Reduce Sedentary Time in Acute Lymphoblastic Leukemia (NCT06182163) | Clinical Trial Compass
CompletedNot Applicable
Reduce Sedentary Time in Acute Lymphoblastic Leukemia
United States20 participantsStarted 2024-07-01
Plain-language summary
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.
Who can participate
Age range
12 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 li…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants enrolled at 6 months
Timeframe: 6 months
2
Number of participants who have completed all baseline and exit questionnaires at 12 weeks
Timeframe: 12 weeks
3
Average intervention participant fitness tracker wear time over 10 weeks
Timeframe: 10 weeks
4
Participant satisfaction with the sedentary time intervention at 12 weeks