Published in Overview Articles
APHON is pleased to partner with the Children's Oncology Group (COG) again this year to present a special educational track of sessions that focuses on the care of children enrolled on COG clinical trials.
Are Your Patients with Advanced Cancer Suffering? A Nurse-Led Study Utilizing Technology to Measure Symptoms (C205)
Nurses and nurse practitioners have the opportunity to be at the forefront of supportive care research using current technology. Through collaboration between the COG Nursing Research Subcommittee and Alex’s Lemonade Stand Foundation, a mentored nursing grant funded a multisite study investigating how children with advanced cancer experience symptoms. Minimizing suffering, including effective symptom management, in children with advanced cancer is a central value for pediatric oncology clinicians (Nuss et al., 2005). Patient-reported outcomes have been used in pediatric oncology symptom-related research (Baggot et al., 2012); however the majority of literature specific to symptoms during palliative or end-of-life care for children with advanced cancer is based upon medical record reviews and to a lesser extent, patient self–report (Hinds et al., 2007; Wolfe et al, 2015). The study purpose was to prospectively describe symptom frequency, severity, and distress level in children and adolescents with advanced cancer using patient self-report and parent proxy. Feasibility of gathering data via smartphone technology was also assessed. A modified version of the Memorial Symptom Assessment Scale (MSAS) was used to measure symptoms and was administered to child/parent dyads electronically every 2 weeks. Information regarding disease status and cancer treatment was collected. Data was analyzed using descriptive statistics and regression analysis. A total of 47 children and adolescents and 47 parents participated in the study. The most frequently reported symptoms by children with advanced cancer and parents were pain (n=195/562, 34.70%), lack of energy (n=186/561, 33.16%), and nausea (n=156/560, 27.86%). Presence of disease (P=<0.0001), recent disease progression (P=0.0002), and receiving cancer therapy (P=0.0004) were significant factors associated with pain. High intensity cancer therapy was a significant factor on pain frequency (P=0.0445) and level of distress (P=0.0224). Increased understanding of the symptom experience may promote communication with children and timely intervention which is a priority in nursing practice.
A Tale of Two MABs: Blinatumomab and Inotuzumab in COG Clinical Trials for Relapsed B ALL (C211)
Survival for pediatric patients with relapsed B lineage acute lymphoblastic leukemia (ALL) is sub-optimal. Traditionally, treatment protocols for relapsed ALL have relied on cytotoxic chemotherapy. Despite substantial acute and long-term toxicity, there has been no significant improvement in survival in patients treated on these protocols over the past several decades. Chemoresistance is commonly cited as a reason for treatment failure. Treatment failure is defined as either the inability to achieve clinical remission post-relapse or a subsequent relapse following traditional therapy that includes intensified chemotherapy with or without stem cell transplant. The ideal therapy would be the use of a cellular targeted approach that destroys leukemia cells but spares other cells and improves response and survival while minimizing distressing and sometimes life-threatening toxicities. Early phase clinical trials with the synthetic antibodies Blinatumomab (BiTE) and Inotuzumab (INO) have shown great promise in achieving clinical response in heavily pre-treated pediatric and adult patients with relapsed and refractory ALL. This session will detail the targeted approach of these novel antibodies and their unique mechanisms of action: Blinatumomab modulates the immune system to destroy cancer cells, while Inotuzumab provides a link to deliver cytotoxic treatment directly to the cancer cell. These two novel agents will be compared, including their reported efficacy from early phase trials, toxicity profiles, and administration principles. Highlights from the current COG clinical trials AALL1331 and AALL1621 will be reviewed, with a focus on the uniqueness of each trial, including phase type and eligibility criteria. Additionally, AALL1331 has been activated since December 2014, providing an opportunity to share clinical examples and practical tips regarding the nursing care of patients receiving Blinatumomab.
Therapeutic and Supportive Care Protocols Paving the Way to a Brighter Future for Children with AML: Children’s Oncology Group Experience (C217)
Acute leukemia is the most common malignancy in childhood and acute myeloid leukemia (AML) accounts for 15% of childhood leukemias. Survival for children with AML has improved, but overall survival is limited to 65%–70%. Improvement in survival for children with AML has been achieved by advances in knowledge contributed by various international cooperative group clinical trials. The majority of children newly diagnosed with AML in North America receive treatment on a Children’s Oncology Group (COG) clinical trial. The COG clinical trials for AML have investigated the role of risk stratification and intensification of therapy including the use of hematopoietic stem cell transplant. With the increase in intensity of chemotherapy, the COG recognized the limitations in delivering this therapy due to infection. Bacterial sepsis and invasive fungal infections are the leading cause of morbidity and treatment related mortality in children receiving treatment for AML. To address this challenge, attempts to improve supportive care through COG’s Cancer Control trials have focused on prophylactic antibacterial and antifungal therapies. This session will describe the results of recent AML therapeutic trials with a focus on improved risk stratification using cytogenetic and molecular diagnostics, use of minimal residual disease testing (MRD), and induction response that may contribute to improved outcomes in AML. In addition, results of recent supportive care trials and improved outcomes through decreasing the rate of infectious complications will be discussed. Due to the intensive nature of current AML therapy, the nursing care required for children undergoing treatment is complex and demands specialized knowledge and skill and a team based approach to care. This session will enhance nursing practice by helping nurses to understand the most current AML therapeutic and supportive care protocols and the complex nursing care needs of their patients with AML.
Beyond the Cure: The Children’s Oncology Group’s Efforts to Improve Outcomes for Pediatric Cancer Patients Long after Treatment has Finished (C223)
Childhood cancer survivors are living longer than ever before, with overall survival rates exceeding 80%. As a result, survivors also are living with chronic late health effects related to their curative treatments, with 40% of survivors experiencing a severe, disabling, and life-threatening or fatal late effect at 30 years post-treatment. Late effects may include second malignancies, endocrinopathies, cardiomyopathy, infertility, pulmonary function deficits, renal/ocular/auditory disorders, neurocognitive deficits, and metabolic syndrome. Recent studies report that cumulative incidence of late effects may be even higher than previously reported, with survivors having 3 to 5 treatment-related chronic health conditions by the age of 50. This evidence makes it clear that survivors need specific education regarding their unique risk for late effects. Early detection through screening and prompt intervention and treatment is vital in order to minimize the burden of late effects which can negatively impact the survivor’s quality of life. Substantial data regarding the late effects of traditional chemotherapy and radiotherapy is now available, yet little is known about the long-term risks of more modern therapies, including precision medicine and targeted treatments such as immunotherapy and antibody therapy. This session will use survivor-specific exemplars to examine treatment-related exposures and potential subsequent late effects. The newly updated Children’s Oncology Group (COG) Long-Term Follow Up Guidelines will direct these surveillance recommendations. Finally, the most recent long-term follow up study from the COG, ALTE15N2 – Late Effects After High Risk Neuroblastoma (LEARHN), will be highlighted, as this is among the first studies aiming to understand more about contemporary treatments, on the background of intensive chemotherapy, radiotherapy, and transplant.
COG Clinical Trials: Empowered Nurses the Key to their Success (C229)
In pediatric oncology, clinical trials are conducted to improve survival rates, understand disease biology, and prevent or improve management of treatment-related acute and long-term side effects. The majority of children newly diagnosed with cancer in North America are treated on Children’s Oncology Group (COG) clinical trials. In the last 50 years clinical trials in pediatric oncology have increased the overall 5-year survival rate from under 10% to over 80% today. Nurses are an integral part of the success of these trials. Understanding the complexity of these trials is vital to the care of patients and families with cancer. This session will provide a brief overview of the Children’s Oncology Group and the history of clinical trials, review COG protocol navigation, and present key components of delivering care to patients enrolled on clinical trials. Phases of trials, regulatory requirements, informed consent, and principles of good clinical practice, including nursing documentation, will be discussed. Practical implications for nurses caring for patients on clinical trials will be presented and exemplars of nursing and family experiences will be shared. This session will help prepare the nurse to manage increasingly complex clinical trials and deliver excellent cancer care to patients and families enrolled on clinical trials.
Are You an APN Searching for COG Supportive Care Guidelines? COG Guideline Development/Endorsement Process with Practical Applications (C234)
Since the 1970s survival rates for most types of pediatric cancer have continued to improve, with about 80% of patients now expected to become long-term survivors. However, this incredible success requires intensive treatments that are often associated with significant acute and long-term side effects. These side effects of pediatric cancer therapy can negatively impact a patient’s symptom experience and quality of life. Lack of effective symptom management can potentially impact outcomes through delays in proven curative treatments, dose reductions, and patient nonadherence to the treatment plan. Many treatment-related symptoms, however, can be palliated, and a substantial body of evidence-based research exists to provide guidance regarding best practices for prevention and treatment of these symptoms. Advanced practice nurses (APN) often are the providers central to educating and counseling patients and families and prescribing treatments for symptom management. Clinical practice guidelines (CPGs) are rigorously-developed recommendations based on existing literature and synthesized through a well-defined process. The Children’s Oncology Group (COG) has created a committee tasked with identifying, appraising, and endorsing relevant and well-developed CPGs for the prevention and management of common side effects experienced by pediatric cancer patients receiving therapy on clinical trials. The purpose of this session will be to provide APNs with an overview of the guideline development process, introduce the current portfolio of COG-endorsed guidelines, and examine the practical application of these CPGs in pediatric oncology settings. Case scenarios will be woven throughout the session, and interactive teaching methods will be utilized.