Background: With the shift to more self-administered oral cancer treatments, there is an increased need for thorough patient education and close follow-up to reduce the risk of adherence issues and maximize safety. The purpose of this project was to enhance oncology nurse navigator (ONN) involvement in the management of oncology patients receiving oral oncolytic therapy. Subsequently, the overarching goal was to increase the quality of patient care through advancing patient understanding of their medication, limit side effects, and improve adherence.
Objectives: The primary outcome objective was for ONNs across all disease teams to utilize a standard approach to education, documentation, and follow-up of all patients receiving oral oncolytics. A long-term objective was to ensure full compliance with accreditation standards pertaining to education, documentation, and follow-up of patients receiving oral oncolytics. The process objectives were to complete ONN education on oral oncolytic therapy, develop a new tracking tool, and standardize the approach to patient education, documentation, and tracking.
Population and Setting: The cancer center comprises 3 ambulatory locations with more than 70,000 patient visits annually. It is fully accredited by the Commission on Cancer and is recognized by ASCO as Quality Oncology Practice Initiative certified.
Methods: The implementation of the project was conducted with the use of the Plan-Do-Study-Act cycle. An oral oncolytic tracking tool was built within Epic, and note templates were updated to include necessary information. During implementation, the ONN team utilized the tracking tool to identify which patients needed initial oral oncolytic education and follow-up.
Results: A metric dashboard was built to analyze data and measure outcomes. During the 4-month implementation period, 46.2% of patients (n=264) received education prior to starting on an oral oncolytic agent; 31.8% of patients (n=264) received follow-up from an ONN within the first month of starting an oral oncolytic.
Conclusions: This quality improvement project demonstrated improvement from baseline in ONN involvement in providing initial education and follow-up to patients receiving oral oncolytics. The literature clearly indicates that ONNs play a critical role in the management of oral oncolytics, and priority must be taken to ensure their workload demands allow them to provide this important care to patients.
As of 2020, the worldwide incidence of a new cancer diagnosis has exceeded 19.2 million.1 In 2024, it is estimated that more than 2 million Americans will be diagnosed with cancer and greater than 611,000 cancer-related deaths will occur.2 The good news is that survival rates now exceed 68%, up from less than 50% 35 years ago.2 Increased survival is due, in large part, to the advances in treatment, including a number of oral agents.2 The advent of oral oncolytic agents has eliminated the need for some patients to receive treatment in the oncology clinic (ie, infusion chemotherapy) and, therefore, has shifted greater responsibility to the patient within their home setting.
The advent of oral oncolytic agents has eliminated the need for some patients to receive treatment in the oncology clinic and, therefore, has shifted greater responsibility to the patient within their home setting.
First approved for use in the mid-20th century, there are now well over 100 different oral oncolytic agents used in the treatment of cancer that fall into several different categories, including targeted therapies, immunotherapy, hormonal agents, and traditional cytotoxic agents.3-5 Oral oncolytic agent development and approval have increased exponentially in recent years.6-8 Advantages of oral cancer treatment include a greater sense of control for patients, perception of improved quality of life due to less time spent in the clinic, and overall convenience.8-11
Challenges with the use of oral oncolytics include less patient oversight by healthcare providers, potential for increased side effects, safety concerns, and adherence issues due to self-administration of medications.8-10,12,13 For those reasons, practice guidelines and standards related to management of oral oncolytic therapies have been developed by several national oncology organizations, including the Oncology Nursing Society, Hematology/Oncology Pharmacy Association, and ASCO. Commonalities among the standards include performance of an initial adherence assessment, use of multimodal patient education methods, consistent follow-up, ongoing assessment and management of adverse effects, and ongoing validation of adherence.6,7,14
Due to the shift to more self-managed treatments, it has become increasingly important for patients to have a direct line of communication with a healthcare professional, such as an oncology nurse navigator (ONN). ONNs help patients navigate the care continuum from diagnosis, through treatment, into survivorship and/or end-of-life care.15,16 Key components of the ONN role include coordination of care, identification of patient needs, facilitation of interdisciplinary collaboration, provision of patient education, and patient advocacy.15-17 Furthermore, Standard 12 of the Oncology Navigation Standards of Professional Practice calls for ONNs to provide support and information to patients receiving cancer treatment through conducting education, promoting timely follow-up, monitoring adverse effects, and promoting patient adherence to the treatment plan.18 Patients have expressed feeling supported, more engaged, less anxious, and better informed when an ONN is involved in their care, creating a trusting relationship.12,17
Patient education and intentional, consistent follow-up beyond clinic visits are critical to the sustainability of treatment and quality patient care.10,19,20 Education regarding oral oncolytic therapy should be individualized to each patient and include information about the medication schedule, the importance of taking medication as prescribed, and potential side effects.11,21-23 This individualized patient education results in greater patient satisfaction, less severe medication-related adverse effects, and improved adherence.11,21-23 Consistent follow-up is important in the early identification of side effects and reinforcement of treatment plans.13,24-26 Specifically, nurse-led follow-up allows for more real-time management of side effects, increased patient satisfaction, and increased medication adherence.13,24-26
There has been an exponential increase in oral oncolytic utilization over the past decade, with oral agents comprising an estimated 30% to 50% of new anticancer drug approvals.27,28 With the shift to more self-administered oral cancer treatments, there is an increased need for thorough patient education and close follow-up to reduce the risk of adherence issues and maximize safety.12 ONNs are uniquely positioned to provide this care to patients. At a large Midwest cancer center attached to an academic medical center, a Quality Oncology Practice Initiative (QOPI)-certified practice, there is not a standardized approach among ONNs with education, tracking, and follow-up of patients receiving oral oncolytic therapy. ASCO QOPI standards require oncology practices to have and adhere to a policy that outlines written pretreatment education provided to patients, assessment of patients’ aptitude to adhere to treatment, and designated follow-up intervals to assess side effects and adherence.29
There has been an exponential increase in oral oncolytic utilization over the past decade, with oral agents comprising an estimated 30% to 50% of new anticancer drug approvals.
The purpose of the project was to enhance ONN involvement in the management of oncology patients receiving oral oncolytic therapy and subsequently advance patient understanding of their medication, limit side effects, and improve adherence. Specifically, ONNs can provide in-depth education to patients regarding treatment, including administration schedule, possible side effects, when to communicate with the healthcare team, and how to safely handle medication.
Prior to project implementation, ONNs across numerous disease teams within the cancer center varied in their approach to managing patients receiving oral oncolytics, especially pertaining to patient education, tracking, follow-up, and encounter documentation. A defined and standardized methodology was necessary to help increase the quality of patient care.
Attached to a large academic medical center, the cancer center comprises 3 locations, situated on Chicago’s West Side, with more than 70,000 patient visits annually. The cancer center is fully accredited by the Commission on Cancer and is recognized by ASCO as QOPI certified.
The cancer center employs more than 150 registered nurses in various roles, including ONNs, nurse coordinators, triage nurses, research nurses, and infusion nurses. Working within a defined disease team, ONNs play an important role in coordinating comprehensive care for patients throughout their cancer journey and across the care continuum. ONNs manage major aspects of cancer care from initial diagnosis, throughout treatment, and into survivorship or end of life, including patient education, symptom management, insurance and financial challenges, promotion of collaborative interdisciplinary care, and facilitation of support services.
The primary outcome objective was for ONNs across all disease teams to utilize a standard approach to education, documentation, and follow-up of all patients receiving oral oncolytics. As a result, patients initiating a new oral oncolytic will receive education by the ONN on the medication. Additionally, patients receiving an oral oncolytic agent will have follow-up performed by an ONN within the first month of beginning therapy. A long-term objective was to ensure full compliance with accreditation standards pertaining to education, documentation, and follow-up of patients receiving oral oncolytics.
The process objectives were to complete ONN education on oral oncolytic therapy, develop a new tracking tool, and standardize the approach to patient education, documentation, and tracking.
The implementation and evaluation of the project was conducted with the use of the Plan-Do-Study-Act (PDSA) cycle. PDSA is a tool commonly used in quality improvement to test change. The first step in the cycle is to develop a “Plan,” including the who, what, where, when, and necessary data to be collected. Next is “Do,” in which the plan is implemented. Then in the “Study” phase, the data, observations, and results are collected and analyzed. Lastly, the “Act” phase demands a determination of the next steps, including adaptation, adoption, or abandonment of the plan.30,31
Over the course of a few months and many meetings, several ONNs and the project lead collaborated with the EMR information technology analyst team to develop a tracking tool within the EMR.
In addition to the attainment of stakeholder support, several activities comprised the planning phase of the project. To verify required accreditation standards related to oral oncolytic therapy, the project lead met with the cancer quality team. Next, the current state of ONN involvement in oral oncolytic therapy was identified through discussions with and survey of ONNs that revealed inconsistent approaches across disease teams. For example, some ONNs were consistently providing education to patients but were not intentionally following up with patients. Some ONNs admitted to having no involvement in providing education or follow-up to patients receiving oral oncolytics. Additionally, baseline compliance data, including completion of patient education, follow-up, and documentation for patients receiving oral oncolytics, were obtained through chart audits of new oral oncolytic initiations for a 3-month period (see Results). This information reinforced the need for a standardized approach to providing oral oncolytic–related patient education and follow-up. In addition, the oral oncolytic pharmacists were queried to determine their involvement in the management of patients receiving oral oncolytics. Since the in-house pharmacy is a specialty pharmacy, the pharmacists are required to provide education to patients receiving oral oncolytics. However, it was discovered that the pharmacists document in a separate program outside of the electronic medical record (EMR) that is not visible to other members of the care team. Over the course of a few months and many meetings, several ONNs and the project lead collaborated with the EMR information technology (IT) analyst team to develop a tracking tool within the EMR. After numerous testing events and multiple iterations, the tracking tool was revised to ensure all necessary information was captured. Additionally, the existing oral oncolytic note templates were updated based on guidelines and requirements identified in the QOPI standards.
During the “Do” phase of the project, several hybrid (virtual and in-person) 1-hour training sessions were held for the ONN team. These sessions reviewed the functionality details of the new EMR tracking tool and policy expectations related to providing evidence-based education and follow-up to patients receiving oral oncolytic therapy. In addition, the training outlined the use of Oral Chemotherapy Education Sheets31 collaboratively published by several oncology organizations, use of the templated oral chemo initial or follow-up documentation note, and expectations on the use of the EMR tracking tool. After ONN training occurred, the IT team moved the tracking tool into the live EMR environment, and the ONN team began utilizing the standardized process for management of patients receiving oral oncolytics.
The “Study” phase included data collection and analysis of ONN involvement in providing oral oncolytic–related education and follow-up. Collaboration with a data analyst led to the development of a metric dashboard to capture raw numbers of completion of initial patient education and follow-up. Specifically, the data were comprised of the number of times the initial patient education note template and follow-up note template were utilized because use of these notes indicates that the ONN has, in fact, provided the proper education and/or follow-up to patients. Accordingly, the dashboard included the number of times each individual ONN used each of the note templates.
In the “Act” phase, outcomes were shared internally via presentation with the cancer center leadership, the pharmacy team, and the cancer quality team, which included physician leaders. Additionally, a continuing education credit presentation was offered to all oncology nurses across the system.
Preimplementation chart audits of documentation indicated that 12% of patients (n=50) started on an oral oncolytic received initial education specifically by an ONN. Follow-up was completed by an ONN 8% (n=50) of the time.
Overall, throughout the implementation time frame, 32% of ONNs (n=34) utilized the oral oncolytic initial teaching note template and 50% of ONNs (n=34) utilized the oral oncolytic follow-up note template (Figure 1).
During the implementation time frame, 264 patients initiated an oral oncolytic. The initial patient education note template was completed on 122 occasions, indicating that 46.2% of patients (n=264) received education prior to starting an oral oncolytic. See Figure 2 for monthly breakdown.
The follow-up note template was completed 84 times, indicating that 31.8% of patients (n=264) received follow-up within the first month of initiating a new oral oncolytic agent. See Figure 3 for monthly breakdown.
Although there is still room to increase compliance, great improvements were made to nursing involvement in the management of oral oncolytic therapy. Over the course of the evaluation period, initial patient education was completed for 46.2% of patients started on an oral chemotherapy compared with 12% at baseline. Similarly, follow-up was completed for 31.8% of patients during the evaluation period compared with 8% at baseline. When compliance was questioned during the implementation period, feedback from ONNs revealed the tools put in place, such as the tracking report, note templates, and Oral Chemotherapy Education Sheets, were easy to use and helpful. However, the ONNs expressed the greatest barrier to completing the necessary patient education and follow-up was lack of time given increased patient volumes, limitations in staffing, and competing initiatives. Recognizing the importance of ONN oversight of patients receiving oral oncolytic therapy and the need to adhere to accreditation standards, the cancer center leadership has prioritized evaluating ONN workload and staffing volumes.
As identified in the literature, ONN involvement in providing patient education and follow-up to patients receiving an oral oncolytic agent is critical in improving adherence, mitigating adverse effects, and improving overall outcomes.6,7,12,13,20 In addition, certain accrediting bodies require that patients receive education and routine follow-up.29 Fundamental elements of the ONN role include patient education, symptom management, and care coordination.16 ONNs are at the forefront of care and have the ability to positively impact patient outcomes through managing adverse effects, monitoring adherence, and providing supportive resources. Therefore, priority should be taken to ensure the workload and responsibilities of ONNs allow for functioning in that care capacity.
Although outcomes of this project demonstrated improvement in ONN involvement in the management of patients receiving oral oncolytic therapy, further development of similar tracking and follow-up tools is needed. Additionally, more data indicating the patient impact of ONN involvement in patient education and follow-up with oral oncolytic treatments are warranted. Specifically, it would be important to look at outcomes related to patient adherence, frequency of adverse effects, and overall patient experience.
This relatively simple and low-cost quality improvement project demonstrated improvement from baseline in ONN involvement in providing initial education and follow-up to patients receiving oral oncolytic agents. As more of these agents become a reality in cancer care, continued efforts to maintain close oversight of patients are critical to patient safety and quality. ONNs, equipped with specialized clinical knowledge and resources, are best positioned to provide patients the necessary education and follow-up pertaining to oral oncolytic therapy.
The authors have no relevant disclosures or conflicts of interest.
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