Status:
ENROLLING_BY_INVITATION
SENSE Study: Remote Symptom Monitoring for Patients With Chemotherapy-induced Peripheral Neuropathy
Lead Sponsor:
Allina Health System
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Eligibility:
All Genders
45+ years
Phase:
NA
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, doceta...
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...
Eligibility Criteria
Inclusion
- ≥ 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.
Exclusion
- Individuals who started their chemotherapy regimen greater than 4 weeks prior to study enrollment.
- Individuals being treated for a primary brain tumor
Key Trial Info
Start Date :
January 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 3 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05330104
Start Date
January 3 2022
End Date
January 3 2027
Last Update
July 11 2024
Active Locations (1)
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1
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55447