RecruitingPhase 3NCT07186192

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

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


Sponsor

City of Hope Medical Center

Enrollment

190 participants

Start Date

Jan 14, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria10

  • Documented informed consent of the participant and/or legally authorized representative Age and Language Criteria
  • Age ≥ 18 years old at the time of enrollment
  • Ability to read and understand English or Spanish for Questionnaires Nature of Illness and Treatment Related Criteria
  • Relapsed or refractory hematologic malignancy
  • Scheduled to receive outpatient standard of care (SOC) CAR-T therapy
  • Has a FCG committed to living with the patient for the duration of the study
  • Documented informed consent of the participant and/or legally authorized representative Age and Language Criteria
  • Age ≥ 18 years old at the time of enrollment
  • Ability to read and understand English or Spanish for Questionnaires Nature of Illness and Treatment Related Criteria
  • 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 Criteria1

  • \-

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Interventions

OTHEREducational 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

PROCEDUREHealth Telemonitoring

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

OTHERQuestionnaire Administration

Ancillary studies

OTHERBest Practice

Given usual care


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT07186192


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