NCT07186192 Digital Health Intervention for Self-Management and Telemonitoring in Chimeric Antigen Receptor (CAR-T) Therapy
| NCT ID | NCT07186192 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | City of Hope Medical Center |
| Condition | Hematologic Malignancies |
| Study Type | INTERVENTIONAL |
| Enrollment | 190 participants |
| Start Date | 2026-01-14 |
| Primary Completion | 2029-03-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 190 participants in total. It began in 2026-01-14 with a primary completion date of 2029-03-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 \-
Contact & Investigator
Virginia Sun, PhD, RN
PRINCIPAL INVESTIGATOR
City of Hope Medical Center
Frequently Asked Questions
Who can join the NCT07186192 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hematologic Malignancies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07186192 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 190 participants.
Is NCT07186192 currently recruiting?
Yes, NCT07186192 is actively recruiting participants. Contact the research team at vsun@coh.org for enrollment information.
Where is the NCT07186192 trial being conducted?
This trial is being conducted at Duarte, United States.
Who is sponsoring the NCT07186192 clinical trial?
NCT07186192 is sponsored by City of Hope Medical Center. The principal investigator is Virginia Sun, PhD, RN at City of Hope Medical Center. The trial plans to enroll 190 participants.