Status:
ACTIVE_NOT_RECRUITING
Reduce Sedentary Time in Acute Lymphoblastic Leukemia
Lead Sponsor:
Children's Hospital Los Angeles
Collaborating Sponsors:
St. Baldrick's Foundation
Rally Foundation for Childhood Cancer Research
Conditions:
Acute Lymphoblastic Leukemia (ALL)
Eligibility:
All Genders
12-21 years
Phase:
NA
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 a...
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 associ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06182163
Start Date
July 1 2024
End Date
January 1 2026
Last Update
October 14 2025
Active Locations (1)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027