SENSE Study: Remote Symptom Monitoring for Patients With Chemotherapy-induced Peripheral Neuropathy (SENSE)
Primary Purpose
Chemotherapy-induced Peripheral Neuropathy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Ecological Momentary Assessment
Sponsored by
About this trial
This is an interventional supportive care trial for Chemotherapy-induced Peripheral Neuropathy
Eligibility Criteria
Inclusion Criteria:
- ≥ 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 Criteria:
- Individuals who started their chemotherapy regimen greater than 4 weeks prior to study enrollment.
- Individuals being treated for a primary brain tumor
Sites / Locations
- Abbott Northwestern HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
mEMA Arm
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Patient Adherence to mEMA
Conduct descriptive analyses (mean, mode, median) to determine adherence rates and patterns for mEMA adherence.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05330104
Brief Title
SENSE Study: Remote Symptom Monitoring for Patients With Chemotherapy-induced Peripheral Neuropathy
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2022 (Actual)
Primary Completion Date
January 3, 2024 (Anticipated)
Study Completion Date
January 3, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allina Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Peripheral Neuropathy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mEMA Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Ecological Momentary Assessment
Other Intervention Name(s)
mEMA
Intervention Description
mEMA is a tool that allows for scheduled or triggered surveys to assess a participant's CIPN symptoms and/or fall risk
Primary Outcome Measure Information:
Title
Patient satisfaction with mEMA
Description
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
Title
Patient Adherence to mEMA
Description
Conduct descriptive analyses (mean, mode, median) to determine adherence rates and patterns for mEMA adherence.
Time Frame
Through study completion, up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 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 Criteria:
Individuals who started their chemotherapy regimen greater than 4 weeks prior to study enrollment.
Individuals being treated for a primary brain tumor
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maxwell J Klaiman, BA
Phone
612-863-4088
Email
Maxwell.Klaiman@allina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Gilchrist, PhD
Organizational Affiliation
Allina Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55447
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxwell J Klaiman, BA
Phone
612-863-4088
Email
Maxwell.Klaiman@allina.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SENSE Study: Remote Symptom Monitoring for Patients With Chemotherapy-induced Peripheral Neuropathy
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