Reducing sedentary time in adolescents with acute lymphoblastic leukemia
ReSeT in ALL: A Single-arm Pilot Trial Testing a Multi-component Mobile Health Intervention to Reduce Sedentary Time in Adolescents and Young Adults (AYAs) With ALL During Maintenance Therapy
NA · Children's Hospital Los Angeles · NCT06182163
This study is testing a new mobile health program that uses a fitness tracker and coaching to help young people with leukemia move more and sit less during their treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 12 Years to 21 Years |
| Sex | All |
| Sponsor | Children's Hospital Los Angeles (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06182163 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial aims to evaluate a mobile health intervention designed to decrease sedentary time in adolescents and young adults (AYAs) with acute lymphoblastic leukemia (ALL) undergoing maintenance chemotherapy. Participants will receive a wearable fitness tracker that provides inactivity-triggered reminders, individualized coaching sessions, and access to an app-based peer support group over a 10-week period. The study will assess the feasibility and acceptability of this intervention, as well as its potential effects on sedentary behavior, quality of life, inflammation, and metabolic health. The trial will enroll 30 participants who will all receive the intervention.
Who should consider this trial
Good fit: Ideal candidates are adolescents and young adults aged 12-21 diagnosed with acute lymphoblastic leukemia who are currently receiving maintenance chemotherapy and have a sedentary lifestyle.
Not a fit: Patients who are not willing to reduce their sedentary time or do not have access to the necessary technology may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the physical activity levels and overall quality of life for adolescents and young adults with ALL.
How similar studies have performed: While this approach is innovative, similar interventions targeting sedentary behavior in cancer survivors have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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 cycle (3 months) of maintenance chemotherapy and has at least one cycle (3 months) remaining. Exception: Patients treated with nelarabine are eligible to enroll only after completion of nelarabine-containing cycles of maintenance therapy. * 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
Where this trial is running
Los Angeles, California
- Children's Hospital Los Angeles — Los Angeles, California, United States (RECRUITING)
Study contacts
- Principal investigator: Brittany J Van Remortel, MD, MPH — Children's Hospital Los Angeles
- Study coordinator: Brittany J Van Remortel, MD, MPH
- Email: bvanremortel@chla.usc.edu
- Phone: 323-376-1067
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Lymphoblastic Leukemia, Sedentary behavior, sedentary time, physical inactivity, acute lymphoblastic leukemia, adolescent, mobile health