RECRUITING

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

Conditions

CIPN - Chemotherapy-Induced Peripheral Neuropathy paresthesia dysesthesia allodynia hyperalgesia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-19

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05556447

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Donald B Penzien, PhD

CONTACT

601-454-5573

penzien@gmail.com

Megan B Irby, PhD

CONTACT

336-757-2610

irbyM@wfu.edu

Principal Investigator

Donald B Penzien, PhD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Study Locations (Sites)

HonorHealth

Scottsdale, Arizona, 85251

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Donald B Penzien, PhD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2024-02-19

Study Completion Date2025-06

Study Record Updates

Study Start Date2024-02-19

Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

paresthesia
dysesthesia
allodynia
hyperalgesia

Additional Relevant MeSH Terms

CIPN - Chemotherapy-Induced Peripheral Neuropathy