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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: vsun@coh.org
• Phone: 626-218-3122

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.