Remote Monitoring and Management of Chemotherapy Induced Peripheral Neuropathy

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Vermont
Study ID
NCT04763356
Status
Recruiting
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Conditions

  • Chemotherapy-induced Peripheral Neuropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Symptom Care at Home with NP follow up — OTHER
    In the SCH-NP group all participants will report their CIPN related symptoms daily via the app, website or phone tree. Any concerning symptoms will trigger a call back from a nurse practitioner who will use a consensus and evidence based algorithm to prescribe therapies for the CIPN symptoms.

Study Details

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).

Key Dates

Start date
Jan 10, 2023
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
422 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Usual Care (UC)
    The UC group (control) models the current standard of care model. The NTSS-6 will be completed daily by participants using the SCH system. The results will not be reported to their oncology team. Participants will be counseled at study entry to contact their treating care team to manage CIPN symptoms. They will also receive a reminder to do so at the end of each reporting session. UC participants will attend all regular visits with these providers and can receive any type of treatment for their CIPN symptoms. There are no limitations on the therapies that can be prescribed, or the means by which the clinical team communicates with the participant. Treating physicians will be provided with links to the current ASCP and NCCN guidelines but will not be provided with the algorithm as this group is meant to reflect current standard medical practice.
  • Experimental: SCH with NP follow-up (SCH-NP)
    Participants will report daily symptom as above. The SCH system will notify the study NP for any of the following symptoms measured by the NTSS6: aching, allodynia, burning, lancinating, numbness, and prickling that are concerning. Participants will receive a NP call back either the same day or the next day, depending on the time they reported their symptoms. The NP will follow a standardized script to elicit details about the CIPN symptoms and recommend and prescribe CIPN treatment per the treatment algorithm.

Primary Outcome Measure

The change in NTSS-6 between the run-in and the 12 week study period. [ Time Frame: 12 week study period ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of UtahSalt Lake CityUtah84112
Samantha Stebleton
[email protected]
801-213-2260
Christina Echeverria, MA
[email protected]
801-585-1598
Kathi Mooney, PhD,RN,FAAN (PRINCIPAL_INVESTIGATOR)
University of VermontBurlingtonVermont05405
Hannah Taylor, BA
[email protected]
802-656-9442
Mary Healey, BA
[email protected]
802-656-9427
Noah Kolb, MD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth University Massey Cancer CenterRichmondVirginia23298
Melanie Crabtree
[email protected]
804-828-3155
Tyler Phillips
[email protected]
804-828-9085
Gordon Smith, MD (PRINCIPAL_INVESTIGATOR)

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