SH7008 Research Methods for Health and Social care170005541IntroductionBreast cancer (BC) is “a disease in which cells in the breast grow out of control” (Centers for Disease Control and Prevention, n.d, p. 1).
In the United States (US), breast cancerin women is a highly prevalentcancer (except for skin cancer)with more than 245, 000 women diagnosed each year (Centers for Disease Control and Prevention, 2019). Although both men and women can get BC, the lifetime risk of being diagnosed with BC among US men is rare with 1 in 1000 compared to 1 in 8 women (National Breast Cancer Foundation, 2019). BC is most commonly diagnosed among women over the age of 50 however, it can also affect younger women with 10% of new BC cases in the US being diagnosed in women younger than 45 years old (Centers for Disease Control and Prevention, n.d). Breast canceraccounts for an average of 15.2% of all new cancer cases and 40,000 death each year (National Breast Cancer Foundation,2019; Centers for Disease Control and Prevention, 2019).According to the Centresfor Disease Control and Prevention (2019) in the United States each year between 1999-2016 the number of new BC cases hadbeen rising due to the ageing population and population growth. Between 2012-2016, there was a 0.3% increase in the incidence rate of female BC (DeSantis et al., 2019).
In contrast, from 1989 to 2017, 375,900 BC death hasbeen avoided, which is a 40% decline in BC mortality rate (DeSantis et al., 2019). Nonetheless, it is the second leading cause of cancer mortality among US women (DeSantis et al., 2019). One of the main reasons for the decline in female BC mortality rate might be due tothe improvement in anti-hormone treatment such as endocrine therapy (Centers for Disease Control and Prevention, 2019; DeSantis et al., 2019; Awan and Esfahani, 2018).
This research proposal will commence with a background of the most common form of BC, estrogen positive breast cancer and the importance ofendocrine therapyin increasing disease-free survival rate in BC patientsincluding the rationale for the study.Then theaim of the proposed study and four objectiveswill be provided. This will be followed by the methodology section which will include the study design, literature search strategy, studyappraisal tool and data analysis method as well as
SH7008 Research Methods for Health and Social care170005542ethical issues that will be considered. Finally,a time table outlining the time for the proposed projectwill be provided. BackgroundTwo out of three (75%) of breast cancers are estrogen positivehormone receptive (ER+)(Shah et al., 2020).
Thus, women whose BC is ER+ are prescribed one of the two main types of endocrine therapy-tamoxifen,an oestrogen receptor modulatorwhich is prescribed primarily to premenopausal women and aromatase inhibitors (AIs) such as Exemestane, Letrozole and Anastrozole for postmenopausal women which significantly reduces plasma oestrogen levels (Benderet al.,2014). Adjuvant endocrine therapy (ET) also known as hormone treatment (HT) is prescribed for up to ten yearsto reduce the risk of breast cancer recurrence and improve patients’chance of survival (Shah et al., 2020).ET has been proven to reduce the risk of recurrence in breast cancersurvivors by up to 50% (Lambertet al.,2018). Also, BCmortality reduces by 33% in the ten years after initial treatment iftamoxifen is taken for five years while the risk ofmortality reduces by approximately 50% if tamoxifen is maintained for additional ten years (Early Breast Cancer Trialists’ Collaborative Group, 2011; Zhijun, Wei and Bradley, 2018).
Besides, ET effectively reduces the risk of metastatic BC growth and progression in women whose tumours arehormone-sensitive (Salkeni and Hall, 2017).Hence, adherence to adjuvant hormone therapy has become increasingly vital for improved recurrence and disease-free survival outcome (Lambertet al.,2018). Moreover, the implication of nonadherence to ET could result in an increased number of visits to a physician, compromised treatment efficacy, higher hospitalisation rates and reduced disease-free and overall survival rate (Moon et al.,2017; Bender et al., 2014). Notwithstanding the proven clinical efficacy of ET, adherence among women in the US is suboptimalwith 31-73% of women with ER+ BCfailingto stay on recommended regimen or stop treatment (Shah et al., 2020; Lambertet al.,2018). Evidence also suggests that nonadherence to ET varies between tamoxifen (59%)
SH7008 Research Methods for Health and Social care170005543and AIs(50%) (Murphy et al., 2012). According to the National Institute for Health and Care Excellence (NICE) (2009, p.2),the notion ofadherence is defined as “ the extent to which a patient’s action matches the agreed recommendations”whilenon-adherence to long term therapy can be classified as unintentional or intentional.
Unintentional nonadherence to long term therapy occurs due to barriers such as not remembering, not understanding therapy instruction or their inability to pay for therapy despite the will to follow the recommended therapy (NICE, 2009). Conversely, intentional nonadherence occurs due to the individual’s perception and beliefs about the treatment and decides to stop treatment (NICE, 2009).The Necessity-Concerns Framework (NCF) can be utilised to understand a patient’sdecision to adhere / notadhere to long term ET(Horne et al.,2013). Thus, adherence to therapy depends onthe individual’s belief about the necessity of the treatment and their beliefabout the adverse outcome associated with takingthe treatment(Horne et al.,2013).
Furthermore, both quantitative and qualitative studies have foundthat factors such assevere side effects, lower quality of lifeand poor patient-provider communicationare associated withnonadherence to ET (Bluethmann et al., 2017; Chlebowski, Kim and Haque, 2014; Chalela et al., 2018; Pan et al., 2018).What is more, adherence is greater in clinical trials compared to clinical practicedue to the increased clinical contactswhich indicates that regular follow-up and support with management of side effectsincreases adherence to endocrine therapy (Chlebowski, Kim and Haque, 2014). Thus, highlights the importance of access to regular follow-up care and effective patient-physician communication. Sociodemographic and socioeconomic factors havealso been reported to independentlypredict nonadherence to ET among women in the US (Bender et al., 2014).
Evidence suggests that there is a strong association between sociodemographic factors suchasage and ethnicity andnon-adherence to ET among women in the US(Spencer, 2020). What is more, minority population who are also on a lowincome are lesslikely to integrate into the health care system thus, have poor access to health care providers resulting in suboptimal ET use (Roberts, Wheeler and Reeder-Hayes, 2015).Additionally, a retrospective cohort study of women under the age of 65 and Medicareinsured, conducted by Farias and Du
SH7008 Research Methods for Health and Social care170005544(2017) found that the cost of therapy was significantly associated with nonadherence to ET.
Similarly, in a recent quantitative study conducted by Spencer et al. (2020) lack of resources and being publicinsured were identified as barriers to adherence to endocrine therapy.Thus, privately insured women were less likely to report trade-off and resource barriers compared to Medicare insured women (Spencer et al.,2020). Economic and insurance issues have been identified as barriers to access to health care among cancer survivors in the National Action Plan for Cancer Survivorship(NAPCS) (2004)Advancing Public Health Strategies. The Action Plan recommends that survivorship advocates should educate decision-makers about the financialbarriers that cancer patients face to access quality follow-up care (NAPCS, 2004).
A descriptive assessment of the implementation of NAPCS’s and its applicability at five national organisations conducted bySmith et al. (2013)found that insurance issues such as ineligibility to public health programmes and advocacy regarding insurance issues were being addressed by educating policymakers through a variety of methods such as briefing materials and white papers. Furthermore, the National Comprehensive Cancer Network (2019) first published in 2013, recommends that cancer specialist and primary care providers should work together to support women who are on long term endocrine therapy.
The guideline recommends that patients should be provided with a personalised survivorship treatment plan which includes a personalised summary of long term toxicity of the treatment as well as follow-up recommendations (NCCN, 2019). The guideline also states that patient engagement in their treatment is vital in improving adherence to endocrine therapythus,requires frequent follow-up encouragement (NCCN, 2019). Rationale In the context provided above, considering the association between adherence and improved recurrenceand disease-free survival outcome, adherence to adjuvant hormone therapy is becoming increasingly vital.
Hence, it is crucial to identifythe key sociodemographic and socioeconomic factors that influenceadherence to adjuvant endocrine therapy among breast cancer patients as well as the extent to which those
SH7008 Research Methods for Health and Social care170005545factors influence adherence. Hence, assist in the development and implementation of effective adherence-enhancing interventions.
It is also vital to identify the key sociodemographic and socioeconomic factors influencing adherenceto optimize allocation of resources andto inform evidence-based policiesand strategies to increase endocrine therapy adherenceamong women with ER+ breast cancer.
Aim: To explore the key sociodemographic and socioeconomic factors influencing adherence to adjuvant endocrine therapy among women with estrogen positive (ER+) breast cancer in the United states.Objectives:
1.To examine the prevalence of adherence to adjuvant endocrine therapy among women with ER+breast cancer the United states
.2.To explore the key socio demographic factors influencing adherence to adjuvant endocrine therapy among women with ER+ breast cancer the United states.
3.To explore the key socioeconomic factors influencing adherence to adjuvant endocrine therapyamong women with ER+ breast cancer the United states.
4.To assess the effectiveness of nationalguidelines and strategies in promoting adherence to adjuvant endocrine therapy among women with ER+ breast cancer in the United states.
Methodology
This section will provide an overview of the methodologies that will be used to carry outthe proposed health project. It will commence with an overview of the study designand literature search strategy. Followed by an overview of the study appraisal tool that will be used to critically evaluate each study and data analysis frameworkincluding the steps that will be followed. Finally, ethical considerations will be discussed.
SH7008 Research Methods for Health and Social care170005546Study design The proposed study will be carried out using secondary research methodin the form of a narrative review of the literature. A secondary research methodis a research techniquethat involves the process of collecting and analysing data from already existing studies such as peer-reviewed original studies (Bryman, 2016; Hox and Boeije, 2005). On the contrary, a primary research method is a research method that involves theprocessof collecting original data (Bryman, 2016). Although conducting primary research would answer the specific question at hand,it is nonetheless a much more time-consuming process (Hox and Boeije, 2005).
Although in secondary analysis location and accessibility of data might be an issue, it is less time consuming compared to primary research method as the data has already been collected by other researchers (Miller and Brewer, 2011; Stewart and Kamins, 1993). What is more, one can also answer the question athand by combining different findings and conclusions from various studies using secondary research method (Stewart and Kamins, 1993).Anotheradvantage of using a secondary research method is that secondary collection and analysisof datais a less-costly process(Bryman, 2016).Also, adherence to endocrine therapy is a well-researchedtopic in the US hence, it is more practical to utilize existing data than collect new data which might also result in BC patients being over-researched.
Moreover, anarrative review of the literature might not cover all the literature and present difficulties in replicating as it is not comprehensive(Smith and Noble, 2016). Nevertheless,it is a useful method to identify gaps or omission all within summation to inform policy and/ or future researchthrough a critical interpretation and a reasonably comprehensive assessment of existing data(Grant and Booth, 2009; Smith and Noble, 2016).Literature search strategyA literature search strategy will be followed to retrieve relevant articles.
A literature search strategy is an organised structure of keywords, phrases and concepts used to search and retrieve relevant and accurate results from databases (Bryman, 2016). The use of literature search strategy is vital as it will eliminate errors in terms of retrieving irrelevant studiesandbiased informationwhich might result in an
SH7008 Research Methods for Health and Social care170005547incomplete and biased evidence base(Bryman, 2016). Additionally, it increases the replicability of the study as it gives a clear guide on how literature wasretrieved (Bryman, 2016). PICO (Population, Intervention, Comparison and Outcome
