Digital Health Intervention for Self-Management and Telemonitoring in Chimeric Antigen Receptor (CAR-T) Therapy

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07186192
Phase
PHASE3
Status
Recruiting
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Conditions

  • Hematologic Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Educational Intervention — OTHER
    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 — PROCEDURE
    Wear a FitBit device and use a mobile app for nurse tracking
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Best Practice — OTHER
    Given usual care

Study Details

The overall purpose of this randomized control trial (RCT) is to determine the clinical effect of a multilevel, RPM-enhanced intervention during and after completion of outpatient CAR-T therapy in 190 patients and their family caregivers (FCGs).

Key Dates

Start date
Jan 14, 2026
Status verified
Jan 2026
Primary completion
Mar 29, 2029
Completion
Mar 29, 2029

Study Design

Enrollment
190 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.
  • Active Comparator: Arm B - Standard of Care Arm ( Enhanced usual care)
    Patients and their FCGs receive usual care, including standard print educational materials on study.

Primary Outcome Measure

MD Anderson Symptom Inventory CAR-T module (MDASI-CAR - patient) [ Time Frame: Baseline, Day 15 - Day 20 post-CAR-T, Day 30, Day 60, and Day 90 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-

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