How Oncology Nurses Can Contribute to Immunotherapy Clinical Trials
Using the human immune system to target cancer has made tremendous strides in recent years. Jaruska Naidoo, MBBCh, from the Sidney Kimmel Comprehensive Cancer Center, and Joanne Riemer, RN, BSN, from Johns Hopkins University, discussed the progress made in immunotherapy and how nurses play a role in clinical trials during a session at the 42nd Annual Congress in Denver, CO.
Naidoo and Riemer discussed how evaluating and managing immunotherapy side effects are unique and distinct from those related to chemotherapy. Inflammatory processes can affect any organ system, and side effects may be exacerbated by underlying autoimmune conditions or the presence of autoantibodies. Providers should always suspect an autoimmune toxicity, rule out competing diagnoses, identify the toxicity (e.g., diarrhea versus colitis), and grade the toxicity.
They detailed the clinical trial process at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins that has eight inpatient oncology units, an outpatient infusion center that treats approximately 200 patients per day, and radiation oncology on the main campus. Approximately 25% of patients participate in clinical trials, and access to specialist care is available for medical and surgical specialties.
The role of the nurse at the cancer center includes:
- Learn and interpret the study protocol.
- Review and prepare key documents.
- Educate patients about the study schedule or protocol.
- Educate administration team about the study schedule or protocol.
- Consent patients to the study.
- Screen patient eligibility for the study.
- Patient Care
- Manage patients while they participate in the study, including toxicities.
- Communicate with patients, study team, and sponsor.
- Document patient management.
In terms of learning the protocol, nurses should be aware of the study phase, objectives, and drug to be evaluated, as well as inclusion and exclusion criteria to decide if a patient in their care is eligible.
Naidoo and Riemer detailed “lessons learned” in their experience with clinical trials for immunotherapy agents, including prescreening patients to identify those not suitable to receive them, recognizing and grading infusion-related adverse events (irAEs), considering a consultation from the medical specialist for suspected irAEs, and educating patients and caregivers about how the therapies target the immune system to fight cancer, how they can cause inflammation, the side effects, and emergency medical contact information.
They concluded by outlining the recommendations from the National Cancer Moonshot Initiative’s Blue Ribbon Panel for compelling cancer research opportunities:
- Directly engage patients.
- Create a national cancer data ecosystem.
- Create a human tumor atlas.
- Develop new enabling technologies.
- Create a cancer immunotherapy translational network.
- Identify therapeutic targets to overcome drug resistance.
- Improve understanding of fusion oncoproteins in pediatric cancer.
- Develop guidelines for symptom management research.
- Expand the use of precision prevention and early detection.
- Conduct retrospective biospecimen analysis in patients who received standard treatment.