COMPLETED

Reduce Sedentary Time in Acute Lymphoblastic Leukemia

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 goal of this feasibility trial is to test if a mobile health intervention, including a wearable fitness tracker with inactivity-triggered reminders to move, individualized coaching sessions, and an app-based peer support group, can decrease sedentary time (time spent sitting/lying down and inactive) in adolescents and young adults (AYAs) with acute lymphoblastic leukemia (ALL) receiving maintenance chemotherapy. The main questions it aims to answer are: * Is the intervention a feasible and acceptable way to decrease sedentary time among adolescents and young adults (AYAs) with ALL? * Does the intervention show evidence that it may decrease sedentary time? * Does the intervention show evidence that it may increase quality of life, reduce inflammation, and improve glucose and lipid metabolism? Participants will use their fitness tracker with reminders to move as well as support from other intervention participants and coaching with study staff to gradually decrease their sedentary time over 10 weeks. Researchers will compare participant pre- and post-intervention study measures to see if the program may be helpful to decrease sedentary time in adolescents and young adults (AYAs) with ALL. All participants will wear an activity tracker on the thigh for 7 days at the beginning and end of the study as well as complete quality of life questionnaires. Study labs will be collected three times (baseline, 8 weeks, and 12 weeks) over the course of the 12-week study. All in-person study visits and labs will occur in conjunction with Oncology clinic visits for maintenance chemotherapy.

Official Title

ReSeT in ALL: A Single-arm Feasibility Trial Testing a Multi-component Mobile Health Intervention to Reduce Sedentary Time in Adolescents and Young Adults (AYAs) With ALL During Maintenance Therapy

Quick Facts

Study Start:2024-07-01
Study Completion:2025-12-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06182163

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:12 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * 12-21 years of age at time of enrollment
  2. * Diagnosis of lymphoblastic leukemia/lymphoma treated with Children's Oncology Group (COG)-based maintenance chemotherapy \[B-cell acute lymphoblastic leukemia/lymphoma (B-ALL/Ly), T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/Ly), mixed phenotype acute leukemia (MPAL)\]
  3. * Has completed at least one month of maintenance chemotherapy and has at least one cycle (3 months) remaining.
  4. * Baseline sedentary lifestyle with a self-reported average of 4 or more leisure-time hours per day spent sedentary (verbal report)
  5. * Willing to reduce their sedentary time
  6. * Parent/legal guardian available for consent (if applicable), and patient available for assent or consent as applicable
  7. * Has access to internet and smartphone compatible with Fitbit and WhatsApp (own or parent/legal guardian's)
  8. * Ability to participate in virtual sessions with study staff
  9. * Fluent in English (Parent/legal guardian does not need to be fluent in English as long as they can provide consent, if needed, in their primary language)
  1. * Evidence of recurrent or metastatic disease
  2. * Inability to obtain consent/assent
  3. * Medical contraindication to daily standing and light physical activity \[\>1.5 metabolic equivalents of task (METs)\]
  4. * Intellectual disability or developmental delay which limits ability to fully participate in the study intervention
  5. * Unable to obtain laboratory studies
  6. * Unable to accurately perform quality of life surveys independently
  7. * Unable to complete study-related surveys
  8. * Pregnancy or current imprisonment

Contacts and Locations

Principal Investigator

Brittany J Ivory (Van Remortel), MD, MPH
PRINCIPAL_INVESTIGATOR
Children's Hospital Los Angeles

Study Locations (Sites)

Children's Hospital Los Angeles
Los Angeles, California, 90027
United States

Collaborators and Investigators

Sponsor: Children's Hospital Los Angeles

  • Brittany J Ivory (Van Remortel), MD, MPH, PRINCIPAL_INVESTIGATOR, Children's Hospital Los Angeles

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 Date2024-07-01
Study Completion Date2025-12-10

Study Record Updates

Study Start Date2024-07-01
Study Completion Date2025-12-10

Terms related to this study

Keywords Provided by Researchers

  • Sedentary behavior(s)
  • sedentary time
  • physical inactivity
  • acute lymphoblastic leukemia (ALL)
  • adolescent(s)
  • mobile health (mHealth)

Additional Relevant MeSH Terms

  • Acute Lymphoblastic Leukemia (ALL)