URCC NCORP

News & Events

URCC19185 BBT Approved

You either don’t have permission to view this content or you need to log in.

Important Coronavirus Information for URCC Research Base Colleagues

Hello Everyone!

All of us here at the URCC NCORP Research Base are sending our very best to each of you, your families, friends, loved ones and colleagues.  We hope that you are all doing well in light of what our nation is experiencing.  We understand that the coronavirus pandemic is putting a large strain on everyone, both personally and professionally.  We know that everyone will need to prioritize the safety of yourselves and family, as well as patients diagnosed with COVID-19 and individuals with other high priority illnesses and needs during this time.  We also understand the strain that this is putting on our healthcare systems and each of you. 

The safety of the third member of our command team (Gary) is of great concern to us all.  With his venerable 76 years on the planet, an immune system beat up by 10 years of cancer treatment and a partially collapsed lung, Gary was strongly urged by everybody he asked to stay as far away from other humans as possible for the time being.  So he, Joan and Charlie his dog are currently manning our remote URCC command outpost on Seneca Lake protecting our southern flank and in communication with the mothership.  We are glad to report all is well at the Seneca Lake command outpost and mothership! 

We are aware that many healthcare facilities are ramping down or in some cases closing all research, while others may not have been affected as dramatically.  At our University,

all clinical research has stopped including enrolling patients on treatment trials.  Our basic science labs are officially ramping down and stopping experiments by March 20th.  As a result we would like to let you know how we are managing things via the URCC NCORP Research Base at this time for our nationwide clinical trials. 

All URCC NCORP Research Base employees are working remotely, given the Federal, State and County mandates we are under in Rochester, to enable social distancing in a unified effort to slow the spread of the coronavirus.  We do not know how long this will last.  We expect minimal impact on the day-to-day functioning of the Research Base. 

The following information is a summary of how the URCC NCORP Research Base is prioritizing our research efforts at this time and doing our part as best we can to continue helping you, while maintaining the safety of our employees, all of you, patients and study participants and easing what burden we can on the healthcare system. 

We will remain open during normal office hours even though all employees are working remotely to help stem the spread of the coronavirus.  All our employees remain available to help you.  Please use all of the same procedures you use normally to contact Research Base personnel for any needs you may have regarding our clinical trials. 

As most of you know NCI, DCP and CTEP, have issued statements and held a live WebEx to explain what is expected of Research Bases, Study PIs and NCORPs in response to the coronavirus pandemic.  We have taken our lead regarding the plans we are putting in place from all of these groups. 

A basic summary of how URCC is implementing these recommendations and how studies are affected at this time is listed below:

  • We are not closing formal accruals to clinical trials at this time.  We understand that many local IRBs may have decided to close accruals and stop all research or have some other kind of procedures in place and we understand this will not be consistent across all our affiliate NCORPs.  We encourage you to contact your local IRB and institutional leadership and follow their recommendations.  
  • If your local institution or IRB is still allowing study enrollment and it is determined to be safe and in the best interest of patients you can still enroll participants on our open trials.  However, it is not expected that any sites have to enroll during this time where other issues have much higher priority.  
  • NCI and URCC appreciate that there will be reductions in accruals given the current crisis.  While some institutions have had to shut down research, others have not.  We will do our best to continue supporting those of you who are still able to continue conducting research, enrolling and supporting participants on our URCC trials. 
  • Recruitment of patients to therapeutic treatment trials and following them on trials has priority. 
  • Primary prevention, symptom management and CCDR trials are not prioritized at this time.  
  • It is suggested that any study visits for participants already on our URCC trials be conducted online or via telephone when possible.  Telemedicine follow ups are acceptable to work with patients.  PROs and other forms can be done via telephone. Please refer to the NCI documents outlining more details about how study procedures can be modified during this time.  The link is provided here https://dctd.cancer.gov/  It is not necessary to submit an amendment to change in person visits to online or telephone visits at this time.  
  • URCC NCORP RB is not accepting biospecimen shipments (i.e., blood or saliva) until further notice because we cannot receive them.  All specimens can remain frozen per study protocols at your sites and shipped at a later date when we are able to receive them again.   
  • Contact the URCC Protocol Coordinator with questions as usual.  You can still enroll sites and participants, order study supplies, hire instructors, complete trainings and complete all other study procedures, however, understand that URCC may need a bit more lead time to get things done on our end, so please notify us as early as possible. 
  • Report any major protocol violations that occur as a result of coronavirus/COVID-19. In some cases participants may have to be removed from the trial. We don’t expect this to happen often, but this needs to be discussed with the Research Base and Study PI.  
  • Do not report any minor protocol violations (e.g., delayed visits, sending study agent to patient via mail or courier rather than in person).  Study coordinators should document these in a note to file.  Sites do not need to notify NCI, the URCC RB or the study PI of these minor violations now.  However, please track them because it is likely that an aggregate report will need to be sent to the Research Base and NCI in the future.
  • Continue to report all Serious and Non-Serious Adverse Events per protocol (this includes patients with COVID-19 who may have to be removed from the trial). 
  • Audits scheduled for the immediate future are cancelled and will be rescheduled.  
  • URCC will not be opening any new studies at this time.  
  • We will be following the direction of DCP and will be working with the CIRB to get more details on each of our studies being conducted nationally in the NCORP network.  As soon as we have any more information, we will pass that along to everyone.  We don’t anticipate that anything will change from what was just said above, but further changes may be possible. 

Additional information for Study PIs and Study Chairs:

  • Concepts in development will still be submitted for NCI review, since this already occurs online. 
  • For any protocols in development that may need to be submitted to NCI late, we will need to notify NCI via the URCC RB.  Please talk with Jacque if you think you need to request an extension. 
  • For study amendments please work directly with Jacque to determine when and how they will be submitted.  

During this time, we will utilize group-wide email blasts only for absolutely essential announcements. Although working remotely, we expect to be able to continue supporting you very well throughout this time.  We will continue to email or call individuals directly if there is a need to contact you regarding study procedures, patient data, questions, etc.  This will help cut down on email overload which can prohibit the effective dissemination of important information. 

Any questions specific to what is outlined above?  Feel free to contact either: 

Dr. Karen Mustian            Karen_mustian@urmc.rochester.edu

Ms. Jacque Lindke           Jacque_lindke@urmc.rochester.edu

As previously mentioned, for regular Research Base Operations related to the conduct of our clinical trials please use the contacts identified on each protocol that you would normally use.  

The safety and well-being of our URCC NCORP Research Base team, which includes all of you and the patients and communities we serve, are our highest priority.  Please be patient with us as we will be with all of you.  The measures outlined above are subject to change as our institutional and NCI policies evolve during this rapidly changing time.  We will send updates when we have something important for you to know. 

For now, keep doing the best job you can do and, most importantly, take care of yourselves, family, colleagues, patients and study participants!  You are an exceptional team of colleagues and we thank you very much for your help and cooperation to make this work.  We sincerely hope that you are all doing ok.  Please let us know if we can be of any help. 

Sincerely,

Karen Mustian, PhD, MPH and Gary Morrow, PhD, MS,

MPIs and Co-Directors, URCC NCORP Research Base

Jacque Lindke

Administrator, URCC NCORP Research Base

URCC at ACSO – Chemotherapy and Exercise: The Right Dose of Workout Helps Side Effects

Researchers at the University of Rochester Wilmot Cancer Institute discovered something simple and inexpensive to reduce neuropathy in hands and feet due to chemotherapy—exercise.

The study, involving more than 300 cancer patients, is to be presented this weekend and honored as a “Best of ASCO” among 5,800 abstracts at the world’s largest gathering of oncologists, the American Society of Clinical Oncology (ASCO) annual meeting 2016.  More than a dozen other Wilmot scientists also were invited to present data at the meeting.

Investigators for the exercise study directly compared the neuropathic symptoms in non-exercisers to the pain among patients who took part in a specialized six-week walking routine with gentle, resistance-band training at home. 

 Read more here: Chemotherapy and Exercise – The Right Dose of Workout Helps Side Effects

URCC NCORP Research Base Awarded $18M for Cancer Control Studies

As a result of longstanding research strength, the Cancer Control & Survivorship program at UR Medicine’s Wilmot Cancer Institute has been selected to receive an $18.6 million, five-year grant for a leadership role in a nationwide clinical research network to investigate cancer-related side effects.

The National Cancer Institute award to Principal Investigator Gary R. Morrow, Ph.D., M.S., is currently the largest investigator-initiated grant at the University of Rochester, and among the top five largest grants received by a UR Medical Center researcher in the past 10 years.

Wilmot is also one of only two cancer centers in the U.S. to be chosen by the NCI as a research hub for NCORP, which stands for the NCI Community Oncology Research Program. With the new NCORP funding, Morrow and his team will design and manage clinical studies that will be implemented nationwide. All of their work, which includes preparing manuscripts for publication in medical journals, revolves around supportive care for patients coping with side effects during and following cancer treatment.

Follow this link to read the full article: UR Awarded $18M for Cancer Control Studies; Grant Among Largest in Decade