What We Learned When Adjusting Protocols to Conduct Remote Oncology Research

April 27, 2021

When the COVID-19 coronavirus pandemic pushed oncology research to a remote, virtual format, the sudden adjustment was, in many ways, more convenient and more effective, but it also posed several challenges. During a presentation on April 27, 2021, for the 46th Annual ONS Congress™, two nurse researchers shared the lessons they learned when they adjusted their research protocols.

Overcoming the Digital Divide

Kathryn E. Weaver, PhD, MPH, of Wake Forest School of Medicine and Wake Forest Baptist Comprehensive Cancer Center, was leading the Automated Heart Health Application (AH-HA) for Survivors Study when the pandemic began. The study involved 12 clinics across the United States and was designed to conduct most assessments in person, including in-person consent and questionnaires completed in person at the clinic via tablet or paper. The study intervention, an electronic health record-based heart health assessment tool, was also intended for in-person visits with an oncology clinician.

During the pandemic, the research team moved study operations virtually, shifting most assessments to online with accommodations for patients without email or internet access. They also obtained a waiver of consent documentation from the institutional review board to obtain it over the phone or videoconferencing without mailing paper forms. Clinicians also transitioned to use the heart health assessment tool with patients who were completing routine oncology care virtually, which required extra study documentation regarding format of clinic visit, type of technology used, and reason for virtual format.

Weaver found that remote research improved patient access to trials, accommodated research staff working remotely, and improved data entry. However, she identified a digital divide that required extra training and troubleshooting, such as concerns about patient privacy and the absence of some biometric data for patients not seen in person.

And although the remote format may have alleviated geographic disparities, Weaver said, it may also have introduced other disparities, such as additional challenges for non–English-speaking patients or potential bias between patients who are comfortable with online technology and complete study activities online and those who opt for traditional in-person participation, she added.

“Overall, an agile and pragmatic approach allowed our research to continue despite the global pandemic and disruptions in oncology care. Our study sites welcomed the changes and the flexibility,” Weaver said.

Embracing Change and Offering Choices

Randy A. Jones, PhD, RN, FAAN, of the University of Virginia School of Nursing and University of Virginia Cancer Center, shared his center’s experience pivoting to virtual research. The study involved three cancer centers and tested the use of a mobile health decision aid for patients with advanced prostate cancer, a decision partner (support person), and a community patient navigator.

Before the pandemic, the researchers planned for face-to-face accrual and interactions. “Investigators were physically in the clinic. They engaged with the clinicians and other resource healthcare personnel regularly,” he explained. “Participants completed measurements within the clinic using e-tablets.”

Then, COVID-19 arrived in the United States. “Most research that did not focus on life and death had to halt at the beginning,” Jones said. “Investigators could not enter the hospital unless they were considered essential employees, so research staff couldn’t engage face-to-face with clinicians or participants. And patients and support persons couldn’t sit in the clinic to complete questionnaires.”

The team modified the protocol at all three institutions to conduct the research mostly on a virtual platform from the enrollment to completion. The researchers used internet-based mobile measurements, mailed paper questionnaires, and held telephone, text, e-mail, and video discussions among the team and with patients.

“Use of telehealth and mobile health in oncology clinical trials is feasible, appropriate, and will continue to expand,” Jones said. “So nurse researchers must be aware of participants’ comfort level in the use of technology and be prepared to offer choices depending on their comfort.”

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