ReSeT in ALL 2: A Randomized, Controlled Pilot Trial Testing an Optimized, Multi-component Mobile Health Intervention to Reduce Sedentary Time in Early Adolescents and Young Adults (eAYAs) With ALL During Maintenance Therapy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-22
SponsorChildren's Hospital Los Angeles

About this trial

The goal of this clinical trial is to learn whether an optimized, multi-component mobile health intervention (ReSeT2) can reduce sedentary behavior in adolescents and young adults with acute lymphoblastic leukemia (ALL) who are receiving maintenance therapy. The participant population includes English-speaking adolescents and young adults aged 13-22 years with ALL or related lymphoid malignancies being treated at Children's Hospital Los Angeles.

The main questions it aims to answer are:

* Does the ReSeT2 intervention reduce device-measured total sedentary time (minutes/day) from baseline to Week 12 compared with usual care? * Does the ReSeT2 intervention improve other sedentary behavior measures, feasibility and acceptability outcomes, and exploratory health outcomes such as cardiometabolic health, quality of life, and self-efficacy?

Researchers will compare participants receiving the ReSeT2 intervention with participants receiving usual care to see if the intervention leads to greater reductions in sedentary time and improvements in related health outcomes.

Participants will:

* Complete baseline and Week 12 assessments, including questionnaires, clinical measurements, laboratory tests, and 7-day accelerometer wear periods. * Be randomized to either the ReSeT2 intervention group or usual care. * If assigned to the intervention group:

Use a Fitbit activity tracker with inactivity prompts for 10 weeks. Receive home activity equipment and goal-based incentives. Participate in individualized coaching sessions. Participate in a peer support GroupMe chat and optional in-person group sessions.

If assigned to the usual care group, continue standard clinical care and complete study assessments.

Eligibility criteria

Qualifiers

Age 13-22 years at the time of enrollment.

Diagnosis of lymphoblastic leukemia or lymphoma treated with Children's Oncology Group (COG)-based maintenance chemotherapy (B-ALL, T-ALL, MPAL).

Patients with a history of relapsed disease are eligible if currently in second (or greater) remission and receiving COG-based maintenance therapy.

Completed at least 1 month of maintenance therapy (through maintenance cycle 1, day 29) and have at least one maintenance cycle (approximately 3 months) remaining.

Disqualifiers

Evidence of recurrent or metastatic disease.

Inability to obtain informed consent/assent.

Medical contraindication to daily standing and light physical activity (>1.5 METs).

Intellectual disability or developmental delay that limits the ability to fully participate in the study intervention.

Trial design

Treatments tested in this trial

  • ReSeT2 Intervention

Treatment groups

50 Participants
are divided into 2 treatment groups

Locations

This trial has no locations