Implementation and Evaluation of a Clinical Trial Communication Tool for Frontline Clinical Staff.

The safe care of individuals enrolled in clinical trials requires careful communication and coordination between research and clinical staff. An interprofessional team developed a process improvement plan to design, implement.

Ethical Challenges Encountered by Clinical Trials Nurses: A Grounded Theory Study.

OBJECTIVES: To investigate the ethical challenges experienced by oncology clinical trials nurses (OCTNs) during the management of CTs and to examine how they resolve those conflicts. SAMPLE & SETTING: 12 licensed RNs who had been practicing as full- or part-time OCTNs for a minimum of two years at various academic medical centers in the United States. METHODS & VARIABLES: Classical grounded theory (CGT), an inductive methodology used to explore a social process in which little is known and to develop a theory grounded in the data, was used, in addition to CGT data analysis strategies. RESULTS: CGT data analysis revealed the OCTNs' main concern (implementing an undefined job) and the way in which the OCTNs resolve this concern through the process of figuring it out. Figuring it out consists of learning as they go, utilizing their assets, standing their ground, and managing hope. IMPLICATIONS FOR NURSING: Although some nursing research provides examples of ethical challenges OCTNs might encounter in practice, there is little information regarding how nurses manage those encounters. A theoretical understanding of the OCTNs' experiences managing ethical challenges fills a gap in the nursing literature and provides a framework for how OCTNs manage and respond to challenges in professional practice.

Immune-Mediated Therapies in Lymphoma.

OBJECTIVE: To review types of lymphoma, risk factors, and evaluate novel immune-mediated therapies, including side effects and management of immune-mediated toxicities. DATA SOURCE: Published literature, national statistics, and Web sites. CONCLUSION: Novel biologic agents are being developed with the potential to improve outcomes. However, these novel agents pose unique and sometimes serious adverse events. IMPLICATIONS FOR NURSING PRACTICE: The immune-mediated adverse events require a multidisciplinary approach and early identification. It is imperative providers and nurses are educated on the management of the unique toxicities caused by lymphoma treatment.

Lenalidomide plus rituximab (R2 ) in previously untreated marginal zone lymphoma: subgroup analysis and long-term follow-up of an open-label phase 2 trial.

Lack of consensus for first-line marginal zone lymphoma (MZL) treatment and toxicities associated with currently available systemic therapies have inspired evaluation of immunotherapeutic agents yielding robust outcomes with improved tolerability. We previously reported durable efficacy with first-line lenalidomide and rituximab (R2 ) in follicular lymphoma, MZL and small lymphocytic lymphoma with a subsequent long-term follow-up shown here in MZL patients. This phase 2 investigator-initiated study included previously untreated, stage III/IV MZL patients treated with lenalidomide 20 mg/day on days 1-21 and rituximab 375 mg/m2 on day 1 of each 28-day cycle, continuing in responders for ≥6-12 cycles. The primary endpoint was overall response rate (ORR); secondary endpoints were complete and partial response (CR, PR), safety, and progression-free survival (PFS). The ORR was 93% with 70% attaining CR/CR unconfirmed. At median follow-up of 75·1 months, median PFS was 59·8 months and 5-year OS was 96%. Most non-haematological adverse events (AE) were grade 1/2. Grade 3 haematological AEs were neutropenia (33%) and leucopenia (7%), and grade 4 were leucopenia (3%) and thrombocytopenia (3%). Two patients died of secondary malignancies; no treatment-related fatalities occurred. With extended follow-up, outcomes for MZL patients receiving R2 were robust with no unexpected late or delayed toxicities.

Toxicity Management: Development of a Novel and Immune-Mediated Adverse Events Algorithm
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BACKGROUND: Novel immunotherapy and biologic agents are being developed with the potential to improve outcomes and reduce long-term toxicities among individuals with hematologic malignancies. These emerging drugs affect neoplastic cells and the surrounding microenvironment, causing unique immune-mediated toxicities.
. OBJECTIVES: The aim was to develop an algorithm for clinical staff to manage unique toxicities associated with next-generation immunotherapies indicated in the hematologic population, using a system-focused approach.
. METHODS: Data were collected using specific toxicities based on the four major novel biologic classes. Immune-mediated adverse events were reported across studies. Based on published literature, institutional experience, and group consensus, a novel algorithm for managing immune-mediated toxicities was created.
. FINDINGS: The development of this treatment algorithm provides a more streamlined approach for managing common but unique toxicities and improves safety, compliance, patient outcome, and quality of life with novel immuno-oncologic agents.