Remote Monitoring and Management for Chemotherapy-Induced Peripheral Neuropathy

(REMOTE-CIPN Trial)

Recruiting at 2 trial locations

Overseen By Mary Healey

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Vermont

Must not be taking: Neurotoxic chemotherapy

Disqualifiers: Neurological problems, Diabetes, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

422 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective randomized trial designed to investigate a new care model for patients who suffer from nerve damage from chemotherapy called chemotherapy induced peripheral neuropathy (CIPN). All participants in the study will report their CIPN symptoms daily using a website, app or phone for 12 weeks. In one group the data will be collected and participants will be encouraged to reach out to their treating doctors for uncontrolled symptoms. These participants' doctors can prescribe any treatment they feel is appropriate. In the second group, if the symptoms meet the criteria for eligibility they will receive a phone call from a nurse practitioner either the same day or next day, depending on the time symptoms were logged. That nurse practitioner will determine the correct CIPN treatment using an algorithm and prescribe it. The study will track the severity of symptoms over time as well as looking at the impact on treatments for CIPN (medications and referrals).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it does mention that participants' doctors can prescribe any treatment they feel is appropriate, which suggests you may continue your current medications unless advised otherwise by your doctor.

Is the treatment for chemotherapy-induced peripheral neuropathy safe for humans?

The research articles provided do not contain specific safety data for the treatment options mentioned, such as Symptom Care at Home with NP follow up or Cymbalta, in the context of chemotherapy-induced peripheral neuropathy. ^{1 2 3 4 5}

How does the remote monitoring and management treatment for chemotherapy-induced peripheral neuropathy differ from other treatments?

This treatment is unique because it uses a web-based program to help patients self-manage their symptoms, which is not commonly available for chemotherapy-induced peripheral neuropathy. It focuses on patient activation and self-monitoring, allowing patients to be more involved in their care and potentially reducing the impact of symptoms on daily activities. ^{6 7 8 9 10}

Research Team

Noah Kolb, MD

Principal Investigator

University of Vermont

Eligibility Criteria

This trial is for adults who finished certain cancer chemotherapies within the last 540 days and developed nerve damage (CIPN) from it. They must speak/read English to use the study tools and not be pregnant or planning another neurotoxic chemotherapy soon. People with other neurological issues or intractable pain, on birth control they're unwilling to change, or in another CIPN/pain study can't join.

Inclusion Criteria

Your diagnosis of chemotherapy-induced peripheral neuropathy (CIPN) needs to be confirmed by a specialist who will review your medical records and may also talk to you or examine you.

I developed nerve pain or tingling after my recent chemotherapy.

I finished my cancer chemotherapy within the last 540 days.

Exclusion Criteria

I have severe cancer pain that needs treatment from a pain clinic.

I do not have nerve problems from other conditions that could affect nerve damage assessments.

I agree to use effective birth control during the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Remote symptom logging

Run-in

Participants log neuropathy symptoms daily for a one week run-in period using remote symptom monitoring technology

1 week

Remote symptom logging

Treatment

Participants report CIPN symptoms daily for 12 weeks. Usual Care group receives standard care, while SCH-NP group receives nurse practitioner follow-up for concerning symptoms

12 weeks

3 visits (in-person at baseline, 6 weeks, and 12 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Symptom Care at Home with NP follow up

Trial Overview The trial tests a new care model for managing chemotherapy-induced nerve damage symptoms. Participants report their symptoms daily for 12 weeks using digital tools. One group's doctors manage their care as usual, while the other gets prompt NP calls based on an algorithm to prescribe treatment.

Participant Groups

Group I: SCH with NP follow-up (SCH-NP) Experimental Treatment 1 Intervention

Participants will report daily symptom as above. The SCH system will notify the study NP for any of the following symptoms measured by the NTSS6: aching, allodynia, burning, lancinating, numbness, and prickling that are concerning. Participants will receive a NP call back either the same day or the next day, depending on the time they reported their symptoms. The NP will follow a standardized script to elicit details about the CIPN symptoms and recommend and prescribe CIPN treatment per the treatment algorithm.

Group II: Usual Care (UC) Active Control 1 Intervention

The UC group (control) models the current standard of care model. The NTSS-6 will be completed daily by participants using the SCH system. The results will not be reported to their oncology team. Participants will be counseled at study entry to contact their treating care team to manage CIPN symptoms. They will also receive a reminder to do so at the end of each reporting session. UC participants will attend all regular visits with these providers and can receive any type of treatment for their CIPN symptoms. There are no limitations on the therapies that can be prescribed, or the means by which the clinical team communicates with the participant. Treating physicians will be provided with links to the current ASCP and NCCN guidelines but will not be provided with the algorithm as this group is meant to reflect current standard medical practice.

Who Is Running the Clinical Trial?

University of Vermont

Lead Sponsor

Trials

283

Recruited

3,747,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Virginia Commonwealth University

Collaborator

Trials

732

Recruited

22,900,000+

Findings from Research

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 296 long-term breast cancer survivors who received taxane-based chemotherapy, 58.4% reported symptoms of chemotherapy-induced peripheral neuropathy (CIPN), with obesity identified as a significant risk factor for developing these symptoms.

Survivors with CIPN experienced higher levels of psychological distress, including anxiety and depression, and had increased rates of falls, highlighting the need for targeted interventions that address both CIPN and associated mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term chemotherapy-induced peripheral neuropathy among breast cancer survivors: prevalence, risk factors, and fall risk. Bao, T., Basal, C., Seluzicki, C., et al.[2022]

In a study of 126 women treated with taxane-based chemotherapy for breast cancer, 73% reported experiencing chemotherapy-induced peripheral neuropathy (CIPN), which significantly affected their quality of life and physical functioning.

CIPN severity was notably higher in Black or African American women, indicating a need for targeted screening and intervention strategies to address this disparity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevalence and pattern of chemotherapy-induced peripheral neuropathy among women with breast cancer receiving care in a large community oncology practice. Simon, NB., Danso, MA., Alberico, TA., et al.[2022]

The updated ASCO guidelines recommend altering chemotherapy treatment for patients who develop chemotherapy-induced peripheral neuropathy (CIPN), but they lack clear criteria on when and how to make these alterations based on CIPN severity.

This review provides a patient-centric decision framework for clinicians, emphasizing the need to balance the benefits of reducing CIPN severity against the risks of compromising cancer treatment efficacy when considering changes to neurotoxic chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centric decision framework for treatment alterations in patients with Chemotherapy-induced Peripheral Neuropathy (CIPN). Hertz, DL., Childs, DS., Park, SB., et al.[2021]

The Chilean version of the FACT/GOG-Ntx neurotoxicity subscale is a valid and reliable tool for assessing chemotherapy-induced neurotoxicity symptoms in adult cancer survivors, based on a study of 101 participants.

The study found that women reported greater emotional distress and neurotoxicity symptoms compared to men, highlighting the scale's ability to differentiate between sex-based experiences of neurotoxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity Questionnaire for the Latin American Population. Ribeiro, IL., Lorca, LA., Cuevas-Cid, R., et al.[2022]

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]

A self-monitoring intervention for managing chemotherapy-induced peripheral neuropathy (CIPN) was evaluated in a randomized controlled trial with 65 participants over 6 weeks, showing that it significantly improved self-efficacy scores compared to the control group.

While the self-monitoring did not lead to significant differences in CIPN scores or safety behaviors, it effectively maintained and improved the quality of life for participants, indicating its potential as a supportive strategy for patients experiencing CIPN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial quantifying the effectiveness of a self-monitoring intervention in cancer patients with peripheral neuropathy: A quantitative study. Kanda, K., Ishida, K., Kyota, A., et al.[2023]

A survey of 405 cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN) revealed that while many self-care activities were commonly used, such as walking and watching television, these did not correlate with the highest effectiveness ratings for symptom relief.

The most effective self-care activities reported included trigger point injections and tranquilizers, suggesting that some less commonly used methods may be more beneficial and should be evaluated further for their potential in managing CIPN symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occurrence and perceived effectiveness of activities used to decrease chemotherapy-induced peripheral neuropathy symptoms in the feet. Ogle, T., Alexander, K., Yates, P., et al.[2021]

The Carevive® Care Planning System (CPS) significantly improved patient activation scores in assessing and managing chemotherapy-induced peripheral neuropathy (CIPN) among 75 women with breast cancer, indicating its potential effectiveness in enhancing patient involvement in care.

Despite the improvement in activation scores, patients found the CPS to have minimal value since it focused solely on CIPN, which was not severe enough for many to seek additional symptom management information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the Impact of a Web-Based Intervention to Promote Patient Activation in Chemotherapy-Induced Peripheral Neuropathy Assessment and Management. Knoerl, R., Lee, D., Yang, J., et al.[2019]

The ESRA-C intervention, which includes symptom screening and self-care recommendations, helped participants receiving neurotoxic chemotherapy maintain better physical function compared to those who only received electronic assessments, with a significant difference in physical functioning scores (p = 0.011).

Participants in the intervention group also experienced significantly less depression and less severe sensory and motor symptoms of chemotherapy-induced peripheral neuropathy (CIPN) when compared to the control group, particularly among those receiving high doses of neurotoxic chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the efficacy of an electronic symptom assessment and self-care intervention to preserve physical function in individuals receiving neurotoxic chemotherapy. Knoerl, R., Weller, E., Halpenny, B., et al.[2019]

References

1. 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]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term chemotherapy-induced peripheral neuropathy among breast cancer survivors: prevalence, risk factors, and fall risk. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

The prevalence and pattern of chemotherapy-induced peripheral neuropathy among women with breast cancer receiving care in a large community oncology practice. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Patient-centric decision framework for treatment alterations in patients with Chemotherapy-induced Peripheral Neuropathy (CIPN). [2021]

5. Egypt pubmed.ncbi.nlm.nih.gov

Validation of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity Questionnaire for the Latin American Population. [2022]

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

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

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

Randomized clinical trial quantifying the effectiveness of a self-monitoring intervention in cancer patients with peripheral neuropathy: A quantitative study. [2023]

8. Scotland pubmed.ncbi.nlm.nih.gov

Occurrence and perceived effectiveness of activities used to decrease chemotherapy-induced peripheral neuropathy symptoms in the feet. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Examining the Impact of a Web-Based Intervention to Promote Patient Activation in Chemotherapy-Induced Peripheral Neuropathy Assessment and Management. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Exploring the efficacy of an electronic symptom assessment and self-care intervention to preserve physical function in individuals receiving neurotoxic chemotherapy. [2019]