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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to determine the threshold level of lower extremity CIPN symptoms that put patients who have been prescribed a neurotoxic chemotherapy agent (e.g., paclitaxel, docetaxel, oxaliplatin or cisplatin) as part of their treatment regimen for cancer at-risk for falling. The investigators believe that by specifying early CIPN symptoms that predict fall-risk, The investigators will ultimately be able to identify at-risk patients who could be referred to rehabilitative services to prevent injurious falls while enabling them to continue the chemotherapy treatment that could save their lives.

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 data supports the effectiveness of the treatment Mobile Ecological Momentary Assessment for Peripheral Neuropathy?

Research shows that using ecological momentary assessment (EMA) can help track and understand pain patterns in real-time, which has been effective in managing chronic pain and neuropathic pain in other conditions. This suggests that EMA could be useful in monitoring and potentially improving the management of peripheral neuropathy. ^{1 2 3 4 5}

Is remote monitoring for peripheral neuropathy safe for humans?

The studies on ecological momentary assessment (EMA) and wearable devices for pain management, including in people with chronic pain, spinal cord injury, and cancer, suggest that these methods are generally safe and feasible for use in humans. ^{1 2 5 6 7}

How does this treatment for peripheral neuropathy differ from other treatments?

This treatment is unique because it uses remote monitoring through wearable devices and ecological momentary assessment (EMA) to track and manage symptoms in real-time, offering a personalized approach that differs from traditional methods which often rely on retrospective data. ^{1 2 7 8 9}

Research Team

Laura Gilchrist, PhD

Principal Investigator

Allina Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Wearable Devices: Current Status and Opportunities in Pain Assessment and Management. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Time With Diabetes Distress and Glycemia-Specific Distress: New Patient-Reported Outcome Measures for the Psychosocial Burden of Diabetes Using Ecological Momentary Assessment in an Observational Study. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

An Internet-based ecological momentary assessment study relying on participants' own mobile phones: insights from a study with young adult smokers. [2017]

4. Canada pubmed.ncbi.nlm.nih.gov

Digital Pain Mapping and Tracking in Patients With Chronic Pain: Longitudinal Study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Using ecological momentary assessment to evaluate neuropathic pain experienced by adults with SCI: recommendations and participant perceptions. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Are intensive data collection methods in pain research feasible in those with physical disability? A study in persons with chronic pain and spinal cord injury. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Characterizing Breakthrough Cancer Pain Using Ecological Momentary Assessment with a Smartphone App: Feasibility and Clinical Findings. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Smartphone-Based Ecological Momentary Assessment for Collecting Pain and Function Data for Those with Low Back Pain. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

A Novel Combination of Accelerometry and Ecological Momentary Assessment for Post-Stroke Paretic Arm/Hand Use: Feasibility and Validity. [2021]