Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Remote Monitoring and Management of Chemotherapy Induced Peripheral Neuropathy (REMOTE-CIPN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04763356
Recruitment Status : Not yet recruiting
First Posted : February 21, 2021
Last Update Posted : October 29, 2021
Sponsor:
Collaborators:
Virginia Commonwealth University
University of Utah
Information provided by (Responsible Party):
Noah Kolb, University of Vermont

Brief Summary:
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 are moderate to severe they will receive a phone call from a nurse practitioner immediately. That nurse practitioner will determine the correct CIPN treatment using a 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).

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Peripheral Neuropathy Other: Symptom Care at Home with NP follow up Not Applicable

Detailed Description:

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 recently completed a course of a taxane or platinum-based agent 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 have at least 1 day with any symptom that is moderate or greater in severity on the NTSS6 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 severity 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 moderate to severe 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 422 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a single blinded (outcome assessor) randomized controlled trial with 2 arms.
Masking: Single (Outcomes Assessor)
Masking Description: The assessor grading the only physician reported outcome measure (TNSc) will be blinded to the group allocation.
Primary Purpose: Supportive Care
Official Title: Remote Monitoring and Management of Chemotherapy Induced Peripheral Neuropathy
Estimated Study Start Date : February 1, 2022
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : February 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 rated as moderate or severe. Participants recording symptoms between 12 am-3 pm will receive a NP call back by 5pm and those between 3pm-12 am will be called the following day. The NP will follow a standardized script to elicit details about the CIPN symptoms and recommend and prescribe CIPN treatment per the treatment algorithm.
Other: Symptom Care at Home with NP follow up
In the SCH-NP group all participants will report their CIPN related symptoms daily via the app, website or phone tree. Any moderate to severe 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.




Primary Outcome Measures :
  1. The change in NTSS-6 between the run-in and the 12 week study period. [ Time Frame: 12 week study period ]
    The Neuropathy Total Symptoms Score is a the NTSS- 6, a well validated patient reported neuropathy specific outcome measure. Scores range from 0 to 21.96. Higher scores denote worse outcomes


Secondary Outcome Measures :
  1. Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Chemotherapy Induced Peripheral Neuropathy 20 (EORTC- CIPN 20): [ Time Frame: baseline, 6 weeks, 12 weeks ]
    The EORTC CIPN 20 is a 20 item CIPN specific quality of life PRO. Scores range from 20 to 80 with higher scores denoting a worse outcome.

  2. The % of participants taking ≥ 50 morphine milligram equivalents (MME)/ day [ Time Frame: baseline, 6 weeks, 12 weeks ]
    MME/day is the CDC recommended method of measuring and comparing opiate use



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Life expectancy ≥ 5 months.
  2. Age ≥ 18.
  3. Completion of taxane or platinum-based chemotherapy for cancer in the last 60 days.
  4. CIPN diagnosis during the recently completed chemotherapy. CIPN diagnosis will be based on the Toronto criteria for Probable Distal Symmetric Polyneuropathy (neuropathy symptoms and signs).
  5. Presence of at least one positive neuropathic sensory symptom on the NTSS-6 ranked as moderate or severe on the day of screening or in the preceding week based on recall.
  6. The ability to speak/ read sufficient English to be able to communicate with study NP over the phone, utilize the App, website and phone tree (all of which are only available in English).

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Expected treatment with another neurotoxic chemotherapy within the 13 week overall study duration (platinum, taxane, vinca alkoid, bortezomib, thalidomide or related drug, or arsenic trioxide).
  2. Presence of a neurological problem that would confound CIPN assessment (lumbar or cervical radiculopathy, or pre-existing neuropathy from another cause such as diabetes).
  3. Intractable cancer pain requiring treatment by a pain clinic.
  4. Concurrent participation in a different CIPN or pain treatment trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04763356


Contacts
Layout table for location contacts
Contact: Noah A Kolb, MD 8028474589 noah.kolb@uvmhealth.org
Contact: Heather Feldman 802-318-1753 heather.feldman@med.uvm.edu

Sponsors and Collaborators
University of Vermont
Virginia Commonwealth University
University of Utah
Investigators
Layout table for investigator information
Principal Investigator: Noah A Kolb, MD University of Vermont
Layout table for additonal information
Responsible Party: Noah Kolb, Principal Investigator, University of Vermont
ClinicalTrials.gov Identifier: NCT04763356    
Other Study ID Numbers: REMOTECIPN1
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: October 29, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases