COMPLETED

RECOVER-ENERGIZE Platform Protocol

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 is a platform protocol designed to be flexible so that it is suitable for a range of interventions and settings within diverse health care systems and community settings with incorporation into clinical COVID-19 management programs and treatment plans if results achieve key study outcomes. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating interventions to address and improve exercise intolerance and post-exertional malaise (PEM) as manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). The focus of this protocol is to assess interventions that can improve exercise capacity, daily activities tolerance, and quality of life in patients with PASC.

Official Title

RECOVER-ENERGIZE: A Platform Protocol for Evaluation of Interventions for Exercise Intolerance in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

Quick Facts

Study Start:2024-07-17
Study Completion:2025-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06404047

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. ≥ 18 years of age at the time of enrollment
  2. 2. Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by the Pan American Health Organization\*
  3. * Suspected\* or probable SARS-CoV-2 infection will only be allowed if it occurred before May 1, 2021, and will be limited to no more than 10% of the study population. Otherwise, confirmed cases are required.
  4. 3. Self-reported limitation to physical activity due to the presence of symptoms such as fatigue, shortness of breath, and/or PEM following a SARS-CoV-2 infection, that has persisted for at least 12 weeks and is present at the time of consent.
  5. 4. Willing, able, and agree to provide informed consent, complete questionnaires and outcome assessments, and participate in the study, including assigned intervention or control and study visits whether remote, hybrid, or in-person.
  1. 1. Known active acute SARS-CoV-2 infection ≤ 4 weeks prior to the consent.
  2. 2. Known prior diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), not related to SARS-CoV-2 infection.
  3. 3. Current or recent use (within the last 14 days) of a formal program utilizing one or more of the current study intervention(s) or similar intervention(s) to treat the underlying condition, unless a washout period is permitted per Appendices.
  4. 4. Participation in another interventional clinical trial.
  5. 5. Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study.

Contacts and Locations

Principal Investigator

Gary M Felker, MD
STUDY_CHAIR
Duke Clinical Research Institute
Barry Make, MD
STUDY_CHAIR
National Jewish Health
Lucinda Bateman, MD
STUDY_CHAIR
Bateman Horne Center
Janna Friedly, MD, MPH
STUDY_CHAIR
University of Washington

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35205
United States
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
United States
Banner University Medical Center Tucson
Tucson, Arizona, 85719
United States
Stanford University
Stanford, California, 94035
United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, 90509
United States
University of Colorado
Aurora, Colorado, 80045
United States
Yale - New Haven Hospital
New Haven, Connecticut, 06520-8017
United States
University of Florida College of Medicine Jacksonville
Jacksonville, Florida, 32209
United States
Innovation Clinical Trials Inc.
Miami, Florida, 33144
United States
Valencia Medical and Research Center
Miami, Florida, 33165
United States
Grady Memorial Hospital (Emory)
Atlanta, Georgia, 30303
United States
Emory Hope Clinic
Decatur, Georgia, 30030
United States
University of Illinois at Chicago
Chicago, Illinois, 60608
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
North Shore University HealthSystem/Evanston Hospital
Evanston, Illinois, 60201
United States
Saint Francis Medical Center
Peoria, Illinois, 61637
United States
Cedar Valley Clinical Research
Waterloo, Iowa, 50701
United States
Kansas University Medical Center
Kansas City, Kansas, 66160
United States
University of Kentucky
Lexington, Kentucky, 40536
United States
Maine Health Institute of Research
Scarborough, Maine, 04074
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Beth Israel Deaconess Med. Ctr.
Boston, Massachusetts, 02215
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Washington University School of Medicine
St Louis, Missouri, 63110
United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87102
United States
NYU Langone Health/Brooklyn Hospital
Brooklyn, New York, 11220
United States
University of North Carolina Hospital
Chapel Hill, North Carolina, 27514
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Oregon Health and Science University
Portland, Oregon, 97239-3098
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Avera McKennan Hospital & University Health Center
Sioux Falls, South Dakota, 57108
United States
Southwest Family Medicine Associates
Dallas, Texas, 75235
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States
University of Utah
Salt Lake City, Utah, 84132
United States
Vermont Lung Center, University of Vermont
Colchester, Vermont, 05446
United States
University Physicians and Surgeons, Inc dba Marshall Health
Huntington, West Virginia, 25701
United States
West Virginia Clinical and Translational Science Institute
Morgantown, West Virginia, 26506
United States

Collaborators and Investigators

Sponsor: Duke University

  • Gary M Felker, MD, STUDY_CHAIR, Duke Clinical Research Institute
  • Barry Make, MD, STUDY_CHAIR, National Jewish Health
  • Lucinda Bateman, MD, STUDY_CHAIR, Bateman Horne Center
  • Janna Friedly, MD, MPH, STUDY_CHAIR, University of Washington

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 Date2024-07-17
Study Completion Date2025-10-30

Study Record Updates

Study Start Date2024-07-17
Study Completion Date2025-10-30

Terms related to this study

Keywords Provided by Researchers

  • PASC
  • Exercise
  • PEM (post exertional malaise)

Additional Relevant MeSH Terms

  • Long COVID
  • Long Covid19
  • Long Covid-19