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

Trial Summary

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 data supports the effectiveness of this treatment for chemotherapy-induced peripheral neuropathy?

Research on similar web-based interventions for chemotherapy-induced neuropathy shows that they can help reduce the impact of symptoms on daily activities, with one study reporting a moderate effect in decreasing interference with activities. This suggests that mobile health apps could also be effective in managing symptoms. ^{1 2 3 4 5}

Is the Mobile Health App for Peripheral Neuropathy safe for humans?

The studies on similar web-based programs for managing chemotherapy-induced peripheral neuropathy show that they are generally safe, with high usability and acceptability among patients. No specific safety concerns were reported in these studies. ^{1 2 4 5 6}

How is the Mobile Health App for Peripheral Neuropathy treatment different from other treatments for this condition?

The Mobile Health App for Peripheral Neuropathy is unique because it uses a digital platform to guide caregivers in providing manual therapy for chemotherapy-induced peripheral neuropathy, offering a novel approach that combines technology with hands-on care, unlike traditional treatments that may not involve caregiver participation or digital tools. ^{1 2 3 7 8}

What is the purpose of this trial?

This clinical trial assesses the impact of a family caregiver-delivered massage technique for use in cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a common cancer treatment side effect that impairs quality of life and daily functioning. Aside from the relatively transient effects of chemotherapy treatment (e.g., nausea, diarrhea, vomiting, infections, fatigue, hair loss), chemotherapy can damage nervous system structures leading to long-term CIPN effects including numbness in hands or feet, "pins and needles" or sudden stabbing pains, difficulty buttoning clothing or picking up objects, loss of balance and risk of falling, difficulty driving (steering wheel, foot pedals), and increased sensitivity to heat or cold. Caregivers who lack effective strategies of supportive care are at risk of feeling helpless, overwhelmed or frustrated watching their loved one suffer. Oncology massage (OM) teaches oncology-informed modifications, adaptations and safety precautions for a cancer survivor's specific condition, treatment history and side effects. An mobile health application (app) for caregivers can teach care for CIPN using safe oncology-informed massage techniques at home. Using the Peripheral Neuropathy Relief (PNR) program in the form of relaxation may help for stress reduction, reduced CIPN symptoms, and/or an increased sense of connection with patients and their family caregiver.

Research Team

William Collinge, PhD, MPH

Principal Investigator

Collinge and Associates, Inc.

Cindy Tofthagen, PhD, RN

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Usability and Acceptability of a Web-Based Program for Chemotherapy-Induced Peripheral Neuropathy. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Pilot Testing a Web-Based System for the Assessment and Management of Chemotherapy-Induced Peripheral Neuropathy. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Nursing knowledge, practice patterns, and learning preferences regarding chemotherapy-induced peripheral neuropathy. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

In Search of a Gold Standard Patient-Reported Outcome Measure for Use in Chemotherapy- Induced Peripheral Neuropathy Clinical Trials. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Co-designing a behavioural intervention for reducing the impact of chemotherapy-induced peripheral neuropathy symptoms: An evidence- and theory-driven approach. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of chemotherapy-induced peripheral neuropathy on treatment delivery in nonmetastatic breast cancer. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Design and evaluation of a portable smart-phone based peripheral neuropathy test platform. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Role of Kinematics Assessment and Multimodal Sensorimotor Training for Motion Deficits in Breast Cancer Chemotherapy-Induced Polyneuropathy: A Perspective on Virtual Reality Avatars. [2020]