ACTIVE_NOT_RECRUITING

Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This Registry study will prospectively evaluate the differences in treatment outcomes in terms of pain intensity, pain interference, concomitant medication use, health-related quality of life, opioid adverse effects, and healthcare utilization between targeted drug delivery and conservative medication management only groups.

Official Title

Intrathecal Targeted Drug Delivery for Cancer Associated Pain

Quick Facts

Study Start:2022-12-06
Study Completion:2026-01-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05674240

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age of 21 and older
  2. * Uncontrolled cancer-associated pain (pain score of \>5 on NRS) despite oral use of 60 mg/d morphine equivalent a week prior to screening
  3. * Adverse side effects from long term opioid use defined as limiting or severely affecting patient's day to day function
  4. * Life expectancy of \> 3 months
  1. * Active infections
  2. * Controlled pain without adverse side effects that are limiting day to day function
  3. * Mechanical barriers
  4. * Obstruction of Cerebrospinal Fluid (CSF)

Contacts and Locations

Principal Investigator

Littlefield Lauren, MD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Advocate Aurora Health
Oshkosh, Wisconsin, 54904
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Littlefield Lauren, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-06
Study Completion Date2026-01-20

Study Record Updates

Study Start Date2022-12-06
Study Completion Date2026-01-20

Terms related to this study

Keywords Provided by Researchers

  • targeted drug delivery
  • cancer pain
  • conservative pain management
  • neuromodulation
  • opioid
  • healthcare-utilization
  • quality of life

Additional Relevant MeSH Terms

  • Cancer Pain
  • Chronic Pain
  • Cancer Associated Pain
  • Neuropathic Pain