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

Plain-language summary

This Phase 3 randomized controlled trial examines the clinical effect of a multilevel intervention enhanced by remote patient monitoring (RPM) during and after outpatient CAR-T therapy. The intervention combines education, health telemonitoring and questionnaires and is compared with standard care. It involves 190 patients and their family caregivers; patients must be 18 or older, provide informed consent, and be able to read and understand English.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Recruiting

Sponsor

City of Hope Medical Center

Intervention

Educational Intervention (Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational), Health Telemonitoring, Questionnaire Administration, Best Practice (best practice, standard of care, standard of care, standard of care, standard therapy)

Start date

1/14/2026

Estimated completion

3/29/2029

Countries

United States

Related genes

Locations

• Duarte, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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

\-