This is a prospective randomized trial designed to investigate a new care model for
patients who suffer from nerve damage from chemotherapy called chemotherapy induced
peripheral neuropathy (CIPN). All participants in the study will report their CIPN
symptoms daily using a website, app or phone for 12 weeks. In one group the data will be
collected and participants will be encouraged to reach out to their treating doctors for
uncontrolled symptoms. These participants' doctors can prescribe any treatment they feel
is appropriate. In the second group, if the symptoms meet the criteria for eligibility
they will receive a phone call from a nurse practitioner either the same day or next day,
depending on the time symptoms were logged. That nurse practitioner will determine the
correct CIPN treatment using an algorithm and prescribe it. The study will track the
severity of symptoms over time as well as looking at the impact on treatments for CIPN
(medications and referrals).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04763356.
Locations matching your search criteria
United States
Virginia
Richmond
VCU Massey Comprehensive Cancer CenterStatus: Active
Name Not Available
This is a prospective single blinded (outcome assessor) randomized controlled trial of a
CIPN care model that pairs a personalized suite of remote symptom monitoring technologies
with triggered real time responses from a nurse practitioner (NP) equipped to enact
algorithmic guideline based CIPN treatment in response to poorly controlled symptoms. The
study will enroll adult cancer patients who have, within the last 540 days, completed a
course of a taxane, platinum, or vinca alkaloid-based agent, bortezomib, thalidomide,
lenalidomide, ixazomib or brentuximab vedotin, or have been receiving ongoing maintenance
therapy with bortezomib, thalidomide, lenalidomide or ixazomib for >90 days, and have
been diagnosed with CIPN. Participants will log neuropathy symptoms daily for a one week
run-in period using a remote symptom monitoring technology described below. Participants
who meet the criteria to proceed in the study will be randomized in a 1:1 ratio to Usual
Care (UC) or Symptom Care at Home with Nurse Practitioner follow up (SCH-NP). Those not
meeting eligibility criteria will be excluded but can be rescreened 6 weeks later. Both
groups will log symptoms daily and receive either UC or SCH-NP care for the 12 week study
period.
The UC group will report daily neuropathy symptoms via the web, app or automated phone
system and will receive usual care for CIPN symptoms from their existing treatment team.
The SCH-NP group will report symptoms similarly but concerning symptoms will trigger a
call back from a nurse practitioner who can provide treatment based on standardized
algorithmic CIPN guidelines.
In person study visits will take place at baseline and 6 and 12 weeks after
randomization. CIPN specific QoL and disability measures, validated CIPN sign scales and
detailed information on opioids, neuropathic pain medications and other CIPN treatments
will be collected at each visit.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Vermont and State Agricultural College