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By Jenna Somers and Jane Hirtle
When in-person research activities at Vanderbilt were put on hold in mid-March due to the COVID-19 pandemic, Sheila Ridner, Martha Rivers Ingram Professor of Nursing and director of the Ph.D. in Nursing Science Program, was the primary investigator on two research studies with oncology patients. Entering its sixth and final year, one of these studies involved working with 1,201 breast cancer survivors throughout the U.S. and Australia to test an intervention for lymphedema prevention using a compression garment. In the other study, Ridner and her team worked with pediatric cancer patients at the Monroe Carrell Jr. Children’s Hospital at Vanderbilt, testing a therapeutic intervention called Child and Parent Yoga (CAPY).
Unlike many research activities that were halted by the pandemic, Ridner’s research did not occur in a library, office or lab on campus. Instead, her laboratories were clinics, patients’ homes and hospital rooms. Close, physical interaction with patients was essential to their care and to achieving the research aims of the studies, so when the pandemic stopped that in-person engagement, it did not just impact the research, but the lives of the participants as well. Even though the pandemic affected some of the studies’ data collections, Ridner’s steadfast commitment to patients ensured that their care did not suffer.
“In the CAPY study, we felt it wasn’t ethical to quit on kids undergoing cancer treatment and their parents when data and reports from participants indicated that the therapy was helpful,” Ridner said. “It was relieving a lot of distress, helping them focus on positive things that they could do as a family unit. We successfully switched to telehealth therapy with the yoga instructor to finish the study with these families, and the success of that taught us that COVID-19 doesn’t have to be a barrier for this kind of treatment.”
Unfortunately, the pandemic forced Ridner’s team to discontinue a final in-person CAPY data collection because, at the time, they could not go to the Children’s Hospital to measure blood pressure, pulse and range of bodily motion. They also could not enroll the additional six to eight new families they had hoped to include in the study before the funding expired on June 30.
Determined to complete the lymphedema study, Ridner and her team forged ahead. “The participants in the lymphedema prevention study had given us five years of their lives, and so we also felt an ethical responsibility to finish our work in supporting them,” Ridner said. “Furthermore, we needed the final data collection to be able to answer the aims of this study that had cost about $8 million.”
In-person research in the international lymphedema prevention study restarted in different phases and in different ways, and because the pandemic arrived in Australia before the U.S., Ridner had to deal with the impact to research sites there first. Fortunately, all sites have now reopened in some form.
In Tennessee, 325 people are enrolled in the study taking place at the Vanderbilt Breast Center at Vanderbilt Health One Hundred Oaks. On June 1, Ridner’s team resumed seeing patients there, and then on July 20, they received permission in Phase II of Research Ramp-up to start visiting patients in their homes or at the School of Nursing site at the Sony Building. Vanderbilt data collection was completed Aug. 24 while other sites are still collecting data.
Since implementing new COVID-19 safety protocols in Phase II, the researchers wore face shields, face masks and either lab coats or gowns with sleeves. They assessed themselves and the patients for possible COVID-19 infection before entering the patients’ homes or clinics. If the patient did not have a mask, the researchers hung one on the front door so that everyone wore protective gear before they made contact. No one but the researchers and patients were allowed in the homes during the visits.
“We conducted physical measurements of patients’ arms—either the volume, the whole arm or fluid levels between cells—assessing them for a compression garment. We then assisted them in putting it on and educated them on wearing and removing it on their own,” Ridner said. “This close-contact care was essential to the health and well-being of these patients, which is why we were eager to return to this work in Phase II and why we welcomed the extra safety precautions.”
The team placed used equipment into biohazard bags before leaving the patients’ homes, and then they disinfected it outside. They threw away disposable coverings and changed into new clothes in their garages before entering their own homes, placing used scrubs into biohazard bags until they were laundered. Without implementing these COVID-19 safety precautions to protect both research participants and the Vanderbilt research team, Ridner and her colleagues would not have been able to continue their critical work during the pandemic.
As medical research professionals working with an immunocompromised population, Ridner’s team was already following strict infection control protocols, so augmenting those procedures during the pandemic came naturally. However, working remotely has presented some challenges.
For the past five years, Ridner traveled annually to Australia to conduct fidelity oversight visits at each research site. Current travel restrictions prevent her from making that trip.
Through Zoom, Ridner and her research nurse provide real-time training and evaluation to partners at sites throughout the U.S. “They Zoom in to show us procedures like how they placed a tape measurement on a patient, and then we double read it with them,” Ridner said. “It’s more time consuming than in-person oversight, but the important thing is that it works, the patients get their care, and the study can progress.”
“When we moved to remote work, we had to set up confidential areas in our homes to talk to study participants on Zoom, or have family members leave the house,” she added. “Not everyone was set up for such a transition, but we adapt and make it work.”
Adaptation has been a motif of Ridner’s research activities in 2020 and the key to overcoming her team’s greatest challenges, but she fervently believes that the presence of COVID-19 should not serve as a deterrent for high-touch research because doctors and nurses are trained to deal with very contagious diseases. “A research study like this benefits people profoundly, and we have the skillsets to conduct it safely,” she said. “Those patients need our care, even during a pandemic.”
As the lymphedema prevention study wraps up, it has already begun to impact changes to patient care. After publishing the interim analysis of the study that showed benefits to early intervention, Ridner, who is on the board of the Lymphatic Education and Research Network, and actress Kathy Bates, who is a spokesperson for the organization, along with The American Society of Breast Surgeons Foundation successfully petitioned the National Comprehensive Cancer Center Network to change their assessment requirements for cancer treatment centers, requiring these centers to start assessing breast cancer patients for lymphedema at every visit. After the study concludes, it may influence more national and international practice guidelines and policies.
This story is part of a series highlighting Vanderbilt University researchers who have returned to in-person research activities on or off campus. More than 3,000 Vanderbilt research personnel, including Sheila Ridner and her team, have returned to in-person research activities through the Research Ramp-up process spearheaded by the Ad-Hoc Research Ramp-up Working Group and the Office of the Vice Provost for Research.