Remote Monitoring for Peripheral Neuropathy (SENSE Trial)

Palo Alto (17 mi)

Overseen byLaura Gilchrist, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Allina Health System

No Placebo Group

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.

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

I am 45 years old or older.

My cancer diagnosis is not for a primary brain tumor.

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

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

Exclusion Criteria

I started my chemotherapy more than 4 weeks ago.

I am being treated for a brain tumor.

Treatment Details

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.

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.