SENSE Study: Remote Symptom Monitoring for Patients With Chemotherapy-induced Peripheral Neuropathy
Completed · Not applicable
Conditions studied: Chemotherapy-induced Peripheral Neuropathy
In brief
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.
Key facts
- Study ID
- NCT05330104
- Run by
- Allina Health System
- People needed
- 12
- Starts
- 2022-01-03
- Expected to finish
- 2025-06-16
- Last updated by the study team
- 2026-01-27
Who can join
Age: 45 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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