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CompletedNCT05330104SENSEUpdated Jan 27, 2026

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

An interventional study of Mobile Ecological Momentary Assessment in Chemotherapy-induced Peripheral Neuropathy, sponsored by Allina Health System. Completed at 1 site in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-01-27.

Sponsored by Allina Health System · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
45 Years and older
Sex
All
01

Study 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.

Read the detailed description

Patients who are treated with neurotoxic chemotherapy as part of their cancer treatment regimen often experience lower extremity chemotherapy-induced peripheral neuropathy (CIPN) that causes motor and sensory loss, which increases their fall risk. CIPN is a potential side-effect of many chemotherapy regimens used to treat the most common adult cancers. In fact, CIPN occurs in as many as 90% of cancer patients whose chemotherapy includes taxanes, vinca alkaloids, or platinum agents. The symptoms of CIPN affect balance, which may put patients at-risk for falls. While much of the research in this area pertains to participants with long-standing CIPN symptoms, most authorities explicitly advocate for early monitoring for symptoms of CIPN and for earlier intervention than is currently the standard of care. However, there is little scientific literature that specifies (1) when in patients' chemotherapy regimens these symptoms typically first reach a significant CIPN or fall/near fall symptom threshold, and (2) how to best systematically track symptom emergence. Further, there are no evidence-informed best practices for early identification of CIPN symptoms and grading of severity, nor is there clear information about early time-points for symptom emergence that could inform when clinicians should begin to pay attention to patients' fall risk.

To address this, a team of expert clinicians and researchers from Courage Kenny Rehabilitation Institute (CKRI) and Allina Health Cancer Institute (AHCI) will use a mobile survey system to track the emergence of CIPN symptoms and fall risk over the course of patients' chemotherapy.

02

Conditions studied

  • Chemotherapy-induced Peripheral Neuropathy
03

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. ≥ 45 years old
  2. New cancer diagnosis other than a primary brain tumor
  3. A taxane and/or platinum chemotherapy agent has been prescribed as part of the treatment regimen for cancer.
  4. English speaking
  5. Able to see, hear, speak (with or without assistive devices)
  6. Able to walk without an assistive device - for example: cane, walker, walking stick(s) at the start of cancer treatment
  7. Able to provide own transportation to study visits
  8. Willing and able to commit to symptom tracking three times weekly via mEMA for up to 9 months.
  9. 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

  10. Agree to use personal smartphone to download the mEMA application and respond to application notifications.

Exclusion criteria

Exclusion Criteria:

  1. Individuals who started their chemotherapy regimen greater than 4 weeks prior to study enrollment.
  2. Individuals being treated for a primary brain tumor
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    mEMA Arm

    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

  • BehavioralMobile Ecological Momentary Assessment

    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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Through study completion, up to 6 months

  2. Patient Adherence to mEMA

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

    Time frame: Through study completion, up to 6 months

06

Study locations

1 site
  • Abbott Northwestern Hospital
    Minneapolis, Minnesota 55447, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05330104
Lead sponsor
Allina Health System
Responsible party
Sponsor
First posted
Apr 15, 2022
Start date
Jan 3, 2022
Primary completion
Jun 16, 2025
Completion
Jun 16, 2025
Last update
Jan 27, 2026

Study contacts

Laura Gilchrist, PhD
principal investigator · Allina Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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