What this study is
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).
What's being tested
- Educational Intervention
Intervention · OTHER
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
- Health Telemonitoring
Intervention · PROCEDURE
Wear a FitBit device and use a mobile app for nurse tracking
- Questionnaire Administration
Intervention · OTHER
Ancillary studies
- Best Practice
Intervention · OTHER
Given usual care
Study details
- Official title
- Digital Health Intervention for Self-Management and Telemonitoring in Chimeric Antigen Receptor-T Cell (CAR-T)Therapy
- Sponsor
- City of Hope Medical Center
- Conditions
- Hematologic Malignancies
- Enrolling
- 380 people
- Starts
- 2026-01-14
- Est. completion
- 2029-03-29
- Design
- Open-label, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedPatient
You may qualify if
- Informed Consent and Willingness to Participate
- 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
Family Caregiver
You may qualify if
- Informed Consent and Willingness to Participate
- 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 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 -
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openCity of Hope Medical Center
Duarte, California, United States
Recruiting
Study team
Sponsor
City of Hope Medical Center
Study ID 25328
Principal investigator
Virginia Sun, PhD, RN
City of Hope Medical Center
Principal investigator
Saro Armenian, DO, MPH
City of Hope Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.