Remote Monitoring for Peripheral Neuropathy

(SENSE Trial)

Overseen By Maxwell J Klaiman, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Allina Health System

Must be taking: Taxane, Platinum

Disqualifiers: Brain tumor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify early signs of nerve damage in the legs caused by certain cancer treatments that might increase the risk of falling. Researchers use a mobile survey system, known as Mobile Ecological Momentary Assessment, to track symptoms and fall risk, helping to identify patients who might benefit from rehabilitation. This trial suits individuals who have recently started chemotherapy with specific drugs like paclitaxel or cisplatin, can walk without assistance, and are willing to regularly track symptoms on their smartphone. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance rehabilitation strategies for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on patients who are already prescribed certain chemotherapy drugs.

What prior data suggests that this mobile survey system is safe for tracking CIPN symptoms?

Research has shown that using a mobile app to track symptoms is generally safe for patients. Studies have found that monitoring symptoms with a smartphone is easy and well-accepted by patients. No serious side effects have been reported from using this type of app.

The app tracks symptoms of chemotherapy-induced peripheral neuropathy (CIPN), which is nerve damage that can occur during cancer treatment. Since the app mainly collects data, it poses no risk to users. Its primary purpose is to identify early signs of fall risks, allowing patients to seek help before accidents occur.

Overall, this mobile tool provides a safe way to monitor health during cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Mobile Ecological Momentary Assessment (mEMA) for peripheral neuropathy because it offers real-time monitoring of symptoms, which is a significant shift from the traditional methods that rely on periodic clinic visits. Unlike standard treatments that focus solely on symptom management, mEMA provides continuous data collection through a mobile survey system, potentially leading to earlier detection of symptom changes and fall risks. This innovative approach not only enhances patient engagement but also provides a more comprehensive understanding of the condition during chemotherapy, which could lead to better personalized care strategies.

What evidence suggests that this mobile survey system is effective for monitoring fall risk in patients with chemotherapy-induced peripheral neuropathy?

Research has shown that Mobile Ecological Momentary Assessment (mEMA), which participants in this trial will use, can effectively track pain patterns in real-time. This tracking is particularly useful for managing chemotherapy-induced peripheral neuropathy (CIPN). Studies have found that smartphone apps can successfully monitor symptoms like numbness and tingling in cancer patients. These apps help identify early signs of CIPN, which can predict the risk of falls. By using mEMA, patients and doctors can better manage symptoms, potentially reducing the chance of falls while continuing cancer treatment. ^{2 3 4 5 6}

Who Is on the Research Team?

Laura Gilchrist, PhD

Principal Investigator

Allina Health

Are You a Good Fit for This Trial?

This trial is for adults over 45 with a new cancer diagnosis, excluding primary brain tumors. Participants must be prescribed taxane or platinum-based chemotherapy and able to walk unassisted. They should speak English, manage their own transport, commit to thrice-weekly symptom tracking via an app on their smartphone for up to 9 months.

Inclusion Criteria

Owns a smartphone with specified operating system versions

I am 45 years old or older.

I can track my symptoms three times a week for up to 9 months.

Exclusion Criteria

I started my chemotherapy more than 4 weeks ago.

I am being treated for a brain tumor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a mobile survey system to track the emergence of Chemotherapy-Induced Peripheral Neuropathy symptoms and fall risk over the course of their chemotherapy

Up to 6 months

Regular mobile survey assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mobile Ecological Momentary Assessment

Trial Overview The SENSE Study tests if early symptoms of chemotherapy-induced peripheral neuropathy (CIPN) can predict fall risk in patients using mobile ecological momentary assessment (mEMA). The goal is to identify those at risk of falling early enough so they can get help and continue life-saving chemo.

How Is the Trial Designed?

Group I: mEMA Arm Experimental Treatment 1 Intervention

In this arm, participants will be using a mobile survey system to track the emergence of Chemotherapy-Induced Peripheral Neuropathy symptoms and fall risk over the course of the participant's chemotherapy.

Who Is Running the Clinical Trial?

Allina Health System

Lead Sponsor

Trials

60

Recruited

1,178,000+

Citations

1. researchgate.net researchgate.net/publication/396565561_Screening_for_Chemotherapy-Induced_Peripheral_Neuropathy_and_Instability_with_a_Phone-Based_Application_A_Pilot_Feasibility_Study

Screening for Chemotherapy-Induced Peripheral ... Objective: This study aimed to examine the feasibility, acceptability, and initial validity of using smartphone-based ecological momentary ...

2. withpower.com withpower.com/trial/phase-chemotherapy-induced-peripheral-neuropathy-2022-0df51

Remote Monitoring for Peripheral Neuropathy (SENSE Trial) Research shows that using ecological momentary assessment (EMA) can help track and understand pain patterns in real-time, which has been effective in managing ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8406129/

Chemotherapy-Induced Peripheral Neuropathy Detection ... The objective of this cross-sectional pilot study was to assess the feasibility of functional CIPN assessment via a smartphone app in patients with cancer

4. researchprotocols.org researchprotocols.org/2024/1/e59222/

Digitizing Survivorship Care Plans Through the POST- ... This study is among the first to digitize the SCP in a mobile app and test the effects of a mobile health–delivered behavioral health intervention on symptom ...

5. researchgate.net researchgate.net/publication/387395708_Remote_Monitoring_of_Chemotherapy-Induced_Peripheral_Neuropathy_via_NeuroDetect_iOS_App_an_Observational_Cohort_of_Patients_with_Cancer_Preprint

an Observational Cohort of Patients with Cancer (Preprint) In the context of chemotherapy-induced peripheral neuropathy, another group also proposed a smartphone app for neuropathy monitoring, comprising ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05330104

SENSE Study: Remote Symptom Monitoring for Patients ... In this arm, participants will be using a mobile survey system to track the emergence of Chemotherapy-Induced Peripheral Neuropathy symptoms and fall risk over ...