Digital Health Intervention for Self-Management and Telemonitoring in Chimeric Antigen Receptor (CAR-T) Therapy
NCT ID: NCT07186192
Last Updated: 2026-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
190 participants
INTERVENTIONAL
2026-01-14
2029-03-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm A - self-management coaching, telemonitoring
Patients and their FCGs participate in self-management coaching sessions over 60 minutes each prior to CAR-T infusion and at approximately days 21, 42, and 70 post-CAR-T infusion. Beginning 15-20 days post CAR-T infusion, participants wear a FitBit device and use a mobile app QD three times per week for 90 days for tracking by nurses of daily steps, temperature, blood pressure, oxygen level, weight, and distress levels.
Educational Intervention
Patients and family caregivers that are randomized into the intervetnion arm (Digital health intervention) will receive a 90 day nurse-drive, digital health intervention. Participate in self-management coaching sessions
Health Telemonitoring
Wear a FitBit device and use a mobile app for nurse tracking
Questionnaire Administration
Ancillary studies
Arm B - Standard of Care Arm ( Enhanced usual care)
Patients and their FCGs receive usual care, including standard print educational materials on study.
Questionnaire Administration
Ancillary studies
Best Practice
Given usual care
Interventions
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Educational Intervention
Patients and family caregivers that are randomized into the intervetnion arm (Digital health intervention) will receive a 90 day nurse-drive, digital health intervention. Participate in self-management coaching sessions
Health Telemonitoring
Wear a FitBit device and use a mobile app for nurse tracking
Questionnaire Administration
Ancillary studies
Best Practice
Given usual care
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
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
18 Years
ALL
Yes
Sponsors
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United States Department of Defense
FED
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Virginia Sun, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Saro Armenian, DO, MPH
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Central Contacts
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Other Identifiers
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25328
Identifier Type: -
Identifier Source: org_study_id
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