Remote Monitoring and Management of Chemotherapy Induced Peripheral Neuropathy

NCT ID: NCT04763356

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 422 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2026-07-31

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 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).

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 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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Symptom Care at Home with NP follow up

Intervention Type: 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.

Interventions

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 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

1. Age ≥ 18.

2. Completion of taxane, platinum, vinca alkaloid-based chemotherapy, bortezomib, thalidomide, lenalidomide, ixazomib, or brentuximab vedotin for cancer in the last 540 days, or ongoing maintenance therapy with bortezomib, thalidomide, lenalidomide or ixazomib for > 90 days.

3. Development of CIPN during or within 3 months of the most recently completed chemotherapy or previous neurotoxic chemotherapy for the same malignancy. For patients on ongoing maintenance therapy: Development of CIPN during current neurotoxic chemotherapy with bortezomib, thalidomide, lenalidomide, ixazomib brentuximab vendotin or vincristine. CIPN diagnosis will be based on clinical diagnosis and the Toronto Criteria for Probable Distal Symmetric Polyneuropathy including the upper and lower extremities.

The Toronto Criteria for Probable Distal Symmetric Polyneuropathy is defined as a combination of symptoms and signs of neuropathy including:

1. At least 1 (one) of the following neuropathic symptoms: "asleep numbness", prickling or stabbing, burning or aching pain AND

2. At least 1 (one) of the following: decreased distal sensation, or unequivocally decreased or absent ankle reflexes. (59)

Clinical Diagnosis:

a. Confirmation of CIPN diagnosis by CIPN expert (investigator/co-infestigator based on chart review +/- inperson/virtual interview with examination).

4. 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.

5. 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).

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. Currently receiving treatment at a pain clinic specifically for CIPN pain.

4. Concurrent participation in a different CIPN or pain treatment trial.

5. For women of childbearing potential: Current pregnancy

6. For women of childbearing potential: Unwillingness to use and acceptable form of birth control for the duration of the study. Acceptable forms of birth control include long acting implantable contraception (ie IUDs, Nexplanon), Oral contraception pills, contraception injections, or strict abstinence if it is part of the subject's current lifestyle.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: collaborator

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Noah Kolb

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noah A Kolb, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

University of Utah

Salt Lake City, Utah, United States

Site Status: RECRUITING

University of Vermont

Burlington, Vermont, United States

Site Status: RECRUITING

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Noah A Kolb, MD

Role: CONTACT

noah.kolb@uvmhealth.org

802-847-4589

Mary Healey

Role: CONTACT

Mary.healey@uvmhealth.org

802-656-9427

Facility Contacts

Samantha Stebleton

Role: primary

samantha.stebleton@nurs.utah.edu

801-213-2260

Christina Echeverria, MA

Role: backup

christina.echeverria@nurs.utah.edu

801-585-1598

Hannah Taylor, BA

Role: primary

hannah.taylor@uvmhealth.org

802-656-9442

Mary Healey, BA

Role: backup

mary.healey@uvmhealth.org

802-656-9427

Melanie Crabtree

Role: primary

crabtreemb@vcu.edu

804-828-3155

Tyler Phillips

Role: backup

phillipst5@vcu.edu

804-828-9085

Other Identifiers

REMOTECIPN1

Identifier Type: -

Identifier Source: org_study_id