Abstract Details

Title Remote Monitoring and Management of Chemotherapy Induced Peripheral Neuropathy (REMOTE-CIPN): A Randomized Trial of a Novel Telemedicine Care Model

Topic Neuromuscular and Clinical Neurophysiology (EMG)

Presentation(s) P1 - Poster Session 1 (9:00 AM-5:00 PM)

Poster/Presentation
Number 412

Objective

REMOTE-CIPN is an NCI funded multi-center randomized controlled trial of a novel technology based CIPN care model intended to reduce CIPN symptoms.

Background CIPN is a common and disabling chemotherapy side effect frequently leading to dose reduction, pain, increased fall risk, reduced quality of life and increased health care costs. Symptoms are under reported and treatment often deviates from consensus guidelines including frequent opioid use. We have previously showed that pairing a remote phone based CIPN symptom reporting tool with nurse practitioner (NP) call back resulted in a 75% reduction in moderate to severe CIPN symptoms during chemotherapy. The efficacy of this system following chemotherapy when CIPN symptoms are worst and physician visits are infrequent remains unexplored.

Design/Methods

420 CIPN patients will be randomized across 3 sites (Vermont, Utah, VCU) to 12 weeks of Usual Care (UC) or Symptom Care at Home with NP follow up (SCH-NP). Both groups will report symptoms using the NTSS6 daily via phone, app or website. The UC group will receive standard care through their treating oncologist. In the SCH-NP group, those reporting moderate to severe CIPN symptoms will receive a real time NP call back to provide evidence-based protocolized treatment.

Results The NTSS6 is the primary outcome measure. Secondary endpoints include time to a 1.26 point reduction from the baseline NTSS6 (the minimal clinically important change), change in EORTC CIPN20, and the percentage of participants taking ≥50 mg mean morphine equivalents (MME) daily. Exploratory endpoints include CIPN-RODS, TNSc, daily opiate use (MME/day), and time from moderate/ severe symptoms to therapy, and others.

Conclusions REMOTE-CIPN will evaluate an innovative, telemedicine delivered care delivery model that has the potential to increase patient access to expert CIPN management, particularly for patients in rural and other medically underserved areas.

Authors/Disclosures
Noah A. Kolb, MD (University of Vermont Medical Center) PRESENTER	Dr. Kolb has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abalone Medical. Dr. Kolb has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Disarm Therapeutics. Dr. Kolb has received personal compensation in the range of $0-$499 for serving as a Consultant for Eisana corporation. Dr. Kolb has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion Pharmaceuticals. Dr. Kolb has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for NINDS. Dr. Kolb has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Kolb has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Locks Law. Dr. Kolb has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for walk up law office . Dr. Kolb has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for ralston, pope, diehl. The institution of Dr. Kolb has received research support from National Cancer Institute.
A. Gordon Smith, MD, FAAN (VCU Health System Department of Neurology)	Dr. Smith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Smith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Argenx. Dr. Smith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merz. Dr. Smith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sangamo. Dr. Smith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for US Department of Justice. Dr. Smith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Smith has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Eidos. Dr. Smith has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Lexicon. Dr. Smith has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. The institution of Dr. Smith has received research support from NIH (NINDS, NIDDK). Dr. Smith has received publishing royalties from a publication relating to health care. Dr. Smith has received personal compensation in the range of $0-$499 for serving as a Study Section with NIH.
	No disclosure on file
Joan Skelly (University of Vermont)	Joan Skelly has nothing to disclose.
Zhi-Jian Chen, MD (Miami Cancer Institute/Baptist Health South Florida)	Dr. Chen has nothing to disclose.
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file

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