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

CIPN - Chemotherapy-Induced Peripheral Neuropathy Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• CIPN - Chemotherapy-Induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

• NCT number: NCT05556447
• Study type: Interventional
• Source: Wake Forest University Health Sciences
• Contact: Donald B Penzien, PhD
• Phone: 601-454-5573
• Email: penzien@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2024
• Completion date: March 2025