women taking AHT (19). The validated Arabic version with proven validity and reliability is used in a previous study (20). The scale consists of 18 items included in two sections which are either general or specific. Specific-BMQ (questions specific for AHT medications) has two 5-item subscales, the specific-necessity subscale to assess the necessity of the prescribed AHT medication and the specific-concern subscale to assess concern about the negative effect of prescribed AHT medication. General-BMQ (questions about medicines in general) has 8 items also subdivided into two 4-item subscales, general-harm that to assess the beliefs about the harmful effect of the any medication and general-overuse to assess beliefs of medication overuse by doctors. Each item is a five- point Likert scale (strongly disagree, disagree, uncertain, agree, and strongly agree to have a score of 1, 2, 3, 4, and 5 respectively). Answers are recorded and a high score (agree and strongly agree answers) indicates stronger beliefs in the concepts of each subscale. Procedure Face-to-face interview was chosen because it is the most effective way of capturing a wide range of perspectives and allow interviewers to explore deeply for responses and clarify any ambiguity. Furthermore, during the interview, patients' sensitive topics concerning their daily and social lives can be discussed, making participants feel more comfortable providing this information privately in a one-to-one setting and when compared to telephone interviews or self-reporting questionnaires, face-to-face interviews are known to have a greater response rate (21). Women who visited Middle Euphrates Cancer Center to refill the prescription were asked to participate in the study. Iraqi J Pharm Sci, Vol.30(Suppl.) 2021 Adherence &beliefs of breast cancer patients 33 After informed consent was taken from women, face-to-face interview by the researcher with each woman for about 20 min. Firstly, sociodemographic data and clinical information were taken from patients. Accordingly, MMAS and BMQ questionnaires were filled. Data analysis The results were analyzed by using a statistical package for social sciences (SPSS) version 23. Descriptive analysis was expressed as mean ± standard deviation (SD) and median (lower- upper quartiles [Q1-Q3]). Categorical variables were represented as numbers and percentages. Correlation between adherence levels and demographic and clinical data was analyzed by Chi- square test for categorical variables, while unpaired t-test for continuous normally distributed variables and Mann Whitney test for continuous non-normal distributed variables were used to compare between groups. Mann-Whitney test and Wilcoxon Z score were used for an association between BMQ and adherence levels. Logistic regression was performed to investigate predictors of non-adherence. The level of significance was set as a p-value < 0.05 using the adherent group as reference. Results Characteristic of study participants and adherence A total of 165 women interviewed to participate in the study, 124 women met the inclusion criteria and completed the questionnaires. The mean age was 50.00±9.383 years (range 30 - 78). Most of them were married (83.06%), unemployed (79.84%), medium-income (48.39%), and (79.84%) women with primary school education. The median of AHT duration was 18 months (6-36). 41.94% of women could not buy their medications from private sectors if they are unavailable in the Oncology center, since they may stop their treatment until being available in the center. 54.84% of women had chronic diseases, where hypertension (41.94%) and diabetes mellitus (25.81%) were the most frequently reported among the study sample. There is a significant association between non-adherence and unemployed (p = 0.002), retired women (p = 0.002) and the presence of side effects (p = 0.04). Sociodemographic and clinical characteristics are summarized in table 1. Table 1. Sociodemographic and clinical characteristics of participants Variables Overall Number (N)=124 Adherence level P value Adherers (N =31 ) Non-adherers (N =93 ) Age (years), mean ± SD 50.00±9.383 52.74±11.04 49.09±8.638 0.06 Residency, N (%) Urban Rural 100(80.65) 24(19.35) 25(80.65) 6(19.35) 75(80.65) 18(19.35) >0.9 Employment status, N (%) Employee Unemployed Retired 20(16.13) 99(79.84) 5(4.03) 5(16.13) 24(77.42) 2(6.45) 15(3.22) 75(80.65) 3(16.13) 0.02* 0.02* marital status, N (%) married single widow divorced 103(83.06) 6(4.84) 14(11.29) 1(0.85) 26(83.87) 1(3.23) 4(12.90) 0(0) 77(82.79) 5(5.37) 10(10.75) 1(1.07) 0.64 0.79 Income, N (%) Good >1,000,000 IQD Medium 500,000-1,000,000 IQD Poor <500,000 IQD 13(10.48) 60(48.39) 51(41.13) 1(3.23) 20(64.52) 10(32.26) 12(12.90) 40(43.01) 41(44.09) 0.06 0.31 Smoking, N (%) No Yes 121(97.58) 3(2.42) 30(96.77) 1(3.23) 91(97.85) 2(2.15) 0.66 Educational level, N (%) 0.9 Side effects, N (%) No Yes 21(16.94) 103(83.06) 9(29.03) 22(70.97) 12(12.91) 81(87.09) 0.04* Chronic disease, N (%) No Yes 58(46.77) 66(53.23) 13(41.94) 18(58.06) 45(48.39) 48(51.61) 0.53 Number of chronic illness, N (%) 1 ≥2 39(59.09) 27(40.91) 9(50) 9(50) 30(62.50) 18(37.50) 0.36 Diabetes mellitus, N (%) No Yes 92(74.19) 32(25.81) 22(70.97) 9(29.03) 70(75.26) 23(24.74) 0.64 Hypertension, N (%) No Yes 72(58.06) 52(41.94) 14(45.16) 17(54.84) 56(61.54) 35(38.46) 0.11 Ischemic heart disease, N (%) No Yes 120(96.77) 4(3.23) 30(96.77) 1(3.23) 90(96.77) 3(3.23) >0.9 Number of other medication, N (%) No 1 ≥2 63 29 32 14 8 9 49 21 23 0.58 0.53 * =p< 0.05 indicate statistically significant differences. Adherence of the study participants Overall, MMAS score in patients was 6.55 ± 1.35. Only 31 (25%) study individuals were high adherent, whereas 93 (75%) women were non- adherent. 40.32% of women forgot to take their medication. 24.19% of them did not take their medication at least once in the last 2 weeks. 5.65% of women stopped taking their medications because they felt worse when taking them. 9.68% of women forgot to take their AHT medication when they have a trip. Most of them (93.55 %) answered that they take their medication yesterday. 0.81% (one individual) of women answered yes as she stopped taking her medication when became in a good health. 35.48% of women were hassled about the treatment plan. About half of women (46.77%) did not forget to take their medication (see table 2). Iraqi J Pharm Sci, Vol.30(Suppl.) 2021 Adherence &beliefs of breast cancer patients 35 Table 2. Self-reported medication adherence behavior of study participants as determined by the MMAS- 8. MMAS-8: morisky medication adherence scale -8 items. Side effects of AHT and the impact on adherence The total number of women who had side effects was 103 participated women (83.06%) with a significant proportion in non-adherent women (87.09%) when compared with adherent women (70.97%). The most frequent side effects reported were hot flush (79.61%), joint pain (76.70%), night sweating (39.81%), vaginal discharge (22.33%), fatigue (11.65%) and depression (10.69%) (see Table 3). Table 3. Number (N) and percentage (%) reporting side effects, for total patients as well as for adheres and non-adheres patients. BMQ and impact on adherence The majority of women supported the necessity of AHT by answering agree or strongly agree that their medications have protected them from being worse and their state improved by their medications. The concerns about AHT were also reported. Many women answered agree or strongly agree that they were not familiar with their medications and they were worried from a long term effect of their medication. Approximately, all women answered that the doctors are reliable on medicines and if doctors had more time with their patients they would prescribe fewer medicines. The Item Number and percentage (%) of female patients who answered yes Do you sometimes forget to take your breast cancer oral medication? 50 (40.32) People sometimes miss taking their medications for reasons other than forgetting. Thinking over the past two weeks, were there any days when you did not take your breast cancer oral medication? 30 (24.19) Have you ever cut back or stopped taking your breast cancer oral medication without telling your doctor because you felt worse when you took it? 7 (5.65) When you travel or leave home, do you sometimes forget to bring along your breast cancer oral medication? 12 (9.68) Did you take your breast cancer oral medication yesterday? 116 (93.55) When you feel like your breast cancer is under control, do you sometimes stop taking your medication? 1 (0.81) Taking medication every day is a real inconvenience for some people. Do you ever feel hassled about sticking to your breast cancer treatment plan? 44 (35.48) How often do you have difficulty remembering to take all your medications? Never/rarely Once in a while Sometimes Usually Always 58 (46.77) 43 (34.68) 15 (12.09) 7 (5.65) 1 (0.81) Side effect Total, N (%) Adherence level Adheres, N (%) Non-adheres, N (%) Any 103/124(83.06) 22/103(21.36) 81/103(78.64) Hot flush 82/103(79.61) 17/22(77.27) 65/81(80.25) Night sweating 41/103(39.81) 8/22(36.36) 33/81(40.74) Joint pain 79/103(76.70) 17/22(77.27) 62/81(76.54) Fatigue 12/103(11.65) 1/22(4.55) 12/81(14.81) Vaginal discharge\dryness 23/103(22.33) 7/22(31.82) 16/81(19.75) Depression 11/103(10.69) 2/22(9.09) 9/81(11.11) Iraqi J Pharm Sci, Vol.30(Suppl.) 2021 Adherence &beliefs of breast cancer patients 36 mean rank of total belief scores of each section showed that adherent women had non-significant high specific‑necessity belief, low specific‑concern belief, high general‑harm belief and low general‑overuse belief. In terms of BMQ items, there were no significant differences between adherent or non-adherent women. (Table 4) Table 4.Response to BMQ items and participants’ scores for each item by adherence level BMQ: beliefs about medication scale. Item Total, Agree/strong ly, Agree answers N (%) Adherence level Wilcoxon Z scores P-value Adherers Non-adherers Mean rank Specific‑necessity BMQ necessity score, as a total 65.13 61.62 -0.476 0.634 1-My life would be impossible without medicine 76(61.29) 42.61 37.13 -0.974 0.330 2-Without medicine I'll be very ill 81(65.32) 43.57 40.10 -0.602 0.547 3-My health, at present, depending on my medicine 87(70.16) 49.29 42.32 -1.131 0.258 4-My medicine protected me from becoming worse 89(71.77) 50.45 43.32 -1.133 0.257 5-My health in the future depends on my medicine 86(69.35) 50.97 41.52 -1.468 0.142 Specific‑concern BMQ concerns score, as a total 58.16 63.95 -0.779 0.436 6-I sometimes worry about the long term effect of my medicine 73(58.87) 43.47 35.18 -1.396 0.163 7-Having to take medicine scares me 75(60.48) 43.44 36.53 -1.137 0.256 8-I sometimes worry about becoming too dependent on my medicine 43(34.67) 25.85 20.83 -1.123 0.262 9-My medicine disrupt my life 17(13.71) 8.25 9.41 -0.467 0.641 10-My medicines are mystery to me 79(63.70) 46.39 38.62 -1.156 0.248 General‑harm BMQ harms score, as a total 62.38 61.88 -0.068 0.946 11-People who take medicines should stop their treatment for a while every now and again 7(5.65) 3.50 4.08 -0.255 0.799 12-Most medicines are addictive 39(31.45) 19.40 20.21 -0.197 0.844 13-Medicines do more harm than good 49(39.52) 23.91 25.32 -0.295 0.768 14-All medicines are poison 68(54.84) 32.26 35.25 -0.547 0.585 General‑overuse BMQ overuse score, as a total 59.68 63.44 -0.512 0.609 15-Doctors use too many medicines 15(12.09) 9.83 7.54 -0.808 0.419 16-Doctors place too much trust on medicines 117(94.35) 60.04 58.67 -0.188 0.851 17-If doctors had more time with their patients they would prescribe fewer medicines 122(98.38) 58.42 62.55 -0.569 0.569 18-Natural remedies are safer than medicines 32(25.80) 16.63 16.46 -0.044 0.965 Iraqi J Pharm Sci, Vol.30(Suppl.) 2021 Adherence &beliefs of breast cancer patients 37 Multivariate analysis of factors predicting non- adherence The factors included in this test were age, education, side effects, and BMQ sections (specific- necessity, specific-concerns, general-harm, and general-overuse). No one of these variables was a significant predictor of non-adherence (Table 5). Table 5. Factors predicting non-adherence OR: Odd Ratio, CI: Confidence Interval (lower-upper), BMQ: beliefs about medication scale. Discussion: In the current study, the adherence was suboptimal and the majority of women (75%) were non-adherent to AHT. The results of this study were in agreement with those of previous studies that examined adherence to AHT (17,22,23). The level of adherence to AHT is greatly below the level investigated in the study conducted by Karbala/Iraq who found that (62.38%) of postmenopausal women are highly adherent to AIs (16). Another study in Sudan found revealed that high percent of patients (93%) were adherent to AHT (24). This confliction may be attributed to the type of method used to measure adherence such as face to face interviews, self-reported questionnaires, pill count, electronic monitoring devices, and medical records. There is no standard method to measure medication adherence precisely (25). Non-adherence is a multifactorial problem that affects therapy outcomes and lead to disease recurrence, re-hospitalization, and decrease survival rate (26). Several studies found that socioeconomic status and clinical data including older age, single, low income and out-of-pocket cost of AHT (26–31), comorbidity, treatment side effects, depression (32–34) are associated with non-adherence. In this study, non-adherence is significantly associated with side effects of AHT and the employment state of women. This finding was supported by several studies investigated the factors associated with non-adherence indicating that side effects are a potential contributing factor (35). Unemployed and retired women were significantly non-adherent. In contrast, a previous study in the UK found that in-paid employment was more likely to be non-adherent to AHT (32). These differences imply that these results needed further investigation. Patients' beliefs about their medications were observed to correlate with medication adherence. A positive association between high score specific-necessity and adherence while a high score of specific-concern showed significantly in patients with poor adherence. Many studies of chronic diseases and cancer revealed these associations (10,12,17,36) but in our study, binary logistic regression test found no positive or negative significant association between each part of BMQ and adherence. This is similar to previous studies that investigated no effects of beliefs on adherence (37–39). This may be due to our small sample size and may have insufficient strength to find a significant effect. The limitations of this study, are limited to one center and does not represent all Iraq population, many variables are related to the adherence were not included in this study such as self-efficacy, perceived social support, patient-physician communication, and severity of symptoms, the data presented here reflects only the AHT adherence using a questionnaire through face to face interview. In our opinion, this method is more accurate than obtaining data from self-reported questionnaires, prescription and pharmacy records and medical claims methods. Still, all those observational methods remain limited (40). A confirmation method that measures the medications or related markers in blood is more accurate (41) and recommended in future studies. Conclusion This study provides important information about the adherence extent of Iraqi women with breast cancer to their AHT and factors leading to poor adherence. A majority of women were non- adherent to their treatment. Side effects and unemployment women were the only factors investigated to be associated with non-adherence. There was no positive or negative association between beliefs and adherence. Variable OR (95% CI) P value Age 1.037 (0.989-1.088) 0.135 Education 1.523 (0.381-6.084) 0.551 Employment 1.011 (0.209- 4.895) 0.989 Side effect 0.423 (0.143-1.252) 0.120 BMQ-specific-necessity 1.009 (0.926-1.101) 0.833 BMQ-Specific-concerns 0.935 (0.853-1.023) 0.144 BMQ general-harm 1.051 (0.904-1.221) 0.518 BMQ-general- overuse 0.930 (0.738-1.172) 0.541 Iraqi J Pharm Sci, Vol.30(Suppl.) 2021 Adherence &beliefs of breast cancer patients 38 Competing interests The authors confirm that there is no conflict of interest. Funding The authors did not receive any external funding for this work. Availability of data and materials: The databases used and/or analyzed for the present study are accessible from the corresponding author on reasonable request. References 1. Cancer Today. 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