Clinical trial NCT05330104: SENSE Study: Remote Symptom Monitoring for Patients With Chemotherapy-induced Peripheral Neuropathy
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
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient satisfaction with mEMA
timeFrame: Through study completion, up to 6 months
measure: Patient Adherence to mEMA
timeFrame: Through study completion, up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
Study officials:
affiliation: Allina Health
name: Laura Gilchrist, PhD
role: PRINCIPAL_INVESTIGATOR
References: