Chemotherapy-induced Peripheral NeuropathySENSENCT05330104
SENSE Study: Remote Symptom Monitoring for Patients With Chemotherapy-induced Peripheral Neuropathy
A study testing Mobile Ecological Momentary Assessment in people with Chemotherapy-induced Peripheral Neuropathy, run by Allina Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Mobile Ecological Momentary Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2022to 16 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Show all 11Show fewer
- 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.
Who cannot join
- Individuals who started their chemotherapy regimen greater than 4 weeks prior to study enrollment.
- Individuals being treated for a primary brain tumor
Trial locations and contacts
1 site in 1 country.
United States1 site
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55447
About this study
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
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.
Read the 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.
- Being tested
- Mobile Ecological Momentary Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Ecological Momentary AssessmentBehavioural
Also called mEMA
mEMA is a tool that allows for scheduled or triggered surveys to assess a participant's CIPN symptoms and/or fall risk
| Study group | Role | What they receive |
|---|---|---|
| mEMA Arm | Experimental | 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. Receives: Behavioral: Mobile Ecological Momentary Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, up to 6 months
Patient Adherence to mEMA
Conduct descriptive analyses (mean, mode, median) to determine adherence rates and patterns for mEMA adherence.
Measured: Through study completion, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start3 Jan 2022
- Primary completion16 Jun 2025
- Study completion16 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Gilchrist, PhD, Principal investigator, Allina Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330104
- Sponsor's protocol ID
- 1830048-2
- Acronym
- SENSE
- Status last verified
- Jan 2026
- First submitted
- 31 Mar 2022
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05330104
- Acronym / sponsor ID
- SENSE / 1830048-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mEMA Arm | Experimental | Behavioral: Mobile Ecological Momentary AssessmentIn 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥ 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)
Key exclusion criteria (2 listed)
- Individuals who started their chemotherapy regimen greater than 4 weeks prior to study enrollment.
- Individuals being treated for a primary brain tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Ecological Momentary AssessmentAlso: mEMAmEMA is a tool that allows for scheduled or triggered surveys to assess a participant's CIPN symptoms and/or fall risk | Behavioural | mEMA Arm |
Primary outcome
Patient satisfaction with mEMA
Time frame: Through study completion, up to 6 months
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
Time frame: Through study completion, up to 6 months
Conduct descriptive analyses (mean, mode, median) to determine adherence rates and patterns for mEMA adherence.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Gilchrist, PhD principal investigator
Allina Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Ecological Momentary Assessment in people with Chemotherapy-induced Peripheral Neuropathy, run by Allina Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction with mEMA (time frame: Through study completion, up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.