Authors
- Arthurs, Gilly MSN, RN, FNP-BC
Abstract
Review question: In adult cancer patients, 18 years and older, what is the effectiveness of therapeutic patient education on adherence to oral anti-cancer medicines (OAMs) in an ambulatory care setting?
Background: The International Agency for Research on Cancer (IARC), estimates that there will be 14.1 million new cancer cases each year worldwide.1 The United States (US) anticipates that 1.7 million new cancer cases will occur in 2014.2 The management of patients with cancer has expanded from traditional surgical intervention, radiation therapy and conventional intravenous chemotherapy agents to include innovative oral anti-cancer medicine (OAM).3 Oral anti-cancer medicine are drugs that have direct anti-tumor activity including cytotoxic agents or targeted therapies.3, 4 The development of OAMs in 1953 has made it possible for cancer patients to receive oral agents instead of invasive intravenous chemotherapy.5, 6 The number of adult patients with cancer receiving OAM treatments have grown in the last decade.3, 4, 7 "Approximately 25-30% of the oncology drug pipeline involves oral agents and there are now over 50 OAMs approved by the Food and Drug Administration."8(p.231) Cost-effectiveness, patient preference, patient convenience, responsibility of self-management of medication administration, and the less invasive medication option are factors in favor of OAM treatment.3, 5-7, 9, 10
In the ambulatory care setting, which includes outpatient clinics, community health centers, group practices and primary care practices,11 the oncology practitioner can prescribe an OAM after a comprehensive assessment and patient examination.11,12 Patient understanding of OAM treatment will be essential to promote patient safety and adherence to the prescribed regimen.3 Opportunities for educating patients about dosage, medication scheduling, adherence and side effects can support optimal use of OAM therapy.12 A "one-size fits all" approach to educating patients on OAMs can be harmfulandeducation should be tailored for each individual patient to ensure appropriate and patient-specific information is provided regarding OAM treatment and adherence.3,5-7,12
The World Health Organization (WHO) defines adherence as the extent to which a person's behavior corresponds with a healthcare professional's agreed recommendations.13 The patient's values, lifestyle and beliefs should be aligned with the healthcare provider's advice and opinion to promote medication adherence. Patients with cancer who are receiving OAMs require them on a continual basis without any interruption to maximize their effectiveness in targeting the cancer cells.14 Currently, there is no gold standard method to measure adherence.15,16 Estimates of adherence to long-term OAM regimens range from 17% to 80%.17 Patient adherence to an OAM is key to resolving symptoms, enhancing treatment efficacy, improving quality of life and overall survival.14
The impact of patient non-adherence to OAMs can result in increased utilization of health care services, rising health care costs and poor health outcomes.8, 17 Poor adherence to OAMs can involve the patient's understanding of their diagnosis and how OAMs can improve their prognosis.18 A multitude of factors including psychosocial and socioeconomic factors, medication cost, complicated dosing schedules, drug-drug interactions, food-drug interactions, adverse effects, inconsistent patient follow up, inadequate educational information and medication accessibility can influence patient adherence to OAMs.8, 19 Non-adherence to OAMs may decrease the effectiveness of the patient's cancer treatment.20 Understanding factors that contribute to poor adherence of OAMs are essential to improve health behaviors.21
Health care professionals will need effective and sustainable measures to monitor patient adherence to OAMs, however establishing practical methods for measuring OAM adherence is not an easy task when the patient is self-administering medications at home.8,13,19,22 Patient's self-reporting of issues surrounding medication adherence can be ascertained through interview and diaries to provide insight into patient-perceived barriers.23,24 A short tool such as the Medication Adherence Questionnaire (MAQ)is a simple scale to administer and score; it is validated in many patient populations, and is a good tool to assess adherence in patients with cancer in an ambulatory care setting.22 Other valid and reliable instruments that assess medication adherence are the Morisky Medication Assessment Scale, the Medication Adherence Self-Efficacy Scale (MASES), the Medication Adherence Report Scale (MARS), and the Beliefs about Medicine Questionnaire (BMQ), Brief Illness Perception Questionnaire(IPQ).23,24 Pill counts, pharmacy refill records and medication event monitoring systems (MEMs) are objective methods to measure patients' adherence to OAMs.24
Fewer than 50% of patients who receive routine education correctly follow treatment instructions because instructions tell patients what to do without knowing what is relevant to their learning needs.25 Routine patient education is a process for healthcare professionals to communicate information to the patient verbally or in writing, that may alter one's health behaviors or improve health status.25 Patients with cancer receiving routine education in the ambulatory care setting may not have continual monitoring by the health care professional. Lack of consistency in monitoring patients may not ensure a change in knowledge, health behavior or possible improvement to medication adherence.25 Routine education may not provide enough specific, comprehensive patient oriented information, focused on motivation and a change in behavior to make a difference in patients at risk for poor adherence to OAMs.25,26
According to the WHO, the evolution of innovative changes for educating patients with a chronic disease such as cancer is to transition from routine patient education to a therapeutic patient education approach.27 Therapeutic patient education is defined as a coordinated set of educational activities proposed by the healthcare team that involve other professionals, the patient and family members.27 Therapeutic educational interventions are multidimensional strategies that can guide clinical decisions; align patient beliefs to promote self-management skills and medication adherence therefore reducing treatment complications.28-31
The implementation of therapeutic education strategies can be achieved with the use of teaching tools. The Multinational Association of Supportive Care in Cancer (MASCC) is a simple, therapeutic and comprehensive standardized tool developed for health care providers to educate cancer patients receiving OAMs.32, 33 The tool is well known worldwide and is available in several languages.32, 33 Additional therapeutic patient educational approaches are the B-SMART model and ACE-ME model.34-36 These models contain teaching tools and activities related to assessment, collaboration, education, monitoring and evaluation of patient's medication adherence.34-36 The patient with cancer can collaborate and partner with trained healthcare professionals to acquire knowledge, skills, and ownership for their disease, that may improve OAM adherence and their quality of life.30-37
In the ambulatory care setting, patients receiving OAMs may be supported by behavioral strategies that can sustain motivation, promote self-management and encourage adherence in their everyday life38. Therapeutic patient education using evidence-based educational resources, weekly follow-up, telephone communication, drug package reminders and calendars is one strategy that may be used to guide patients.27,31-39 Initiation and reinforcing of information can promote understanding of the drug's purpose, side effects and the need for continued adherence, taking into account that transitions and changes can occur in patients' lives.27,32-38 The challenge for adherence is to ensure that patients are well informed, supported and capable of managing their OAMs as prescribed. The utilization of simple and cost effective therapeutic patient educational tools may improve OAM adherence in adult patients with cancer in an ambulatory care setting when the education provided encourages knowledge enhancement and motivates patients to assume a certain level of responsibility for their own health care.
No systematic reviews were found on the effectiveness of utilizing therapeutic patient education to improve adherence of OAMs in adult cancer patients during the preliminary search of CINAHL, PubMed, The Cochrane Library, Google Scholar and The JBI Database of Systematic Reviews and Implementation Reports. A systematic review on OAM treatment adherence in adult cancer patients and the use of therapeutic education would efficiently integrate existing evidence and provide data for rational decision making in patients with cancer in an ambulatory care setting.
Article Content
Inclusion criteria
Types of participants
This review will consider studies that include all adult patients aged 18 and older, of any gender and ethnicity and diagnosed with any form of cancer, receiving OAMs in an ambulatory care setting. Adult patients with cancer receiving intravenous or non-oral chemotherapy will be excluded from this review.
Types of intervention(s)
This review will consider studies that evaluate the use of therapeutic patient education as the additional intervention to routine patient education to promote OAM adherence in adult cancer patients in an ambulatory care setting. Therapeutic patient education is a coordinated set of educational activities proposed by a healthcare team that involve other professionals and family members. Therapeutic patient education can empower patients and family members to manage life with a chronic disease, based on a set of integrated and organized actions, including psychosocial support, designed to make patients and family members more autonomous by acquiring knowledge and skills to make them agents of their own change, thus improving their wellbeing and quality of life.27
Comparator
Interventions will be compared with routine patient education. Routine patient education is defined as a process health care professionals regularly follow and utilize to communicate information to the patient that may alter one's health behaviors or improve health status.25
Types of outcomes
The primary outcome of this review is adherence to prescribed OAMs. The definition of adherence encompasses the extent to which a person's behavior when taking medication, following a diet, and/or accomplishing lifestyle changes follows or agrees with recommendations made by healthcare professionals.13
Adherence will be measured using validated and reliable tools that assess medication adherence including, the Medication Adherence Questionnaire (MAQ),22 the Morisky Medication Assessment Scale, the Medication Adherence Self-Efficacy Scale (MASES), the Medication Adherence Report Scale (MARS), the Beliefs about Medicine Questionnaire (BMQ),and the Brief Illness Perception Questionnaire(IPQ).23,24 Studies with objective methods for measuring medication adherence will also be considered in this review including, but not limited to, pill counts, pharmacy refill records and medication event monitoring systems (MEMs).23,24
Types of studies
This review will consider randomized controlled trials (RCTs) that evaluate the effectiveness of therapeutic patient education to improve adherence of OAM in adult cancer patients in an ambulatory care setting. In the absence of RCTs other research designs such as experimental studies without randomization and quasi-experimental studies will be considered for inclusion.
Search strategy
The search strategy aims to find both published and unpublished studies in English. A three-step search strategy will be utilized in this review. An initial limited search of PubMed and CINAHL will be undertaken followed by analysis of the text words contained in the title and abstract, and of the index terms used to describe article. A second search using all identified keywords and index terms will then be undertaken across all included databases. Thirdly, the reference list of all identified reports and articles will be searched for additional studies. Only studies published in English and studies in or after 1953 when OAMs were developed will be considered for this review. Databases will be searched for studies from the inception of OAMs in 1953 through the current date of the review.
The databases to be searched include:
Cumulative Index to Nursing and Allied Health Literature (CINAHL), PubMed, Excerpta Medica Database (EMBASE), Academic Search Premier, Cochrane Library, PsycINFO, and Health Source: Nursing/Academic Edition.
The search for unpublished studies will include:
Dissertation Abstracts Online, Google Scholar, government health department websites: World Health Organization (WHO)http://www.who.int, National Institute of Health (NIH) http://www.nih.gov, Institute of Medicine (IOM)http://www.iom.edu, Agency for Healthcare Research and Quality's (AHRQ)http://www.ahrq.gov, the Virginia Henderson Library of Sigma Theta Tau International, ProQuest Dissertations & Theses, Clinical Trials.gov, New York Academy of Medicine and relevant oncology websites: American Society of Clinical Oncology (ASCO) http://www.asco.org, Oncology Nursing Society (ONS) http://www.ons.org, European Society for Medical Oncology (ESMO) http://www.esmo.org, American Cancer Society (ACS)http://www.acs.org, National Cancer Institute (NCI) http://www.cancer.gov. Hand searching of reference lists and bibliographies of included studies and appropriate journals including American Journal of Clinical Oncology, Annals of Oncology, Journal of Clinical Oncology, Clinical Journal of Oncology Nursing, Cancer Nursing, The Journal of National Comprehensive Cancer Network, Seminars Oncology Nursing, and The Oncologist for the preceding six months will be conducted to ensure all relevant studies have been considered.
Initial keywords to be used will be:
Adult, cancer, oral chemotherapy, therapeutic education, patient education, neoplasm, medication adherence, patient compliance, medication compliance.
Assessment of methodological quality
Papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Meta Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) (Appendix I). Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer.
Data collection
Data will be extracted from papers included in the review by two independent reviewers using the standardized data extraction tool from JBI-MAStARI (Appendix II). The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives. Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer.
Data synthesis
Quantitative data will, where possible, be pooled in statistical meta-analysis using JBI-MAStARI. All results will be subject to double data entry. Effect sizes expressed as odds ratio (for categorical data) and weighted mean differences (for continuous data) and their 95% confidence intervals will be calculated for analysis. Heterogeneity will be assessed statistically using the standard Chi-square and also explored using subgroup analyses based on the different study designs included in this review. Where statistical pooling is not possible the findings will be presented in narrative form including tables and figures to aid in data presentation where appropriate.
Conflicts of interest
There are no conflicts of interest.
Acknowledgements
This review will partially fulfill degree requirements for successful completion of the Doctor of Nursing Practice Program at Pace University, College of Health Professions, New York, NY for Gilly Arthurs, MSN, RN, FNP-BC, Janice Simpson, MS, RN, ANP-BC, NP-C, FNP, Andrea Brown, MSN, RN, FNP-BC, Ohnma Kyaw, MSN, RN, ANP-BC, FNP, WCC, Sharon Shyrier, MSN, RN, FNP-BC
The authors would like to personally thank Jason Slyer, DNP, RN, FNP-BC for his guidance and assistance with the systematic review protocol.
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Appendix I: Appraisal instruments
MAStARI appraisal instrument[Context Link]
Appendix II: Data extraction instruments
MAStARI data extraction instrument[Context Link]
Keywords: Adult; cancer; therapeutic patient education; oral anticancer medicines; medication adherence