Currently submitted to: JMIR Cancer
Date Submitted: May 9, 2026
Open Peer Review Period: May 20, 2026 - Jul 15, 2026
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Pilot Study of an On-Therapy, Clinically Integrated Mobile Health Intervention to Reduce Sedentary Time in Early Adolescents and Young Adults with Acute Lymphoblastic Leukemia
ABSTRACT
Background:
Sedentary behavior (SB) is prevalent among early adolescents and young adults (eAYAs; ages 12–21 years) with acute lymphoblastic leukemia (ALL) and contributes to adverse cardiometabolic and health-related quality-of-life (HRQoL) outcomes. However, SB-focused interventions during active therapy are lacking.
Objective:
This trial aimed to evaluate the feasibility and acceptability of a 10-week, multi-component mobile health (mHealth) intervention among eAYAs receiving maintenance therapy for ALL.
Methods:
This 12-week, single-arm study enrolled 20 eAYAs with ALL receiving maintenance therapy. The 10-week intervention included a wearable activity tracker with inactivity-triggered prompts, individualized coaching sessions, and an app-based peer support group. The intervention was integrated into routine maintenance therapy by aligning the study timeline, visits, and procedures with a single maintenance therapy cycle. Primary endpoints were feasibility (defined by participant retention) and acceptability (via exit surveys and interviews). Secondary endpoints included pre-post intervention changes in device-measured and self-reported SB; exploratory analyses evaluated changes in cardiometabolic biomarkers and HRQoL.
Results:
Among the 20 participants, there was a 95% retention rate and a high level of intervention acceptability, with 95% reporting the intervention helped reduce SB and 100% recommending it to peers with cancer. Although statistically significant changes in device-measured sedentary time were not detected, there were notable decreases in prolonged sedentary bouts of 1 hour or more (−22.5 min/day, P=.59) and increases in daily steps (+49.5 steps/day, P=.39). Self-reported sitting time significantly decreased (−154 min/day, P=.006). No statistically significant changes were detected in cardiometabolic biomarkers; however, significant improvements were observed in HRQoL domains of physical functioning (+3.1, P=.04) and sleep/rest fatigue (+8.3, P=.05).
Conclusions:
This novel SB intervention met predetermined feasibility and acceptability criteria and demonstrated potential to reduce SB among eAYAs receiving ALL maintenance therapy, supporting further evaluation in larger trials. Clinical Trial: ClinicalTrials.gov: NCT06182163.
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