Clinical trial NCT05556447: Internet-delivered Management of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Official title: Internet-delivered Management of Chemotherapy-Induced Peripheral Neuropathy (CIPN): Outcomes and Exploration of Mechanisms
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: CIPN - Chemotherapy-Induced Peripheral Neuropathy
Keywords: paresthesia
dysesthesia
allodynia
hyperalgesia
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: HonorHealth Research Institute
First posted: 2022-09-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: pilot trial enrolling 26 cancer survivors with chronic chemotherapy-induced peripheral neuropathy (CIPN) who will undergo the painTRAINER intervention
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

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.

Primary outcomes:
measure: Adherence Rate
timeFrame: Week 12
measure: Retention Rate
timeFrame: Week 12
measure: Acceptability of the Intervention
timeFrame: Week12
measure: Pain Interference Score
timeFrame: baseline
measure: Pain Interference Score
timeFrame: Week 12
measure: Pain Interference Score
timeFrame: Week 24
measure: Pain Interference Score
timeFrame: Week 36
Secondary outcomes:
measure: Change in Objective physical function Scores - Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: baseline, 12 weeks, 24 weeks, and 36 weeks
measure: Change in Objective physical function Scores - PROMIS Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale
timeFrame: baseline, 12 weeks, 24 weeks, and 36 weeks
measure: Change in Medication and substance amount use
timeFrame: baseline, 12 weeks, 24 weeks, and 36 weeks
measure: Change in Psychological distress Scores - PROMIS Cognitive Function scale
timeFrame: baseline, 12 weeks, 24 weeks, and 36 weeks
measure: Change in Psychological distress Scores - General Anxiety Disorder scale (GAD 7)
timeFrame: baseline, 12 weeks, 24 weeks, and 36 weeks
measure: Change in Psychological distress Scores - Patient Health Questionnaire (PHQ 8)
timeFrame: baseline, 12 weeks, 24 weeks, and 36 weeks
measure: Coping
timeFrame: baseline, 12 weeks, 24 weeks, and 36 weeks
measure: Spirituality
timeFrame: baseline, 12 weeks, 24 weeks, and 36 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Donald B Penzien, PhD
role: PRINCIPAL_INVESTIGATOR
References: