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

NCT07186192 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2026-01-28

No results posted yet for this study

Summary

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).

Conditions

Interventions

OTHER

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

PROCEDURE

Health Telemonitoring

Wear a FitBit device and use a mobile app for nurse tracking

OTHER

Questionnaire Administration

Ancillary studies

OTHER

Best Practice

Given usual care

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED
  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Virginia Sun, PhD, RN · City of Hope Medical Center

  • Saro Armenian, DO, MPH · City of Hope Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-14
Primary Completion
2029-03-29
Completion
2029-03-29

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07186192 on ClinicalTrials.gov