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Fighting sedentary time in young cancer patients: a digital intervention put to the test

NCT ID NCT07742891

Symptom relief Sponsor: Children's Hospital Los Angeles Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial tests whether a 10-week mobile health program, called ReSeT2, can reduce the time adolescents and young adults with acute lymphoblastic leukemia (ALL) spend sitting during maintenance therapy. Participants aged 13-22 will be randomly assigned to either the intervention—which includes a Fitbit with inactivity prompts, home activity equipment, coaching, and peer support—or usual care. The study measures changes in sedentary time and explores effects on cardiometabolic health and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A 10-week mobile health intervention combining a Fitbit with inactivity prompts, home activity equipment, goal-based incentives, coaching, and peer support
What this could lead to
If effective, this approach could offer a practical way to reduce sedentary time and improve cardiometabolic health in young leukemia patients during maintenance therapy.
What could go wrong
This is a small pilot study, so results may not be conclusive. The intervention's success depends on participant engagement, and it may not lead to lasting changes or generalizable outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

13 to 22 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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.) Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Sedentary Behavior

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute lymphoblastic leukemia (ALL) Cardiometabolic health Sedentary behavior / physical inactivity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.