Clinical trial management is a special field of nursing, and one that can have a major impact on the improvement of cancer care, explained Elizabeth Panora, NP, a nurse practitioner at Memorial Sloan Kettering Cancer Center.
Panora recently discussed the important role that oncology nurses have in conducting clinical trials at the 38th Annual CFS Virtual, Interactive Meeting.
Clinical Trial Nurse
“According to the National Institutes of Health, [clinical trial nursing] is a nursing specialty that focuses on the care of research patients, and it involves coordinating clinical care, assuring patient safety, ongoing maintenance of informed consent, integrity of protocol guidelines, accuracy of data collection, recording, and follow-up,” Panora said.
When clinical trial nurses first meet patients that will be participating in the study, they review the consent in full so that the patient is fully aware of what the trial will entail. They go over schedules and protocols, and conduct pre-screening biopsies, if needed. The nurses also discuss the financial aspects of the trial, including which parts will be covered by the trial, what will be covered by insurance, and what out-of-pocket expenses may be.
“It’s important to relay to the patient – as well as the caregiver who is responsible for taking care of the patient [at home] – [the importance of] bringing them to appointments and potential adverse events,” Panora said.
Clinical trial nurses must also help to coordinate different members of the care team, such as dermatologists in the case of a skin adverse event (AE).
To prevent any future toxicities, it is crucial that clinical trial nurses talk to patients about any supplements, vitamins, or other drugs that they are taking.
“It’s important to ensure that medications and supplemental vitamins do not interfere with protocol treatment,” Panora said. “We have to cross-reference the protocol guidelines to ensure that medications are not prohibited while on the study.”
Also on the clinical trial team are treatment nurses, who administer the therapy, draw blood, conduct EKGs, and handle acute AEs.
“So if we have a patient who has a treatment reaction, they’re the first ones there. They start to implement the standard [AE management] and they communicate with us,” Panora said, noting that treatment nurses are also in charge of documentation, including the pharmakinetic documentation that is required for most clinical trials.
Communication between the treatment nurses and clinical trial nurses is imperative, so that documentation and patient results can be as accurate as possible.
In addition to AEs, treatment nurses should tell trial nurses about dose changes and psychosocial issues that patients have.
“It’s all about communication,” Panora said.
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