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

NCT05330104 | Completed

• 1 other identifier: 1830048-2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (2)

• Patient satisfaction with mEMA

  Administer a mEMA Experience Survey at each in-person fall-risk assessment to obtain information about participant experience with mEMA over the course of the study.

  Through study completion, up to 6 months

• Patient Adherence to mEMA

  Conduct descriptive analyses (mean, mode, median) to determine adherence rates and patterns for mEMA adherence.

  Through study completion, up to 6 months

Study Arms (1)

mEMA Arm

EXPERIMENTAL

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.

Behavioral: Mobile Ecological Momentary Assessment

Interventions

Mobile Ecological Momentary Assessment BEHAVIORAL

mEMA is a tool that allows for scheduled or triggered surveys to assess a participant's CIPN symptoms and/or fall risk

Also known as: mEMA

mEMA Arm

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 45 years old
• New cancer diagnosis other than a primary brain tumor
• A taxane and/or platinum chemotherapy agent has been prescribed as part of the treatment regimen for cancer.
• English speaking
• Able to see, hear, speak (with or without assistive devices)
• Able to walk without an assistive device - for example: cane, walker, walking stick(s) at the start of cancer treatment
• Able to provide own transportation to study visits
• Willing and able to commit to symptom tracking three times weekly via mEMA for up to 9 months.
• Owns a smartphone with one of the following operating system versions:
• iOS 8.0 - 8.4, 9.0 - 9.3, 10.0 - 10.3, 12, 13.3 or later Android 7.0 - 7.1.2, 8.0 - 8.1.0, 9, 10 or later
• Agree to use personal smartphone to download the mEMA application and respond to application notifications.

You may not qualify if:

• Individuals who started their chemotherapy regimen greater than 4 weeks prior to study enrollment.
• Individuals being treated for a primary brain tumor

Sponsors & Collaborators

• Allina Health System: lead

Study Sites (1)

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55447, United States

Location

Study Officials

• Laura Gilchrist, PhD

  Allina Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 15, 2022
• Study Start: January 3, 2022
• Primary Completion: June 16, 2025
• Study Completion: June 16, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)