May 13 2020
The World Health Organization has designated the year 2020 as the International Year of the Nurse in honor of the 200th anniversary of the birth of Florence Nightingale (born May 12, 1820), and appropriately, the month of May is National Nurses Month.
For this issue of our newsletter, we wanted to recognize and celebrate the important contributions that nurses make to global health, particularly during these challenging times. We asked members of the NRG Oncology CTN Committee how they are facing the COVID-19 pandemic and how processes have changed for clinical trials at their institutions.
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Cynthia M. Licavoli, RN, BSN, MA
Cancer Research Nurse
Missouri Baptist Medical Center
Member of Heartland NCORP
St. Louis, Missouri
How has the day-to-day routine at your institution changed due to the COVID-19 pandemic?
I am located in St. Louis and due to local and state mandate of the shelter in place order, our Research Department has been working remotely since March 23. We at first had been going in as needed to the clinic for neuro assessments and blood collections however, with changing recommendations locally and nationally and based on CTEP guidelines, we have shifted to almost all research efforts remotely. Our research team is completing deviation reports and logs as we encounter changes to our patient care. Our patients are continuing to come in for their IV therapy however when appropriate telehealth visits are being done by the treating physician. A couple of our research nurses have been assigned the duty of screening cancer center patients at the hospital entrance for COVID-19 and we are not allowing visitors. Our day-to-day routines are most certainly changing to survival mode. Our research nurses are also being asked to join the nursing pool for assignments across our network however not all of our research nursing staff. At this time, we are holding off on cancer control trial accrual and only accruing to treatment trials.
We have started a new process for our cancer patients, where we will have patients come in one to two days early for a ‘drive through’ lab draw then televisit with the MD the next day to assess for toxicities and review labs then plan to infuse the following day.
What changes have been made related to how your staff conducts their daily practices?
Our site has decided to manage our research efforts remotely at this time. For example, when a QOL evaluation is due we are either scanning to email or mailing a copy to our patients so they can view as we assess by phone. However, if the patient visits the clinic our physicians are handing copies to the patient for follow up by the coordinator. We are also calling our patients in advance of their appointments to assess our patients for side effects and communicating this information with the treating physicians. These are just a couple of ways we are managing during these times.
Are clinical trials on hold right now at your institution/clinic due to the pandemic?
Our clinical trials are not completely on hold however we are not currently enrolling to cancer control trials. We are still evaluating and taking care of our current research patients for all trials however only accruing for our treatment trials at this time.
Are cancer patients who have been enrolled and treated on clinical trials still receiving care at your institution/clinic?
Yes
How does social distancing impact your interactions with patients?
Definitely! We are doing as much by phone and through the MD as possible, if anything is not being done per protocol we are clearly documenting this on our deviation log and preparing deviation reports for each patient reviewed and signed by the treating physician. For example, drug is now allowed to be shipped directly to the patient and perhaps more than one cycle so this is captured on our deviation logs and reports as needed.
Is there anything else you would like to add or offer words of encouragement to other healthcare heroes?
We have been blessed in St. Louis, and by being in the Midwest to have the benefit of the time to get our staff trained and get better prepared for this current situation in order to be ready for the surge due to hit us in the next 2-3 weeks. We have been on lock down for a few weeks and have learned from other countries and our counterparts on the coasts.
THANK YOU for ALL you are doing to assist our patients, family, friends, co-workers, strangers, we will get through this!
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Ingrid L. Block, APRN, CNS
Associate Director Nursing and Study Coordination
Clinical Trials Office
Stephenson Cancer Center
University of Oklahoma
Oklahoma City, Oklahoma
How has the day-to-day routine at your institution changed due to the COVID-19 pandemic?
The non-clinical staff such as regulatory, data and auditing are now working remotely. Clinical research staff are on a rotating schedule between working on site and working remotely.
What changes have been made related to how your staff conducts their daily practices?
Zoom meetings, telemedicine AE and con-med reviews, minimizing face time with patients. Coordinating between remote and site-based teams. Study by study coordination to determine utilization of telemedicine visits in place of protocol directed visits, omission of laboratory tests not done for treatment safety assessments (ie: PKs), direct delivery of oral medications when available to patients.
Are clinical trials on hold right now at your institution/clinic due to the pandemic?
Most of our tissue studies are on hold. We are only enrolling to therapeutic clinical trials at this time
Are cancer patients who have been enrolled and treated on clinical trials still receiving care at your institution/clinic?
Yes.
How does social distancing impact your interactions with patients?
We are completing a large portion of our AE and con-med reviews over the phone. On-site staff will see the patient if further assessment is required.
Is there anything else you would like to add or offer words of encouragement to other healthcare heroes?
We consider the best treatment for cancer patients to be a clinical trial. Our goal is to preserve this option for our patients while monitoring the safety of our patients, our site and our physicians and staff.
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Erin McCaig, RN, BSN
Senior Clinical Research Nurse
Cancer Research for the Ozarks
Springfield, Missouri
How has the day-to-day routine at your institution changed due to the COVID-19 pandemic?
Day to day routine has dramatically shifted. I am only present in the clinic < 2days/week and only a few hours on those days. The goal is to see my current trial patients (most must come in for active treatment) as quickly as possible then go home to complete data entry and screenings.
What changes have been made related to how your staff conducts their daily practices?
See above answer
Are clinical trials on hold right now at your institution/clinic due to the pandemic?
Not currently. However, we are limited as to whom can go on trial due to lab vendors possibly being closed (translational specimens mandatory on nearly every trial), whether imaging is required (no elective imaging and/or echo can be done—most times the scans fall just outside the 28 day window, therefore both insurance and the treating physician can’t order another CT CAP to satisfy trial entry) and conserving resources. Like most small sites, I am the only research nurse. We have one elderly CRA and a new (non-nurse) coordinator, who I am currently trying to orient in the midst of COVID. But the reality is, if I get sick, we have no research program until I am recovered and back to work. Both my director and our PI are aware of this reality and are working diligently to support me.
Are cancer patients who have been enrolled and treated on clinical trials still receiving care at your institution/clinic?
Yes, and we’ve been receiving transfers from Wash U and Barnes because families are unable to commute 3 hours away from Springfield. So that’s added additional burden and workload to our site.
How does social distancing impact your interactions with patients?
Yes
Is there anything else you would like to add or offer words of encouragement to other healthcare heroes?
I hope all coordinators are feeling incredibly supported by their directors and PI’s at this time. I know I am and it’s made all the difference in the world. And I look forward to the day when I can hug my patients again. Some days that is what they need the most, is a warm, kind, hug.
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Anonymous
Clinical Study Coordinator
How has the day-to-day routine at your institution changed due to the COVID-19 pandemic?
All employees are considered essential here so employees are mandated to self-monitor. So my day starts, at home, with a temperature check. If the temp is above 100.4, the employee must stay home and contact occupational health and your PCP. We take our temps 3 times per day, at minimum. We also monitor for physical signs of COVID-19. The degree of PPE use has changed since this has started. It is much more strict now. We are given masks each day that are worn entering the building. Changing of masks depends on if you are sitting at your desk (we do wear masks at our desks) or if you are seeing patients.
What changes have been made related to how your staff conducts their daily practices?
While we were conscientious about handwashing and sanitizer there is more handwashing and use of hand sanitizer. Meetings are being held via webex or teleconference. We still have our in- person interaction however with PPE on and maintaining the social distancing.
Are clinical trials on hold right now at your institution/clinic due to the pandemic?
We have placed on hold accrual to any cancer control, biospecimen/screening, or symptom management trial. This includes CCDR trials. We have also placed NRG-GY022 accrual on hold since that is a PK sampling trial. Treatment trials are looked at on a “case by case” basis. If the trial offers treatment that the patient can’t otherwise get or there are no standard treatment options then they are placed on trial. We still screen for all studies and we are commenting if the person is not being accrued due to COVID -19. LUNGMAP and Alchemist, even though can be considered screening trials, are still available to accrual since they have treatment trials attached.
Are cancer patients who have been enrolled and treated on clinical trials still receiving care at your institution/clinic?Currently most of our patients are receiving treatments and follow up care without deviation.
How does social distancing impact your interactions with patients?
Since the patients are aware of the social distancing mandates nationwide, they are accepting of it. Hugs were a big part of our patient interactions which are not being given now. I know I have to give it thought because giving a hug is automatic. However, the patients and families understand. For me, I think it is the most difficult when giving the person bad news and not being able to give that extra touch.
Is there anything else you would like to add or offer words of encouragement to other healthcare heroes?
I know the media has called this our “new normal.” I don’t agree and find that disheartening that the media believes that we will have to continue the social distancing and other practices long term (if that is what they mean). I believe, as healthcare providers and the general population, we are being diligent for the current circumstances. The truth is that due to healthcare providers' diligence, adaptability, and quick action, we will be back to our way of taking care of our patients with some changes. Everyone be safe.
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Alison M Ivey, RN, MS, OCN, CCRP
Administrative Director
UF Health Cancer Center
Clinical Research Office
Gainesville, Florida
How has the day-to-day routine at your institution changed due to the COVID-19 pandemic?
Yes, all of our research staff transitioned to remote work on March 18. Research Nurses and Study Coordinators do report to the site as needed to manage in person visits however we have limited their exposure to patients and clinical areas to the minimum necessary needed to conduct the visit. We have eliminated any visits or procedures that are for data collection only (i.e. not related to provision of care or safety assessments) and have moved follow up visits to a telehealth format.
Are clinical trials on hold right now at your institution/clinic due to the pandemic?
We suspended new enrollments to non-treatment trials effective March 17. Treatment trials are continuing outside of those that require research specific biopsies at screening. Our hospital system has discontinued all elective procedures which includes biopsies that are not necessary for diagnosis/clinical care.
Are cancer patients who have been enrolled and treated on clinical trials still receiving care at your institution/clinic?
Yes, activities continue for all treatment protocols. On-site activities on non-treatment protocols continue on a case by case basis with most visits now being done remotely.
How does social distancing impact your interactions with patients?
We rely on our clinical providers for the majority of face to face interactions now. Communications have been robust however.
Is there anything else you would like to add or offer words of encouragement to other healthcare heroes?
I am just so very proud of our cancer research community who are still committed to providing these patients with research opportunities in the face of all of this uncertainty and fear. Their courage is helping to keep the light of hope alive for many of our patients who benefit from access to these trials.
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Anonymous
Oncology Research Nurse
How has the day-to-day routine at your institution changed due to the COVID-19 pandemic?
Day-to-day routine has changed in that working from home is encouraged with in-hospital or in-clinic exposure limited to essential needs. It is challenging for me to work from home since I do not have a scanner, fax, printer. I am going into the clinic about 2x/week consolidating my needs.
What changes have been made related to how your staff conducts their daily practices?
Before entering either facility, we have our temperature checked and answer COVID screening questions. Our temperature is checked when we leave each day as well. All staff are required to wear masks while in building. The physicians have the patient sit in far corner of room and conduct the visit from the doorway with door open. Physical exams are done as determined by MD and the door is closed at that time. When I attend an active treatment patient, I stand at doorway maintaining appropriate distance. If I feel the requirements can be met through a phone call, I call the patient the day prior to visit maintaining privacy in my home. I can also communicate via email with certain patients.
Are clinical trials on hold right now at your institution/clinic due to the pandemic?
Our research department did decide to put a hold on clinical trial accruals a couple of weeks ago. I asked our Director if a case by case review for accrual could begin in a couple of weeks. No word yet.
Are cancer patients who have been enrolled and treated on clinical trials still receiving care at your institution/clinic?
All of our active treatment trial patients are receiving care in the clinic where they registered to trial. Several enrolled patients in follow-up have rescheduled their appointments. The clinic has reduced visits to those receiving therapy in large part. The MDs are seeing new patients. I still receive provided drug from NCORP central office and give to pharmacy for mixing as needed.
How does social distancing impact your interactions with patients?
I always wear a mask and stay about 6 feet apart if I can do so. When I need to give them oral provided drug, I am trying to place the recording diaries and the medication in the exam room prior to their being placed in the room. I ask them to leave their used supply and completed diary there when they leave the room. If I have to give them the medication at chair side, I wash hands before and after and give to them with gloves on. Patients understand about social distancing.
Is there anything else you would like to add or offer words of encouragement to other healthcare heroes?
Stay safe for yourself, your loved ones, our patients receiving cancer care, medical providers and every non-medical staff who make the practice operate. Accruals are going to take a hit but we are doing the best we can to meet protocol requirements in a SAFE manner.
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Anonymous
How has the day-to-day routine at your institution changed due to the COVID-19 pandemic?
Census has decreased in the cancer center and hospital. No elective surgeries. Active treatment patient visits are ongoing along with every 3 to 6 months follow-ups. Follow-up greater than 6 months, is being pushed out to May or later. If possible, visits will be conducted via virtual visits.
What changes have been made related to how your staff conducts their daily practices?
Staff are encouraged to work remotely unless there is a need to come into the office for patient management.
Are clinical trials on hold right now at your institution/clinic due to the pandemic?
Screening is ongoing, but enrollment is on hold unless we can prove that enrollment into the clinical trial is more beneficial than Standard of Care treatment and also can minimize exposure. For example, not a lot of biopsies or long stays with PK’s. We must obtain approval through the institution, cancer center, and unit management prior to proceeding.
Are cancer patients who have been enrolled and treated on clinical trials still receiving care at your institution/clinic?
Yes, if they are in active treatment. If possible; virtual visits for long term follow-ups or phone calls. Mailing Oral study drug if applicable. We are consolidating deviations for missed visit, labs, or trial interventions into 1 deviation as opposed to multiple.
How does social distancing impact your interactions with patients?
The study Coordinators are wearing masks and keeping a 3 feet distance and limiting our interaction. No visitors are allowed into the institution. Exemptions include brain cancer, minor patient, disability that would require the need for active caregiver with them.
Is there anything else you would like to add or offer words of encouragement to other healthcare heroes?
"None of us, including me, ever do great things. But we can all do small things, with great love, and together we can do something wonderful." – Mother Teresa
The world is watching as this Pandemic unfolds. The healthcare heroes that are on the frontlines caring for patients, please know that every minute that you are at work you are appreciated and not forgotten. Please stay safe.
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Rebecca Kramer, RN, BSN, CCRC
Clinical Research Coordinator
Geisinger Hazleton Cancer Center
Geisinger Pottsville Cancer Services
Hazleton, Pennsylvania
How has the day-to-day routine at your institution changed due to the COVID-19 pandemic?
Throughout the Geisinger Cancer Institute, day-to-day routine has taken on a whole a new look. No more grab a coffee and let’s go. Roles are changing often daily and often the “hats” we are asked to wear change as we support our global cancer service line.
What changes have been made related to how your staff conducts their daily practices?
As clinical research coordinators, management has worked out a routine where one coordinator is assigned to be in the office daily. Coordinators are rotating to the office for this coverage to reduce exposure to both employee and patients while still providing accessibility for clinical research support to our providers and research patients. Days that are not assigned clinic days are “remote” workdays. This plan has allowed us to continue our current and active treatment patients and has also afforded our clinical trials team to continue working on screening and clinical trial accruals.
Are clinical trials on hold right now at your institution/clinic due to the pandemic?
At Geisinger, all active treatment trials continue as we alternate who is working in the clinic. We continue to maintain treatment trials for our patients who may have no other alternative to treatment for their disease or a clinical trial would afford them an alternative to standard treatment which may improve their outcome or prolong survival. Cancer control and prevention studies are on hold as they are considered non-essential at this time.
Are cancer patients who have been enrolled and treated on clinical trials still receiving care at your institution/clinic?
Yes, see information above. At Geisinger, for some active patients, we are utilizing direct shipment of oral drugs and following the NCI memorandum for tracking deviations related to telehealth/telemedicine alternatives to care. We are tracking deviations, documenting our care in the electronic record, and noting variances related to the COVID19 crisis.
How does social distancing impact your interactions with patients?
At Geisinger, our patients are missing face-to-face contact and, at times, when offered alternatives to clinic visits such as telehealth or telemedicine. Upon contact with the active clinical trials patients regarding “telephone” visits, they ask questions like “will you be there” when the phone visit takes place? Now more than ever, we have found that stability for our patients is central to our care. While the data may be different, human nature and offering routine when we can and words of encouragement is paramount as we work through this crisis.
Is there anything else you would like to add or offer words of encouragement to other healthcare heroes?
To all of our healthcare heroes on the front lines of this disease, we daily want to continue our thanks and appreciation as we all join as one HEALTHCARE family in whatever roles we are asked to play at this time.
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Whitney Jacobson, RN, CCRP, OCN
Research Coordinator Senior - Oncology Clinical Trials
Advocate Aurora Research Institute | Aurora St. Luke's Medical Center
Milwaukee, Wisconsin
How has the day-to-day routine at your institution changed due to the COVID-19 pandemic?
Team members have been working remotely since March 16 with very limited on-campus work. Only 20% of open trial portfolio remains open to enrollment, but in order to enroll to these few exceptions specific criteria must be met and VP of research must approve.
What changes have been made related to how your staff conducts their daily practices?
Bi-weekly teleconferences to discuss updates, issues, and questions. Conducting study visits remotely when possible and collaborating with our providers who are performing virtual visits. Created an electronic medical record Smart Phrase to standardize documentation for COVID-19 related deviations. Temporary modifications to local IRB non-compliance reporting timeframes. Modified consent documentation guidelines issued.
Are clinical trials on hold right now at your institution/clinic due to the pandemic?
Yes – as above. Restrictions implemented March 16 and continue until further notice. Of note, some resources have been diverted to COVID-19 research efforts.
Are cancer patients who have been enrolled and treated on clinical trials still receiving care at your institution/clinic?
Yes – some appointments have been pushed out due to service line guidelines on scheduling treatment vs. follow-up visits, etc.
How does social distancing impact your interactions with patients?
So far it feels less efficient but it’s getting done. There’s been a lot of electronic and phone communications with clinical staff and patients to conduct protocol-specific visits, assessments, and notifications. Patients and team members have been understanding and flexible.
Is there anything else you would like to add or offer words of encouragement to other healthcare heroes?
Take a moment and pause to celebrate Clinical Trials Day on May 20, 2020, and Oncology Nursing Month in May. Use these opportunities to recognize a colleague’s contributions to their profession, network, and engage in professional development. We need to support one another!