Internet-delivered Management of Chemotherapy-Induced Peripheral Neuropathy (CIPN)

April 2, 2025 updated by: Wake Forest University Health Sciences

Internet-delivered Management of Chemotherapy-Induced Peripheral Neuropathy (CIPN): Outcomes and Exploration of Mechanisms

This is a small pilot trial (n=26) among cancer survivors with CIPN who will utilize an internet-delivered pain coping program for 8 weeks in order to assess program feasibility and preliminary understanding of how participation in the program may influence pain interference. Also proposed is a secondary focus on subjective and objective function, medication use, psychological distress, and coping.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Chemotherapy-induced peripheral neuropathy (CIPN) is a sensory polyneuropathy occurring in 50-75% of patients receiving neurotoxic chemotherapy that presents with varying degrees of paresthesia, dysesthesia, allodynia, hyperalgesia, and pain. For 30% of survivors, CIPN remains for a lifetime, often accompanied by morbidity, increased healthcare utilization, impaired functional and psychological status, strained relationships, and reduced quality of life. CIPN patients often present with multiple patterns of peripheral neuropathy owing to diversity in their causative etiologies, environmental factors, and patient-specific pathophysiology. Recent studies call for a shift in focus from solely etiologic characterization (e.g. drug mechanism based) to individual pain phenotyping that characterizes CIPN patients based on the reaction of the nervous system (e.g. pain processing). Given its high prevalence, complex presentation, absence of effective prevention, and few established therapies for addressing long-term symptoms, CIPN poses a major burden to patients/providers. Better understanding of CIPN's underlying biological and psychosocial mechanisms paired with enhanced access to effective interventions may lead to improved CIPN management. Cognitive behavioral pain coping skills training (PCST) has shown effectiveness for reducing pain-related suffering among patients with cancer pain as well as those experiencing various neuropathic symptoms-they target specific psychological processes known to contribute to pain, distress, and disability. Despite established effectiveness, in-person PCST interventions often are underused in clinical care due to barriers such as high resource costs, shortage of trained therapists, and travel requirements. There remains a need for evidence-based behavioral pain interventions for CIPN delivered with innovative methods to overcome treatment access barriers, reduce pain interference, and enhance quality of life/functioning. We developed an 8-week internet-delivered PCST program using an expert systems approach designed to retain essential features of in-person PCST that does not require therapist involvement-a concept increasingly important for providing socially-distant care amid the corona virus disease (COVID-19) pandemic. The published small trials investigating PCST for CIPN demonstrates promise of this approach for reducing the CIPN burden and justifies larger-scale testing of internet-based PCST for CIPN.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Megan B Irby, PhD
  • Phone Number: 336-757-2610
  • Email: irbyM@wfu.edu

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Recruiting
        • HonorHealth
        • Principal Investigator:
          • Glenn J Lesser, MD
        • Sub-Investigator:
          • Megan B Irby, PhD
        • Sub-Investigator:
          • Donald B Penzien, PhD
        • Contact:
          • Donald B Penzien, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Must have a documented diagnosis of invasive cancer (of any type) requiring neurotoxic chemotherapy (alone, in combination, or in conjunction with surgery or radiation). Individuals with a cancer history of only superficial skin cancers or in situ malignancy are not eligible.
  • Must have clinical symptoms of Grade 2 or Grade 3 peripheral neuropathy (National Cancer Institute Common Terminology Criteria for Adverse Events), AND clinically documented chemotherapy-induced peripheral neuropathy (CIPN) following treatment with any single or combined neurotoxic chemotherapy (i.e., platinums, vinca alkaloids, taxanes, or proteasome inhibitors).
  • Must have been ≥24 months since the time in which neurotoxic chemotherapy was first initiated (i.e., time since the first administration of neurotoxic chemotherapy), and either no evidence of residual disease or with stable disease, as established by imaging/clinical exam/laboratory testing.
  • Must have completed all planned anticancer therapy (with the exception of maintenance therapy when appropriate). Maintenance therapy includes planned chronic immunotherapy, hormonal therapy, targeted therapy to prevent recurrence of disease rather than to treat active disease. Individuals on maintenance therapy and actively receiving chemotherapy drugs are not eligible. Time frame applies to most recent completion of chemotherapy treatment if participant has experienced cancer recurrence(s).
  • Must report a score of ≥ 4 on the single item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity (1a) scale.
  • Must report experiencing symptoms of pain, physical suffering, or discomfort, of any intensity, on at least "Most Days" of the week on the Graded Chronic Pain Scale Revised (Abbreviated).
  • Must be on a stable medication regimen (i.e., no changes to prescribed analgesic or neuropathic pain medication regimens) over a period of at least 30 days prior to enrollment, and no upward dose titrations during the intervention period, including: opioid analgesics (i.e., hydrocodone, oxycodone, tramadol, etc), duloxetine (i.e., Cymbalta), pregabalin (e.g., Lyrica), gabapentin (e.g., Neurontin, Gralise). Changes to prescriptions during the study should only occur if advised by a participant's doctor. Unexpected adjustments to prescriptions due unforeseen clinical need are allowable at any time.
  • Must be expected to be able to complete all study activities according to the treating/referring clinician.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Age 18 or older at the time of study entry.
  • Must be able to speak, read, and understand English.

Exclusion Criteria:

  • Has a disability or condition that precludes completion of study activities (e.g., severe vision or hearing impairment, diagnosis of dementia or clinical evidence of severe cognitive impairment; diagnosis or clinical evidence of severe psychiatric disorder; diagnosed drug or alcohol abuse disorder), as per patient report or documented in the medical record.
  • Reports only preexisting pain conditions deemed unrelated to CIPN (e.g., migraine headache, arthritis, back disorders, bursitis/tendonitis, injuries, fibromyalgia).
  • Has symptoms of preexisting neuropathy prior to treatment with neurotoxic chemotherapy (i.e., self-reported or documented history of unresolved or pre- existing peripheral neuropathy due to diabetes, HIV, or other conditions known to be unrelated to chemotherapy treatment).
  • Has a known or suspected diagnosable substance use disorder (according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria) or is actively receiving treatment for one, per patient report or documented in the medical record.
  • Currently being prescribed buprenorphine or suboxone.
  • Suspected or proven progressive cancer by clinical history, exam or imaging evaluation.
  • Enrolled in hospice care or end-of-life palliative care.
  • No reliable access to Internet, wi-fi, or compatible device, and declines the Tablet Lending Program.
  • Does not have a working email address.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Internet delivered pain coping
8 week online pain coping skills training program with weekly, 45-minute modules guided by an automated coach
Behavioral: Internet delivered pain coping skills training
Participants in the intervention group will complete 8 weeks of pain coping skills training delivered online
Other Names:
  • PCST

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adherence Rate
Time Frame: Week 12
Participant adherence in the pilot trial will be measured individually based on the number of modules completed, of the 8 possible modules, during the 12 week intervention period. Participants who complete 6 of the 8 modules will be considered "completers" of the program, though the percent adherence to the program would be 75%.
Week 12
Retention Rate
Time Frame: Week 12
Participant retention in the pilot trial will be based on the percentage of all participants that are retained in the trial overtime. If 100% of participants complete 100% of the modules, this would equate to a 100% retention rate.
Week 12
Acceptability of the Intervention
Time Frame: Week12
Acceptability will be assessed based on two indicators: the ability to recruit the desired number of participants into the trial during the specified recruitment period (26 total participants) and based on assessments of participant satisfaction with the program. Participant satisfaction will be assessed via satisfaction surveys developed specifically for the online pain coping skills training intervention, with questions scored on a likert scale ranging from "not at all satisfied" to "very satisfied" for each unique aspect of the program.
Week12
Pain Interference Score
Time Frame: baseline
Preliminary efficacy of the program will be assessed based on how well the program results in improvements in participant's levels of pain interference, which will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale and the Brief Pain Inventory Pain Interference scale.
baseline
Pain Interference Score
Time Frame: Week 12
Preliminary efficacy of the program will be assessed based on how well the program results in improvements in participant's levels of pain interference, which will be measured via combined composite scores developed from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale and the Brief Pain Inventory Pain Interference scale.
Week 12
Pain Interference Score
Time Frame: Week 24
Preliminary efficacy of the program will be assessed based on how well the program results in improvements in participant's levels of pain interference, which will be measured via combined composite scores developed from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale and the Brief Pain Inventory Pain Interference scale.
Week 24
Pain Interference Score
Time Frame: Week 36
Preliminary efficacy of the program will be assessed based on how well the program results in improvements in participant's levels of pain interference, which will be measured via combined composite scores developed from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale and the Brief Pain Inventory Pain Interference scale.
Week 36

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Objective physical function Scores - Patient-Reported Outcomes Measurement Information System (PROMIS)
Time Frame: baseline, 12 weeks, 24 weeks, and 36 weeks
Participant reports of their physical functioning will be assessed using physical activity questionnaires; the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 6b - Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.
baseline, 12 weeks, 24 weeks, and 36 weeks
Change in Objective physical function Scores - PROMIS Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale
Time Frame: baseline, 12 weeks, 24 weeks, and 36 weeks
Participant reports of their physical functioning will be assessed using physical activity questionnaires; the PROMIS Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale - The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued)
baseline, 12 weeks, 24 weeks, and 36 weeks
Change in Medication and substance amount use
Time Frame: baseline, 12 weeks, 24 weeks, and 36 weeks
Medication and substance use will be monitored with diaries completed at multiple timepoints during the study, and using the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS). The TAPS assesses substance use behaviors over the last 12 months.
baseline, 12 weeks, 24 weeks, and 36 weeks
Change in Psychological distress Scores - PROMIS Cognitive Function scale
Time Frame: baseline, 12 weeks, 24 weeks, and 36 weeks
Psychological distress will be assessed via the PROMIS Cognitive Function scale, a 4-item questionnaire that asks participants to report on how often they have experienced certain thoughts and cognitive processes over the last 7 days, scored on a likert scale from "never" to "very often".
baseline, 12 weeks, 24 weeks, and 36 weeks
Change in Psychological distress Scores - General Anxiety Disorder scale (GAD 7)
Time Frame: baseline, 12 weeks, 24 weeks, and 36 weeks
Psychological distress will be assessed via the General Anxiety Disorder scale (GAD 7) - GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety. 5-9: mild anxiety. 10-14: moderate anxiety. 15-21: severe anxiety.
baseline, 12 weeks, 24 weeks, and 36 weeks
Change in Psychological distress Scores - Patient Health Questionnaire (PHQ 8)
Time Frame: baseline, 12 weeks, 24 weeks, and 36 weeks
Psychological distress will be assessed via the Patient Health Questionnaire (PHQ 8) - Total score is determined by adding together the scores of each of the four items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12) -Total score ≥3 for first 2 questions suggests anxiety -Total score ≥3 for last 2 questions suggests depression.
baseline, 12 weeks, 24 weeks, and 36 weeks
Coping
Time Frame: baseline, 12 weeks, 24 weeks, and 36 weeks
Coping will be assessed via questionnaire designed specifically for the internet-based pain coping skills program featured in the intervention. Questions pertain to how well participants feel that have developed adaptive coping strategies related to their pain coping processes, as well as how often they incorporate new coping skills into daily life.
baseline, 12 weeks, 24 weeks, and 36 weeks
Spirituality
Time Frame: baseline, 12 weeks, 24 weeks, and 36 weeks
Spirituality will be assessed using the 38-item Brief Multidimensional Measure of Religiousness and Spirituality, which assesses spirituality across 11 domains, including: daily spiritual experiences; values and beliefs; forgiveness; private religious practices; religious and spiritual coping; religious support; religious and spiritual history; commitment; organizational religiousness, and overall self ranking.
baseline, 12 weeks, 24 weeks, and 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
HonorHealth Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Donald B Penzien, PhD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00086495
  • 40010561 (Other Identifier: National Cancer Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings