RECRUITING

STAT: Standard Therapy Plus Active Therapy

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 objective of the study is to assess the efficacy of STAT, an activity-based therapy protocol compared to standard therapy (ST) to improve functional outcome and reduce disability in patients recovering from burn injury. This randomized multi-center trial is designed with two parallel treatment groups: STAT and ST. Efficacy of the STAT protocol will be determined through comparison to the ST only group. It will be conducted at seven burn centers.

Official Title

STAT: Standard Therapy Plus Active Therapy to Improve Mobility, Long-Term Activity, and Quality of Life for Severely Burn Injured Patients After Skin Graft Surgery

Quick Facts

Study Start:2020-10-26
Study Completion:2025-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04368117

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 to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 18 to 65 years old
  2. 2. Total TBSA of 15% or greater with at least 10% TBSA of third-degree burn
  3. 3. Potential need for a skin graft procedure determined by the local burn surgeon
  4. 4. Survivable burn injury determined by the admitting local burn surgeon on admission
  1. 1. Non-survivable burn injury determined by the admitting local burn surgeon on admission
  2. 2. History of chronic renal failure requiring dialysis prior to injury
  3. 3. History of developmental delay or congenital cognitive disorders
  4. 4. Prior history of connective tissue disorders or autoimmune disease
  5. 5. Anoxic or traumatic brain injury
  6. 6. Prior history of cerebrovascular accident with residual mobility impairment
  7. 7. Neurologic injury or disease-causing mobility impairment
  8. 8. Prior history of leg amputation
  9. 9. Non-viable leg requiring amputation on admission
  10. 10. Anticipated inability to return for follow up testing after discharge
  11. 11. History of a New York Heart Association (NYHA) class IV congestive heart failure

Contacts and Locations

Study Contact

Katrina Falwell, BSN RN
CONTACT
916-453-2134
kafalwell@ucdavis.edu

Principal Investigator

Soman Sen, MD
PRINCIPAL_INVESTIGATOR
UC Davis

Study Locations (Sites)

ValleyWise Health
Phoenix, Arizona, 85008
United States
University of California Davis Medical Center-Regional Burn Center
Sacramento, California, 95817
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Health and Hospital Corporation dba Eskenazi Health
Indianapolis, Indiana, 46202
United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States
United States Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234
United States

Collaborators and Investigators

Sponsor: American Burn Association

  • Soman Sen, MD, PRINCIPAL_INVESTIGATOR, UC Davis

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 Date2020-10-26
Study Completion Date2025-09-30

Study Record Updates

Study Start Date2020-10-26
Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

  • Physical impairment

Additional Relevant MeSH Terms

  • Burn Injury
  • Physical Injury
  • Thermal Burn