FitBit and coaching app aim to ease CAR-T side effects in landmark trial
NCT ID NCT07186192
First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 3 times
Summary
This study tests whether a digital health program—including a FitBit, a mobile app, and nurse coaching—can help 190 people receiving CAR-T therapy and their family caregivers better manage symptoms and distress. Participants will use the tools for 90 days while reporting their symptoms and stress levels. The goal is to see if this approach improves quality of life and reduces the burden of treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- digital health intervention (educational coaching, FitBit, mobile app)
- What this could lead to
- If it works, this could provide a practical way to reduce symptom burden and distress for people undergoing CAR-T therapy and their caregivers.
- What could go wrong
- This is a Phase 3 trial, but it tests a supportive intervention, not a cure. The benefits may be modest and depend on patient engagement with the app and coaching.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 380 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patient Inclusion Criteria Informed Consent and Willingness to Participate 1. Documented informed consent of the participant and/or legally authorized representative Age and Language Criteria 2. Age ≥ 18 years old at the time of enrollment 3. Ability to read and understand English or Spanish for Questionnaires Nature of Illness and Treatment Related Criteria 4. Relapsed or refractory hematologic malignancy 5. Scheduled to receive outpatient standard of care (SOC) CAR-T therapy 6. Has a FCG committed to living with the patient for the duration of the study Family Caregiver Inclusion Criteria Informed Consent and Willingness to Participate 1. Documented informed consent of the participant and/or legally authorized representative Age and Language Criteria 2. Age ≥ 18 years old at the time of enrollment 3. Ability to read and understand English or Spanish for Questionnaires Nature of Illness and Treatment Related Criteria 4. Family member or friend identified by the patient and defined as a person who knows the patient well and is involved in the patient's medical care Exclusion Criteria 1. An employee who is under the direct/indirect supervision of the PI/ a co-investigator/ the study manager 2. A direct study team member \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
Contacts and locations
Locations
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City of Hope Medical Center
RECRUITINGDuarte, California, 91010, United States
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