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

NCT05556447 | Withdrawn

• 2 other identifiers: IRB0008649540010561
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

CIPN - Chemotherapy-Induced Peripheral Neuropathy

Keywords

paresthesia; dysesthesia; allodynia; hyperalgesia

Outcome Measures

Primary Outcomes (7)

• Adherence Rate

  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

  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

  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

  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

  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

  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

  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 Outcomes (8)

• Change in Objective physical function Scores - Patient-Reported Outcomes Measurement Information System (PROMIS)

  baseline, 12 weeks, 24 weeks, and 36 weeks

• Change in Objective physical function Scores - PROMIS Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale

  baseline, 12 weeks, 24 weeks, and 36 weeks

• Change in Medication and substance amount use

  baseline, 12 weeks, 24 weeks, and 36 weeks

• Change in Psychological distress Scores - PROMIS Cognitive Function scale

  baseline, 12 weeks, 24 weeks, and 36 weeks

• Change in Psychological distress Scores - General Anxiety Disorder scale (GAD 7)

  baseline, 12 weeks, 24 weeks, and 36 weeks

Study Arms (1)

Internet delivered pain coping

EXPERIMENTAL

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

Interventions

Internet delivered pain coping skills training BEHAVIORAL

Participants in the intervention group will complete 8 weeks of pain coping skills training delivered online

Also known as: PCST

Internet delivered pain coping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• HonorHealth Research Institute: collaborator

MeSH Terms

Conditions

Paresthesia; Hyperalgesia

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Donald B Penzien, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pilot trial enrolling 26 cancer survivors with chronic chemotherapy-induced peripheral neuropathy (CIPN) who will undergo the painTRAINER intervention

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 27, 2022
• Study Start: February 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 6, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share