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

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

— SENSE  

Official title:

SENSE Study: Feasibility of Using Continuous, Remote Symptom Monitoring to Identify and Respond to Early Fall-risk for Patients With Chemotherapy-induced Peripheral Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05330104
• Other study ID #: 1830048-2
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2022
• Est. completion date: January 3, 2025

Study information

• Verified date: March 2023
• Source: Allina Health System
• Contact: Maxwell J Klaiman, BA
• Phone: 612-863-4088
• Email: Maxwell.Klaiman[@]allina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 3, 2025
• Est. primary completion date: January 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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:

1. Individuals who started their chemotherapy regimen greater than 4 weeks prior to study enrollment.

2. Individuals being treated for a primary brain tumor

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Behavioral:
• Mobile 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

Locations

Country	Name	City	State
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Allina Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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