Mobile Health App for Peripheral Neuropathy

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Neuropathy-causing medications

Disqualifiers: Diabetes, Stage IV cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an app that teaches family caregivers massage techniques to help cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN). CIPN, a nerve problem from cancer treatment, can cause numbness, tingling, or pain in the hands and feet, affecting daily activities like buttoning clothes or driving. The trial includes three groups: one using the massage app, one with a different relaxation program, and one receiving regular care. It suits cancer survivors who finished chemotherapy over six months ago and still experience moderate to severe CIPN, along with their caregivers. As an unphased trial, this study offers a unique opportunity for patients to explore innovative, non-drug interventions for managing CIPN symptoms.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on a medication that causes neuropathy, you may not be eligible to participate.

What prior data suggests that this massage technique is safe for cancer survivors with CIPN?

Research on similar online programs for managing chemotherapy-related nerve pain has shown they are generally safe and easy to use. These programs instruct caregivers on safely massaging individuals with this condition. No major safety issues have been reported with these mobile health tools. Designed to provide safe support at home, they may help reduce stress and symptoms of nerve pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to managing chemotherapy-induced peripheral neuropathy through a mobile health app. Unlike traditional medications or therapies that focus on symptom relief, this app empowers caregivers with step-by-step instructions for manual therapy, promoting hands-on involvement and potentially enhancing patient comfort. The app's innovative use of technology makes it accessible and convenient, allowing caregivers to provide consistent support with relaxation massage techniques. This unique method could transform the way peripheral neuropathy is managed by integrating digital tools with caregiver education for more personalized care.

What evidence suggests that this mobile health app is effective for chemotherapy-induced peripheral neuropathy?

Research shows that using a mobile health app to teach caregivers massage techniques can help reduce symptoms of chemotherapy-induced peripheral neuropathy (CIPN), such as numbness and pain. In this trial, participants in Arm I will access the PNR program, which provides instruction on relaxation massage techniques. Early results suggest this method can improve the quality of life for cancer survivors by easing CIPN symptoms and strengthening the bond between patients and caregivers. Studies have also found that digital health tools can lead to both immediate and long-term improvements in health outcomes. This indicates that the app's massage techniques could effectively manage CIPN symptoms at home. ^{1 2 4 5 6}

Who Is on the Research Team?

Cindy Tofthagen, PhD, RN

Principal Investigator

Mayo Clinic

William Collinge, PhD, MPH

Principal Investigator

Collinge and Associates, Inc.

Are You a Good Fit for This Trial?

This trial is for family caregivers of cancer survivors who suffer from chemotherapy-induced peripheral neuropathy (CIPN). Caregivers will learn massage techniques through a mobile app to help manage CIPN symptoms like numbness and pain.

Inclusion Criteria

I have moderate to severe nerve pain from chemotherapy, rated 4 or higher.

I am not expected to start new chemotherapy during the study.

Must have internet access

Exclusion Criteria

Unstable lymphedema

My cancer is at stage IV.

I am currently taking medication that can cause nerve pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Dyads receive access to the PNR program or comparator program to perform relaxation massage techniques at least three times a week for 12 weeks

12 weeks

Weekly reporting sessions

Follow-up

Participants are monitored for changes in CIPN symptoms and caregiver esteem using various assessment tools

4 weeks

Open-label extension (optional)

Dyads may optionally receive access to the PNR program following the initial 12-week study period

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Mobile Health Application Intervention for Caregiver Instruction in Manual Therapy for Chemotherapy-Induced Peripheral Neuropathy

Trial Overview The study tests if a mobile health application teaching oncology-informed massage can reduce CIPN symptoms in cancer survivors. It compares this intervention with usual care practices, assessing the impact on quality of life and caregiver stress.

How Is the Trial Designed?

Group I: Arm I (PNR program) Experimental Treatment 3 Interventions

Dyads receive access to the PNR program to perform the relaxation massage techniques consisting of site restrictions, pressure restrictions, stroke direction and stroke length at least three times in a week (TIW) over 15-20 minutes for 12 weeks.

Group II: Arm II (attention control) Active Control 2 Interventions

Dyads receive access to a comparator program to perform the relaxation massage techniques at least TIW over 15-20 minutes for 12 weeks. Dyads may optionally receive access to the PNR program following the initial 12-week study period.

Group III: Arm III (waitlist control) Active Control 2 Interventions

Dyads receive usual care for 12 weeks. Dyads may optionally receive access to the PNR program following the initial 12-week study period.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Collinge and Associates, Inc.

Collaborator

Trials

4

Recruited

1,500+

IRIS Media Inc

Collaborator

Trials

4

Recruited

1,200+

Published Research Related to This Trial

The CIPN15 scale, a reduced version of the QLQ-CIPN20, has been shown to be a reliable and valid tool for assessing chemotherapy-induced peripheral neuropathy (CIPN) in patients receiving neurotoxic chemotherapy, with a high internal consistency (Cronbach's α = 0.91).

The CIPN15 demonstrated strong test-retest reliability and responsiveness, making it a suitable patient-reported outcome measure for evaluating CIPN, particularly in patients treated with taxane and platinum-based chemotherapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Search of a Gold Standard Patient-Reported Outcome Measure for Use in Chemotherapy- Induced Peripheral Neuropathy Clinical Trials. Smith, EML., Knoerl, R., Yang, JJ., et al.[2018]

The COPE-CIPN program, a web-based intervention for managing chemotherapy-induced neuropathy, was found to be highly usable and acceptable among participants, with positive feedback on its ease of use and helpful information.

Although symptoms of neuropathy worsened over time in participants undergoing neurotoxic chemotherapy, the program led to a significant reduction in the interference of these symptoms with daily activities, indicating a moderate effect size (d = 0.39) in self-management support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability and Acceptability of a Web-Based Program for Chemotherapy-Induced Peripheral Neuropathy. Tofthagen, C., Kip, KE., Passmore, D., et al.[2017]

In a study of 488 women receiving docetaxel or paclitaxel, 37.3% of dose-limiting chemotherapy-induced peripheral neuropathy (CIPN) events were attributed to paclitaxel, with a significantly higher incidence (16.1%) compared to docetaxel (2.4%).

Women who experienced dose reductions or treatment discontinuation due to CIPN received significantly less cumulative chemotherapy than planned, indicating that CIPN can impact treatment effectiveness and necessitates further investigation into its implications on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of chemotherapy-induced peripheral neuropathy on treatment delivery in nonmetastatic breast cancer. Speck, RM., Sammel, MD., Farrar, JT., et al.[2022]

The PeriVib is a novel portable test platform that effectively measures vibratory sensation thresholds in patients with peripheral neuropathy, showing a strong correlation with the established Biothesiometer device.

In a study of 28 subjects with chemotherapy-induced peripheral neuropathy, the PeriVib demonstrated its ability to provide quick and reliable assessments, taking only about 5 minutes to complete, making it suitable for both clinical and home use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and evaluation of a portable smart-phone based peripheral neuropathy test platform. Jacobs, PG., Hanaway, P., Leitschuh, J., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06945380

Study Details | NCT06945380 | Evaluating a Mobile Health ... An mobile health application (app) for caregivers can teach care for CIPN using safe oncology-informed massage techniques at home.

2. reporter.nih.gov reporter.nih.gov/project-details/10482557

collinge, william b. - NIH RePORTER This project will develop a mobile health (mHealth) app to empower caregivers with knowledge, skills, self-efficacy and motivation to support loved ones with ...

3. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/chemotherapy-induced-peripheral-neuropathy

Chemotherapy-Induced Peripheral Neuropathy Clinical Trials The purpose of this study is to assess the impact of home-based utilization of the PNR program on cancer survivors with CIPN and caregivers applying the ...

4. withpower.com withpower.com/trial/phase-malignant-solid-neoplasms-4-2025-5ae65

Mobile Health App for Peripheral Neuropathy - Cancer Trial Overview The study tests if a mobile health application teaching oncology-informed massage can reduce CIPN symptoms in cancer survivors. It compares this ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1462388925002248

Effectiveness and determinants of a Digital Health ... The Health Belief Model-based digital intervention demonstrated both immediate and sustained positive effects on clinical outcomes, including ...

6. ctv.veeva.com ctv.veeva.com/study/evaluating-a-mobile-health-application-intervention-for-caregiver-instruction-in-manual-therapy-for

Evaluating a Mobile Health Application Intervention for ... An mobile health application (app) for caregivers can teach care for CIPN using safe oncology-informed massage techniques at home.