RECRUITING

The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions

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

The purpose of this single-blind, randomized, controlled study is to assess the efficacy of "informative text messages" vs "traditional handouts" provided to lumbar spine surgery patients post-operatively.

Official Title

The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions

Quick Facts

Study Start:2023-09-07
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04140344

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Primary lumbar fusion 1-4 levels
  2. 2. 18 years or older
  3. 3. Degenerative spine diagnosis
  4. 4. Answers YES to all the following screening questions:
  5. * Do you own a mobile phone that is capable of sending and receiving text messages?
  6. * Do you know how to text and feel comfortable texting?
  7. * Are you a regular (at least once a day) text-message user?
  8. * Are you agreeable to regular contact?
  1. 1. Prior lumbar fusions
  2. 2. Tumors/infection/trauma
  3. 3. Prisoners or institutionalized patients
  4. 4. Non-English speaking patients
  5. 5. Patients who smokes or with uncontrolled diabetes
  6. 6. Participants will be removed from study if discharged to a rehabilitation center or discharged beyond 7 days post-operatively (we are expecting \~15% of patients to be discharged to a rehabilitation center or discharged beyond 7 days post-operatively)

Contacts and Locations

Study Contact

Claudia E Pamanes, MPH
CONTACT
(919) 668-0897
claudia.pamanes@duke.edu

Principal Investigator

Oren N Gottfried, MD FAANS
PRINCIPAL_INVESTIGATOR
Duke Neurosurgery

Study Locations (Sites)

Duke Neurosurgery and Duke Orthopedics
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: Duke University

  • Oren N Gottfried, MD FAANS, PRINCIPAL_INVESTIGATOR, Duke Neurosurgery

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 Date2023-09-07
Study Completion Date2026-10

Study Record Updates

Study Start Date2023-09-07
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

  • Lumbar Fusion
  • Text Message

Additional Relevant MeSH Terms

  • Lumbar Spine Degeneration
  • Lumbar Spine Instability
  • Lumbar Spondylosis