Have you ever seen chemotherapy or biotherapy administered by a nurse and marveled at how it prevents, reduces, or even cures cancer? Welcome to the outcome of oncology clinical trials! Recognized as its own nursing subspecialty, the oncology clinical trials nurse (OCTN) plays an integral role in cancer research. The Oncology Nursing Society (ONS) put forth nine competencies that guide the OCTN in this exciting and cutting-edge nursing role. As a former OCTN, I will review each competency as it related to my daily nursing practice in a community-based research department.
First Things First
A clinical trial is a research study offering patients a new device or investigational drug (ID); I will be focusing on the latter in this article. Since the ID is not FDA approved, the treatment is considered experimental. Patients use oncology clinical trials to access new medications that otherwise would not be available to them. Some of these trials focus on preventative medicine, whereas others hope to increase overall survival or progression-free survival. The ID can be administered as a single agent (alone) medication or in combination with standard of care (SOC) treatment. And yes, some clinical trials use placebos to determine the efficacy of their ID. There are four phases to a clinical trial. Most community-based research programs only offer phase II-IV trials due to the complexity and staffing needs required to implement a phase I trial. You can visit cancer.org to learn more about the phases of oncology clinical trials. Now, in no specific order, here are the nine OCTN competencies and how they influence clinical trial management.
#9 Ethical Standards
The OCTN is tasked with ethical assessments from the moment they meet and consent a clinical trial patient until that person comes off the research study. The OCTN maintains ethical guidelines by:
Ensuring protocol comprehension: Confirming the patient is of sound mind and understands the risks of participation is essential to ethical integrity. I worked with a physician once who would consent any breathing patient to a clinical trial, even if it was not in the patient's best interest. Despite having a strong desire for a person to be eligible for a study, the OCTN must advocate for the person's safety no matter the outcome.
Guaranteeing impartiality: Remaining neutral while presenting the study information prevents issues such as coercion and coaxing. Persuasion is unethical and should never be used to influence clinical trial participation. I assured my patients they would receive the same excellent care should they choose not to participate in the study.
Providing exact details: It's imperative to be transparent about the additional time commitment, extra doctor visits, multiple lab tests, added procedures, and increased research study costs. I made mock calendars and budgets for patients so they could visualize the added obligations of participation.
Documenting the truth: The OCTN must disclose adverse events (AEs) even if it results in discontinuing the ID, keeping in mind that any data not reported or under-reported impacts the trustworthiness of the trial. Over the years, I have had several patients minimize their side effects out of worry they would no longer be able to participate in the study. I found, however, that completing a thorough medical history before treatment helped decipher what symptoms were new or worsening, reducing the under (or over) exaggeration of AEs.
#8 Informed Consent
Before consenting the patient an evaluation of health literacy, cognitive capacity, and language spoken must occur. The OCTN is responsible for:
Evaluating for compliance: Anyone with a history of gross non-compliance may not be a good study candidate as there are multiple appointments they will need to attend. Additionally, folks with untreated mental illness or substance abuse disorders should not be considered for a clinical trial. Their perception of health could be unreliable, resulting in false data collection.
Offering proper communication: It's mandatory to conduct the consenting process in the patient's primary language. Using a medical translator to explain the trial and providing the consent in their primary language is also obligatory. I once had to have the drug sponsor create a consent in Mandarin, a first for our small research department.
Assessing health literacy: Despite what language a patient speaks, the OCTN must present the study information in an understandable fashion. As a general rule, providing materials written at a 7th-grade reading level is suitable. Having the patient 'teach back' what they have learned is another way I confirmed their comprehension.
Sign on the dotted line: Once the patient is deemed competent and fully informed, the PI and the patient can sign the consent. The patient should always receive a copy of the consent along with supportive documents.
Reconsent as needed: The OCTN is also accountable for reconsenting the patient throughout the study if any amendments are made to the original forms.
#7 Protocol Compliance
Every research study has a set of policies and procedures called a protocol. This protocol is unique to each study and must be strictly followed; it is non-negotiable. The OCTN must implement all protocol elements by
Having in-depth knowledge of each policy and procedure: When a new trial opened, I would study, highlight, and tab essential sections of these guidelines. Using the 'ctrl F' function on the keyboard was a lifesaver if a digital protocol was provided.
Following the protocol entirely: If a patient needs to have a hemoglobin of 10.0 to participate in the trial but has a count of 9.9, they are not eligible, period. Over the years, many PIs provided me lengthy explanations about why they disagreed with the protocol; I patiently listened and then reminded them that their opinion is null and void, although they made valid points. Telling a hopeful patient they did not qualify due to one lab result, or a tumor not being big enough, or their disease is too advanced can be difficult for an OCTN. Without these rules, however, clinical trial data would be inconsistent and untrustworthy.
Reporting missed data points: Forgetting to draw a magnesium level before administering the ID or performing triplicate EKGs two minutes apart instead of five minutes apart are two examples of errors I made as an OCTN (the list is much longer than that!). It never feels good to make mistakes, but they must be reported to the drug sponsor when it happens.
Creating the dreaded CAPA: Errors are assigned deviations from the drug sponsor. Deviations are not a one size fits all punishment; they come in minor deviations and major deviations. Too many deviations can result in an FDA audit, and the site can be shut down. Each deviation results in a Corrective and Preventive Action Plan (CAPA) written and updated by the OCTN, as if admitting to the blunder wasn’t bad enough.
Remaining the expert: Since PIs in a community-based research department are rarely given dedicated research time to study the protocol, the OCTN is relied upon to know the study rules and assist the PI in executing those guidelines.
#6 Recruitment and Retention
The truth is, clinical trials make money for hospitals and clinics, resulting in pressure to recruit and retain study participants. The OCTN meets these requirements by:
Being a modern-day detective: Identifying folks whose cancer has progressed or not responded is key to clinical trial participation. Many research studies only offer their ID once a patient has failed standard of care therapies, so catching these folks before starting a new regimen is vital for recruitment. By reviewing the PIs schedule daily, attending tumor boards where patient cases are presented, and advertising with brochures and posters, the OCTN is sure to find eligible clinical trial participants.
Retaining and maintaining: What good is it to sign patients if they quit due to barriers of care, side effects, or poor communication? Partial data collection leads to incomplete statistics; therefore, working closely with patients to remain on the study is critical. As nurses, we think outside the box and employ resources that mitigate obstacles to care. For example, referring patients to the social worker for help with rides, gas, or lodging, having the financial counselor arrange payment plans, or offering support through massage therapy, yoga, acupuncture, nutrition, and support groups are ways to keep patients motivated to stay on study.
Preventing dropouts: Some drug sponsors limit the number of 'dropouts' a site can have. Withdrawing a clinical trial from an organization that exceeds the dropout number is an unfortunate consequence that the research department, at all costs, should avoid.
#5 Clinical Trial Management
Now for the fun part, delivering patient care! Each protocol is equipped with a schedule of assessments needing precise implementation. The OCTN accomplishes these tasks through:
Attention to detail and efficient care coordination: The schedule of assessments outlines what and when specific procedures need to be done; this may sound simple, but it requires a great deal of work. Although complex and intricate, I reveled in the challenges of meeting the protocol conditions.
Execution of the terms: Some OCTNs provide clinical care by doing EKGs, accessing ports, performing lab draws, and giving medications. Other OCTNs are non-clinical and coordinate those procedures with ancillary departments. Although I found joy in providing hands-on care, the flexibility of this role allows for nursing autonomy.
Acting as the patient representative: Since study patients must report every new side effect, the OCTN is often their main point of contact. Having the ability to triage adverse events (AEs) appropriately requires comprehensive knowledge of both the ID and the protocol. Most studies use the Common Terminology for Adverse Events (CTCAE) to grade symptoms, and that grade determines how symptoms are managed. Communicating this information to the PI promptly is crucial to protocol compliance and patient safety.
Ongoing patient education: Many new clinical trial medications are oral and require drug dosing diaries to be completed daily. Therefore, the OCTN educates patients on the importance of taking ID correctly and documenting that administration.
Ongoing staff instruction: Some OCTNs will perform education with the infusion nurses who administer intravenous ID. Elements like the length of the infusion, the order of infusion, side effect management, and mechanism of action should be included in these teachings.
Consistent interdisciplinary cooperation: Communicating with ancillary staff about specific study requirements is essential to maintaining protocol integrity. For example, many studies require Recist 1.1 to be used to evaluate CAT scan imaging, and this necessity needs to be relayed to the radiologist. The OCTN creates processes for these communication flows to ensure protocol reliability.
#4 and #3 Documentation/Information Management
These two are combined because they go 'hand in hand' (my attempt at a pun). Once the OCTN has performed all procedures on the schedule of assessments, it must be documented for the drug sponsor's data analysis team to evaluate. These duties include:
Documenting and documenting some more: Electronic data capture systems (EDCs) are study-specific portals used to input the data collected by the OCTN. Some research departments have data coordinators that transcribe protocol-required procedures into the EDC, but the OCTN does this part in many cases. For example, imagine you hand-wrote all your nursing notes for an entire shift, then at the end of the day had to rewrite them electronically; this is how the EDC documentation works. The OCTN prints off the supporting documentation (labs, imaging, vital signs, dictations, etc.), provides this data pack to the data coordinator or enters the data herself. This was my least favorite activity as an OCTN. Double charting is never fun. In addition to documenting in the EDC, the paper forms must be filed in a binder for review by the study medical monitor during an audit.
Following strict writing guidelines: The documentation instructions for all clinical trial staff are comprised of writing guidelines called ALCOA +, and the acronym stands for attributable, legible, contemporaneous, original, accessible, complete, credible, consistent, and credible. This type of charting will be taught during the onboarding process to a new study opening. If not followed correctly, deviations can be accrued.
Maintenance of records: Since every clinical trial patient must be monitored closely for side effects, the OCTN must keep adverse event (AE) logs. These logs include start dates of the new/worsening AE, stop dates, the reason for the occurrence, the grade of the AE, and what the AE was related to. Even if the AE is not associated with the ID (broken finger due to being slammed in a car door, for example), it must still be reported to the drug sponsor. Concomitant medications are handled the same way.
#2 Financial Stewardship
A surprising fact about clinical trials is that they are not free. The OCTN plays a significant role in ensuring financial integrity is upheld through the following obligations:
Budget awareness: Although the ID is provided at no cost, many standard of care procedures and medications will be billed to the patient or their insurance company. Therefore, having a solid understanding of the budget is mandatory for the OCTN.
Prevention of 'double-dipping.' No, I'm not talking about chips and salsa! However, invoicing costs appropriately is vital to preventing financial fraud. For example, suppose a research study pays for patients to have an EKG before treatment, the OCTN must make sure the patient's insurance company is not also paying for that procedure. If so, this is considered double-dipping and could land the research department in big trouble. Therefore, having a streamlined communication process between the research department and the billing department is a must.
Honesty is the best policy: Being completely transparent with the patient before signing the consent can decrease confusion when a request for a co-pay is received, or a bill from the hospital arrives. For patients with no insurance, a clinical trial could cost them a tremendous amount of money. Having the patient work with the financial counselor before study participation can help alleviate any financial difficulties the patient may have.
#1 Leadership and Professional Development
Research is pivotal to advancing cancer treatment, and OCTNs can spearhead that voyage by being:
Trailblazers: OCTNs lead local and regional research-related activities such as shared governance committees, clinical ladder programs, and capstone projects. For example, the capstone project I chose for my master's degree in nursing was advocating for a nurse-led breast cancer survivorship program. After working countless hours with the breast cancer survivorship team, my recommendations were followed, and a nurse practitioner now leads that program.
Mentors: OCTNs inspire and motivate new oncology nurses.
Advisors: OCTNs evaluate and redefine the roles and responsibilities of OCTNs.
Promoters: OCTNs advocate for clinical trials and disseminate results of research studies.
Writers: OCTNs participate in and develop publications related to clinical trials and their impact on the nursing profession.
Modern Day Heroes
Being an OCTN was, perhaps, my most rewarding nursing role yet. The opportunity to offer cancer patients the potential of cure through a research study was a remarkable experience. Of course, some folks felt they were just a guinea pig, but most were honored and excited to participate. Although I believe all cancer patients are heroes, it's my opinion that clinical trial patients exhibit real superpowers!