August 12 2022
After a long time of waiting, we were finally able to resume an in-person NRG meeting. It was a great feeling to be able to see and talk to our colleagues face to face once again. There is nothing quite like personal interaction to energize, encourage, and engage an individual. Let’s all hope it continues.
The PSC Education Working Group did another phenomenal job of putting on an interesting and informative day of learning for the Clinical Trial Nurses (CTN) and Clinical Research Associates (CRA). Thank you to Cindy Licavoli and Lauren Seames for their amazing leadership and organization to plan for both in person and remote learning. Below are just some snippets of the content shared at this meeting.
Jennifer Dill, BS, CCRP from Missouri Baptist Medical Center provided the CRP Site Survey Results. A cross network (NCTN/NCORP) working group with representation from Alliance, NRG and SWOG undertook this research operations initiative with a primary goal to elicit feedback on site’s most pressing operational challenges in several key areas. The survey was sent to Alliance and NRG membership distribution lists in the beginning of the year. Jen reviewed the results with the group. There were well over 500 that participated in the survey leading to 49 recommendations being presented to the NCI for consideration of ways to streamline processes. To continue this discussion please email Jen with any ideas for improvements, examples, or challenges you or your site may be facing at Jennifer.dill@bjc.org
Dr. Thomas George from the University of Florida Health Cancer Center gave an excellent Review of Colorectal Cancer. With colorectal cancer being the 3rd most common cancer for both males and females and the second leading cause of cancer death in the US, it was a very relevant and relatable topic for everyone. Dr. George provided information on incidence, risk factors, screening, staging and treatment. Please make time to review his slides if you missed the presentation (link provided at end), you will be glad you did. Mary Walters, PharmD, BCOP of Advocate Aurora Health followed with her presentation of incorporating clinical research into Precision Medicine. Using a precision medicine approach may allow for more individualized knowledge of the tumor profile which in turn may lead to more targeted treatment options.
Quality Assurance Audits are always an interesting topic. Mary Jo Antonelli, MBA, MHA of the NRG Oncology provided a thorough review of the NRG Quality Assurance audit program. Audits are at least every 3 years so be sure to review the presentation slides so you are well informed and audit ready at all times.
Marcie Ritter, PhD and Kandie Dempsey, DBA, MS, RN, OCN, both NRG Patient Reported Outcomes (PRO’s) compliance officers, tag teamed to provide a presentation about the importance of completing PRO’s. Understanding how clinical trial medications, treatments, and procedures affect the participant are key to developing well tolerated protocols. Two important reminders are to always complete the PRO coversheet even if the PRO was not completed and secondly to review each protocol thoroughly for the PRO schedule. It is important to note that in some cases PRO completion continues even after the start of a new therapy. Review the individual protocol for guidance.
CTSU updates include another layer of authentication for all users accessing the site. Caroline Porter, CTSU Senior Technical Project Manager, provided detailed instruction on how to set up an ID.me account. ID.me went live on July 8, 2022. Current users have one year to obtain an ID.me account and link it to their CTEP-IAM account. New users will need to obtain this from the start. Any user who has not completed the process by July 8, 2023 will not be able to access any NCI systems. As part of the authentication process, you will be required to upload your driver’s license. Caroline’s detailed slide set is available for review (see end of the article).
Cheryl Leow, FORTE Education and Communication Specialist, provided a review of the FORTE Trial, highlighting patient-directed materials released on CTSU in May 2022 as well as social media communications across Twitter, LinkedIn, Facebook, and Instagram (FORTE Study). NRC-CC005 is looking to accrue over 9000 participants, so please review the slides and consider supporting this important trial. Reach out to FORTE@nrgoncology.org with questions on this trial.
Our lunch program on Virtual Human Technology was provided by Eric Cooks, Ph.D and Andrew Maxim, M.Eng. They demonstrated an interesting and unique way of communicating with research participants by using a virtual human similar in sex, race, and culture to the participant. More to come.
During the afternoon, the PSC provided breakout sessions on several topics of interest. Because of the nature of this piece of the educational program it was only provided to the attendees that were able to be in person. However, many slide sets are available for review if you were unable to attend.
Thank you to all of the Research Nurses and CRA’s out there. It is impossible to run a successful program without you. We value your thoughts, ideas, and suggestions for educational programs very much. Please reach out to us at: nrg-psc@NRGOncology.org
For information on the NRG Oncology Clinical Research Coordinator Mentor Program and to obtain Introductory Materials:
https://www.nrgoncology.org/Clinical-Trials/Clinical-Trial-Resources/Introductory-Materials
For slides from any of the PSC educational sessions:
https://www.nrgoncology.org/meetings-resources/meetings/July-2022-semiannual-meeting/agenda-and-session-information/PSC-meeting-resources-july-2022
For those not getting the NRG monthly newsletters please email: info@nrgoncology.org