Reduce Sedentary Time (ReSeT) in Acute Lymphoblastic Leukemia (ALL)

Acute Lymphoblastic Leukemia (ALL) Clinical Trial

Official title: ReSeT in ALL: A Randomized Controlled Pilot Trial Testing a Multi-component Mobile Health Intervention to Reduce Sedentary Time in Adolescents With ALL During Maintenance Therapy

Status Not yet recruiting

Clinical Trial Summary

The goal of this randomized clinical trial is to test if a mobile health intervention, including a wearable fitness tracker with 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 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 with ALL?

• Does the intervention show evidence that it may decrease sedentary time, increase quality of life, and improve blood glucose control and inflammation?

Participants in the intervention group 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 the intervention group to a control group that receives education only to see if the intervention may be helpful to decrease sedentary time in adolescents 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 (monthly) 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.

Clinical Trial Description

Sedentary behaviors are highly prevalent among adolescents with acute lymphoblastic leukemia (ALL) and may worsen the cardiometabolic effects and deconditioning commonly associated with therapy. Replacing sedentary time (ST) with short bouts of light activity has been shown to reduce adiposity and improve glucose metabolism. This randomized, controlled pilot trial tests the feasibility and acceptability of a 10-week, multi-component mobile health ST intervention in adolescents with ALL and will inform future larger studies. Thirty participants will be enrolled and randomized to the intervention or control group. The intervention group will receive a wearable fitness tracker with prompts to move and participate in an app-based peer support group and individualized coaching sessions. The control group will receive educational materials only. Primary endpoints are intervention feasibility and acceptability. As secondary endpoints, this trial will also evaluate trends of efficacy of the intervention to: 1)reduce device-measured and self-reported ST, 2)improve short-term glucose metabolism and inflammation, and 3) improve health-related quality of life and fatigue among intervention versus control participants. Feasibility will be measured by recruitment rate, fitness tracker wear time, and retention rate; acceptability will be measured quantitatively via study exit surveys and qualitatively among intervention participants with exit interviews. Interim analysis will be completed once half of the enrollment goal has been reached (15) in order to inform future study, and final analysis will be completed once all 30 participants have completed. ;

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia (ALL)
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

• NCT number: NCT06182163
• Study type: Interventional
• Source: Children's Hospital Los Angeles
• Contact: Brittany J Van Remortel, MD, MPH
• Phone: 323-376-1067
• Email: bvanremortel@chla.usc.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 5, 2024
• Completion date: November 4, 2024