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

Обзор

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.

Вмешательства

• Поведенческое ReSeT2 Intervention
  A 10-week multi-component mobile health sedentary behavior intervention that includes a Fitbit with inactivity prompts, home activity equipment, goal-based incentives, individualized coaching, a peer-support GroupMe chat, and optional in-person group sessions

Первичные конечные точки

• Change in Total Sedentary Time [Срок оценки: Baseline and Week 12 (change from Baseline to Week 12).]

Вторичные конечные точки (7)

• Change in Daily Sitting Time Measured by Accelerometry [Срок оценки: Baseline and Week 12 (change from Baseline to Week 12).]
• Change in Time Spent in Prolonged Sedentary Bouts [Срок оценки: Baseline and Week 12 (change from Baseline to Week 12).]
• Change in Daily Step Count [Срок оценки: Baseline and Week 12 (change from Baseline to Week 12).]
• Change in Self-Reported Sitting Time [Срок оценки: Baseline and Week 12 (change from Baseline to Week 12)]
• Study Retention Rate [Срок оценки: Up to Week 12.]
• Fitbit Wear Adherence [Срок оценки: Throughout the 10-week intervention period.]
• Intervention Acceptability Survey Responses [Срок оценки: Week 12]

Критерии участия

Критерии включения

• 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.
• Patients receiving nelarabine-containing maintenance cycles are eligible.
• Self-reported sedentary lifestyle with an average of 4 or more leisure-time hours per day spent sedentary.
• Willing to reduce sedentary time.
• Parent/legal guardian available for consent (if applicable) and participant available for assent/consent as applicable.
• Access to the internet and a smartphone compatible with Fitbit and GroupMe (participant's or parent/guardian's device).
• Ability to participate in virtual sessions with study staff.
• Fluent in English. (Parents/guardians do not need to be English-speaking if consent can be completed in their primary language.)

Критерии исключения

• 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.
• Unable to obtain study laboratory tests
• Unable to independently complete quality-of-life surveys accurately.
• Unable to complete study-related surveys.
• Pregnancy.
• Current imprisonment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07742891 · CHLA-26-00180

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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