Clinical trial · Interventional
Reduce Sedentary Time in Acute Lymphoblastic Leukemia
ReSeT in ALL: A Single-arm Feasibility Trial Testing a Multi-component Mobile Health Intervention to Reduce Sedentary Time in Adolescents and Young Adults (AYAs) With ALL During Maintenance Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia (ALL) | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sedentary time intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sedentary time intervention
- interventionNames
- Behavioral: Sedentary time intervention
Primary outcomes (4)
- measure
- Number of participants enrolled at 6 months
- timeFrame
- 6 months
- description
- 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.
- measure
- Number of participants who have completed all baseline and exit questionnaires at 12 weeks
- timeFrame
- 12 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
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