Remote Monitoring and Management of Chemotherapy Induced Peripheral Neuropathy (REMOTE-CIPN)
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|ClinicalTrials.gov Identifier: NCT04763356|
Recruitment Status : Not yet recruiting
First Posted : February 21, 2021
Last Update Posted : October 21, 2022
|Condition or disease||Intervention/treatment||Phase|
|Chemotherapy-induced Peripheral Neuropathy||Other: Symptom Care at Home with NP follow up||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||422 participants|
|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 :||October 21, 2022|
|Estimated Primary Completion Date :||April 30, 2025|
|Estimated Study Completion Date :||April 30, 2025|
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.
- 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
- 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.
- 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
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
|Contact: Noah A Kolb, MDfirstname.lastname@example.org|
|Contact: Mary Healey||802-656-9427||Mary.email@example.com|
|Principal Investigator:||Noah A Kolb, MD||University of Vermont|