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Remote Monitoring for Peripheral Neuropathy (SENSE Trial)

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 6 months

Awards & highlights

SENSE Trial 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.Check my eligibility

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.See study design

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.

SENSE Trial 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.

SENSE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient Adherence to mEMA

Patient satisfaction with mEMA

SENSE 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Allina Health SystemLead Sponsor

56 Previous Clinical Trials

1,175,174 Total Patients Enrolled

Laura Gilchrist, PhDPrincipal InvestigatorAllina Health

Ginger Carroll, MS, OT/LPrincipal InvestigatorAllina Health

Media Library

Mobile Ecological Momentary Assessment Clinical Trial Eligibility Overview. Trial Name: NCT05330104 — N/A

Peripheral Neuropathy Research Study Groups: mEMA Arm

Peripheral Neuropathy Clinical Trial 2023: Mobile Ecological Momentary Assessment Highlights & Side Effects. Trial Name: NCT05330104 — N/A

Mobile Ecological Momentary Assessment 2023 Treatment Timeline for Medical Study. Trial Name: NCT05330104 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants involved in this trial?

"Affirmative, the clinicaltrials.gov page shows that this medical trial is recruiting participants at present. This clinical experiment was first advertised on March 1st 2022 and has since been updated April 8th 2022. Currently, 40 patients are needed to take part in the study from one location."

Answered by AI

Are there any available patient positions in this experiment?

"As per information located on the clinicaltrials.gov website, this medical trial is open for enrollment. The initial posting date was January 3rd 2022 and the most recent update was published April 8th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SENSE Study: Remote Symptom Monitoring for Patients With Chemotherapy-induced Peripheral Neuropathy

Ginger Carroll 2022. "SENSE Study: Remote Symptom Monitoring for Patients With Chemotherapy-induced Peripheral Neuropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05330104.

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