Oncology APPs Hold Key Roles in Community-Based Clinical Research

December 14, 2023 by Jan Tipton DNP, APRN-CNS, AOCN®

Nearly 65% of oncology advanced practice providers (APPs) say they (https://doi.org/10.6004/jadpro.2021.12.5.2) want to have a larger role in clinical research. Although research has often been a part of the APP role in academic institutions, providers now have the potential to engage in its expansion into community practice settings. Here are some of the key contributions APPs can bring to community-based clinical research. 

Key Role: Enrollment and Education 

Oncology APPs are an important member of the interprofessional team needed to enroll, treat, and monitor patients in clinical research programs. Only 8% of all patients with cancer in the United States enroll in (https://doi.org/10.1177/1740774520901514) clinical trials, and participation is even lower (https://doi.org/10.1188/19.CJON.220-223) among patients who belong to underrepresented groups, have low incomes, or live in rural areas. Every patient—especially older adults, who make up a growing percentage of adults with cancer—should be evaluated (https://doi.org/10.1093/jncimonographs/lgac019) for appropriate clinical trials.  

Oncology APPs have great opportunities (https://doi.org/10.1188/19.CJON.220-223) to establish trusting relationships with patients, guide them to appropriate trials, and promote shared decision-making, as well as address enrollment barriers related to social determinants of health, such as transportation, educational level, health literacy, and financial resources.  

Unfortunately, patient populations in many trials do not represent (https://doi.org/10.1188/19.CJON.220-223) the overall population, and many patients are excluded (https://doi.org/10.6004/jadpro.2022.13.3.6) because of language barriers or lack of culturally sensitive materials. More accurate representation ensures that the information learned from a trial applies to all patients and identifies different considerations for special groups that clinicians must be aware of to provide personalized care.  

Oncology APPs can provide patient and clinician education, raise awareness of barriers, and create and promote resources to make clinical trials more feasible and desirable for patients. They can also help reconcile differences in perceptions among physicians, APPs, the research team, and patients, which may require (https://doi.org/10.6004/jadpro.2022.13.3.7) more individualized education to overcome implicit biases and prevent misunderstanding and miscommunication.  

Key Role: Symptom Management and Monitoring 

Promptly identifying adverse events, documenting accurate and detailed information, and providing feedback to the research staff, protocol sponsor, and patients and caregivers are paramount for good clinical practice and accounting for clinical trial audits. In those areas, oncology APPs set the standard. They also have key roles in symptom management and coordinating evidence-based care for complex patients with multiple comorbidities. Emerging roles may involve using technology (https://doi.org/10.6004/jadpro.2022.13.3.7), such as telemedicine with remote monitoring, for clinical trials consultations and monitoring patients for adverse events once enrolled. 

Key Role: Subinvestigator and Other Leadership     

Another emerging oncology APP role is as a subinvestigator (https://doi.org/10.1188/20.CJON.479-481), working collaboratively and under the supervision of the principal investigator to enroll appropriate patients, establish treatment plans, and provide direct, day-to-day clinical care.  

Oncology APPs can work as (https://doi.org/10.6004/jadpro.2022.13.3.7) a consultant and member of protocol review committees to evaluate scientific merit and feasibility for potential trials in the planning process. In some cases, oncology APPs can serve as (https://doi.org/10.6004/jadpro.2022.13.2.2) principal investigators for cancer prevention, symptom management, and cancer care delivery trials.  

In 2021, under the National Cancer Institute’s Cancer Therapy Evaluation Program, APPs in certain states and institutions became authorized (https://doi.org/10.1200/OP.22.00224) to sign investigational treatment orders and standard-of-care orders without a physician cosignature.  

Some settings include APPs on the interprofessional team involved in translational research (https://doi.org/10.1111/jonm.13496) that takes knowledge from the bench to the bedside and back again, ultimately resulting in implementation in specific populations. APPs can contribute to implementation science, which embeds evidence in specific interventions to improve healthcare delivery and evaluates the outcomes, similar to the approach used for quality improvement. Both types of research require APPs to engage in interprofessional and academic collaboration to develop their role and share their leadership skills.  

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