Digital health program for self-management and remote monitoring during outpatient CAR-T therapy

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

This Phase 3 study tests whether a remote patient-monitoring and education program helps adults with relapsed or refractory blood cancers and their family caregivers manage symptoms during and after outpatient CAR-T therapy.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: City of Hope Medical Center (Academic / other)
• Drugs / interventions: CAR-T
• Locations: 1 site (Duarte, California)
• Trial ID: NCT07186192 on ClinicalTrials.gov

What this trial studies

This randomized, controlled Phase 3 trial will enroll 190 patients receiving outpatient standard-of-care CAR-T therapy and their family caregivers to compare usual care versus a multilevel intervention enhanced with remote patient monitoring (RPM), educational materials, telemonitoring, and structured questionnaires. The intervention combines real-time symptom telemetry, caregiver engagement, and best-practice clinical pathways to detect and respond to complications earlier. Outcomes will include clinical effects on symptom burden, adverse events, healthcare utilization, and caregiver-reported measures during and after CAR-T. The study is led by City of Hope Medical Center with support from the U.S. Department of Defense.

Who should consider this trial

Good fit: Adults (≥18) with relapsed or refractory hematologic malignancy who are scheduled for outpatient standard-of-care CAR-T therapy and have a committed family caregiver who can read English or Spanish are eligible.

Not a fit: Patients receiving inpatient CAR-T, those without a committed family caregiver, those unable to read English or Spanish, or those unable/unwilling to use remote monitoring are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the program could reduce severe side effects, improve symptom control, and provide better support for caregivers during and after outpatient CAR-T therapy.

How similar studies have performed: Remote patient monitoring and digital education have shown promise for symptom management in other oncology settings, but robust randomized Phase 3 evidence specifically in CAR-T recipients is limited.

Eligibility criteria

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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Where this trial is running

Duarte, California

• City of Hope Medical Center — Duarte, California, United States (Recruiting)

Study contacts

• Principal investigator: Virginia Sun, PhD, RN — City of Hope Medical Center
• Study coordinator: Virginia Sun, PhD, RN

Conditions Hematologic Malignancies; CAR-T; Digital health intervention