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Remote Monitoring for Peripheral Neuropathy (SENSE Trial)

N/A

Waitlist Available

Led By Laura Gilchrist, PhD

Research Sponsored by Allina Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 45 years old

New cancer diagnosis other than a primary brain tumor

Must not have

Individuals who started their chemotherapy regimen greater than 4 weeks prior to study enrollment

Individuals being treated for a primary brain tumor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether early lower extremity CIPN symptoms can predict which cancer patients being treated with neurotoxic chemotherapy are at risk for falling.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this study focuses on monitoring symptoms rather than testing a drug, there are no direct side effects from interventions. However, participants may experience the discomfort of CIPN as part of their ongoing chemotherapy treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 45 years old or older.

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My cancer diagnosis is not for a primary brain tumor.

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I am prescribed a taxane or platinum-based chemotherapy for my cancer.

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I can walk without any help from devices like canes or walkers.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I started my chemotherapy more than 4 weeks ago.

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I am being treated for a brain tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient Adherence to mEMA

Patient satisfaction with mEMA

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: mEMA ArmExperimental Treatment1 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.

0 / 6Eligibility criteria met