Reduce Sedentary Time in Acute Lymphoblastic Leukemia

NCT06182163 | Completed

• 1 other identifier: CHLA-23-00346
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Lymphoblastic Leukemia (ALL)

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Number of participants enrolled at 6 months

  Recruitment rate will serve as one of the primary markers of study feasibility to inform future trials. Number of participants recruited per week will be tracked to calculate the total participants enrolled at 6 months.

  6 months

• Number of participants who have completed all baseline and exit questionnaires at 12 weeks

  Retention rate will also be a defining measure of study feasibility. Number of participants who complete all questionnaires at baseline and 12 weeks will be divided by the total number of participants to determine the retention rate.

  12 weeks

• Average intervention participant fitness tracker wear time over 10 weeks

  Fitness tracker (Fitbit) wear time for each participant will be measured by the number of hours per day with detectable heart rate measurement. Total hours of fitness tracker wear time will be divided by total number of intervention days to calculate average daily wear time.

  10 weeks

• Participant satisfaction with the sedentary time intervention at 12 weeks

  Participant acceptability of the sedentary time intervention will be assessed via exit surveys and semi-structured qualitative interviews with study participants at the end of the 12-week study period. The exit survey will assess participants' opinions on the perceived effectiveness of the intervention overall, as well as each intervention component (Fitbit with reminders to move, coaching sessions, app-based per support group), via Likert-scale questions.

  12 weeks

Secondary Outcomes (2)

• Change in average minutes per day of sedentary time from baseline to 12 weeks

  12 Weeks

• Change in average hours per day of uninterrupted sedentary time from baseline to 12 weeks

  12 Weeks

Other Outcomes (11)

• Change in hemoglobinA1c level from baseline to 12 weeks

  12 weeks

• Change in fructosamine level from baseline to 8 weeks

  8 weeks

• Change in fructosamine level from baseline to 12 weeks

  12 weeks

Study Arms (1)

Sedentary time intervention

EXPERIMENTAL

Behavioral: Sedentary time intervention

Interventions

Sedentary time intervention BEHAVIORAL

Tests the effect of a multi-component mobile health (mHealth) intervention on reducing sedentary behavior among adolescents and young adults (AYAs) with ALL during maintenance therapy. The intervention includes an app-based peer support group for study participants via WhatsApp, individualized coaching sessions with study staff, and prompts to move delivered via a Fitbit wearable fitness tracker.

Sedentary time intervention

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 month of maintenance chemotherapy and has at least one cycle (3 months) remaining.
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rally Foundation for Childhood Cancer Research: collaborator
• Children's Hospital Los Angeles: lead
• St. Baldrick's Foundation: collaborator

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Sedentary Behavior

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Behavior

Study Officials

• Brittany J Ivory (Van Remortel), MD, MPH

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Pediatrics, Attending Physician

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 26, 2023
• Study Start: July 1, 2024
• Primary Completion: December 10, 2025
• Study Completion: December 10, 2025
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)