RECRUITING

Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial

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 study is about determining if an aerobic and resistance exercise intervention is feasible in patients diagnosed with acute or chronic GVHD (Graft-Versus-Host Disease) after having an allogeneic stem cell transplant. The names of the study interventions involved in this study are: * Aerobic and resistance exercise (A+R) - Home-based aerobic and resistance exercise program * Attention control (AC) - Home-based stretching program

Official Title

Impact of Exercise on the Complications of Corticosteroids in Patients With Graft-Versus-Host Disease Following Allogeneic Stem Cell Transplantation: the RESTART Trial

Quick Facts

Study Start:2022-04-14
Study Completion:2025-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05236062

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. * Over 18 years old; children under the age of 18 will be excluded due to rarity of disease
  2. * Newly diagnosed with acute or chronic GVHD, starting corticosteroids at a dose of 1 mg/kg or greater for the first time since transplant
  3. * Received allogeneic stem cell transplant (any conditioning, any donor) at Dana-Farber Cancer Institute
  4. * Physician's clearance to participate in moderate-vigorous intensity exercise
  5. * Speak English
  6. * Currently participate in less than 60 minutes of structured exercise/week
  7. * Willing to travel to Dana-Farber Cancer Institute for necessary data collection
  8. * Ability to understand and the willingness to sign a written informed consent document.
  1. * Have a plan for hospital admission within the next 13 weeks at the time of recruitment
  2. * If patients are not enrolled within 7 days after initial steroid treatment, they will be ineligible
  3. * Pre-existing musculoskeletal or cardiorespiratory conditions
  4. * Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension, or thyroid disease
  5. * Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
  6. * Patients with other active malignancies
  7. * Participate in more than 60 minutes of structured exercise/week
  8. * Unable to travel to Dana-Farber Cancer Institute for necessary data collection
  9. * Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

Contacts and Locations

Study Contact

Christina Dieli-Conwright, PhD, MPH
CONTACT
617-582-8321
ChristinaM_Dieli-Conwright@dfci.harvard.edu
Mary Norris, MS
CONTACT
857-215-0195
maryk_norris@dfci.harvard.edu

Principal Investigator

Christina Dieli-Conwright
PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

  • Christina Dieli-Conwright, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

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 Date2022-04-14
Study Completion Date2025-10-31

Study Record Updates

Study Start Date2022-04-14
Study Completion Date2025-10-31

Terms related to this study

Keywords Provided by Researchers

  • Graft Vs Host Disease
  • Acute-graft-versus-host Disease
  • Chronic Graft-versus-host-disease
  • Corticosteroids
  • Allogeneic stem cell transplant

Additional Relevant MeSH Terms

  • Graft Vs Host Disease
  • Acute-graft-versus-host Disease
  • Chronic Graft-versus-host-disease