Reduce Sedentary Time in Acute Lymphoblastic Leukemia

NCT ID: NCT06182163

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-01-01

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.

Detailed Description

Sedentary behaviors are highly prevalent among adolescents and young adults (AYAs) with acute lymphoblastic leukemia (ALL) and may worsen the cardiometabolic effects and deconditioning commonly associated with therapy. Additionally, sedentary lifestyles often persistent in to adulthood, increasing risk of chronic disease and early mortality in cancer survivors. Replacing sedentary time (ST) with short bouts of light activity has been shown to reduce adiposity and improve glucose metabolism. In adults, it has also been shown to decrease cancer incidence and cancer-specific mortality.

This pilot trial tests the feasibility and acceptability of a 10-week, multi-component mobile health ST intervention in adolescents and young adults (AYAs) with ALL and will inform future larger studies. Thirty participants will be enrolled and all will receive the intervention. They will receive a wearable fitness tracker with inactivity-triggered prompts to move and participate in an app-based peer support group as well as individualized coaching sessions.

Primary endpoints are intervention feasibility and acceptability. As a secondary endpoint, the trial will also evaluate if the intervention shows evidence that it may reduce device-measured and self-reported ST. Exploratory endpoints include the intervention's effect on participants' glucose and lipid metabolism, level of inflammation, and health-related quality of life and fatigue. 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.

Conditions

Acute Lymphoblastic Leukemia (ALL)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Sedentary time intervention

Group Type: EXPERIMENTAL

Sedentary time intervention

Intervention Type: 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.

Interventions

Sedentary time intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion 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 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Baldrick's Foundation

OTHER

Sponsor Role: collaborator

Rally Foundation for Childhood Cancer Research

OTHER

Sponsor Role: collaborator

Children's Hospital Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Brittany Van Remortel

Instructor of Pediatrics, Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brittany J Ivory (Van Remortel), MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Locations

Children's Hospital Los Angeles

Los Angeles, California, United States

Countries

United States

Other Identifiers

CHLA-23-00346

Identifier Type: -

Identifier Source: org_study_id