Reduce Sedentary Time in Acute Lymphoblastic Leukemia

Description

The goal of this pilot clinical 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.

Conditions

Acute Lymphoblastic Leukemia (ALL)

Study Overview

Study Details

Study overview

The goal of this pilot clinical 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.

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

Reduce Sedentary Time in Acute Lymphoblastic Leukemia

Condition
Acute Lymphoblastic Leukemia (ALL)
Intervention / Treatment

-

Contacts and Locations

Los Angeles

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 12-21 years of age at time of enrollment
  • * Diagnosis of lymphoblastic leukemia/lymphoma treated with Children's Oncology Group (COG)-based maintenance chemotherapy \[B-cell acute lymphoblastic leukemia/lymphoma (B-ALL/Ly), T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/Ly), mixed phenotype acute leukemia (MPAL)\]
  • * Has completed at least one cycle (3 months) of maintenance chemotherapy and has at least one cycle (3 months) remaining. Exception: Patients treated with nelarabine are eligible to enroll only after completion of nelarabine-containing cycles of maintenance therapy.
  • * Baseline sedentary lifestyle with a self-reported average of 4 or more leisure-time hours per day spent sedentary (verbal report)
  • * Willing to reduce their sedentary time
  • * Parent/legal guardian available for consent (if applicable), and patient available for assent or consent as applicable
  • * Has access to internet and smartphone compatible with Fitbit and WhatsApp (own or parent/legal guardian's)
  • * Ability to participate in virtual sessions with study staff
  • * 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)
  • * Evidence of recurrent or metastatic disease
  • * Inability to obtain consent/assent
  • * Medical contraindication to daily standing and light physical activity \[\>1.5 metabolic equivalents of task (METs)\]
  • * Intellectual disability or developmental delay which limits ability to fully participate in the study intervention
  • * Unable to obtain laboratory studies
  • * Unable to accurately perform quality of life surveys independently
  • * Unable to complete study-related surveys
  • * Pregnancy or current imprisonment

Ages Eligible for Study

12 Years to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Hospital Los Angeles,

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

Study Record Dates

2025-06-01