Ignite Creation Date:
2024-05-06 @ 6:08 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05556447
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2022-09-22
Brief Title:
Internet-delivered Management of Chemotherapy-Induced Peripheral Neuropathy CIPN
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Internet-delivered Management of Chemotherapy-Induced Peripheral Neuropathy CIPN Outcomes and Exploration of Mechanisms
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a small pilot trial n26 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 eg drug mechanism based to individual pain phenotyping that characterizes CIPN patients based on the reaction of the nervous system eg 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 patientsproviders Better understanding of CIPNs 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 lifefunctioning 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None