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

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Sep 22, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how an online program can help cancer survivors manage the pain caused by chemotherapy, known as chemotherapy-induced peripheral neuropathy (CIPN). For 8 weeks, participants will use internet-delivered resources to learn pain coping strategies and share their experiences. The trial aims to see if this program is easy to use and if it can help reduce pain and improve daily functioning.

To join the study, participants must be adults aged 18 and older who have been diagnosed with invasive cancer and have experienced CIPN symptoms after receiving certain types of chemotherapy. They should have completed their cancer treatment at least 2 years ago and currently be stable in their health. Participants will need to have a reliable internet connection to use the program. Throughout the study, they can expect to engage in various online activities and provide feedback about their pain and overall well-being. This trial hopes to find better ways to support those dealing with the lingering effects of cancer treatment.

Gender

ALL

Eligibility criteria

• 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.