Recruiting
Phase 3

RPM-Enhanced Intervention

Sponsor:

City of Hope Medical Center

Code:

NCT07186192

Conditions

Hematologic Malignancies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Educational Intervention

Health Telemonitoring

Questionnaire Administration

Best Practice

Study Details

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).

Conditions

Hematologic Malignancies

Study ID

NCT07186192

Start date

Jan 14, 2026

Status verified date

Aug, 2026

Completion date

Mar 29, 2029

Anticipated

Primary completion date

Mar 29, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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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Study Design

Enrollment

380 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm A - self-management coaching, telemonitoring

Patients and their FCGs participate in self-management coaching sessions over 60 minutes each prior to CAR-T infusion and at approximately days 21, 42, and 70 post-CAR-T infusion. Beginning 15-20 days post CAR-T infusion, participants wear a FitBit device and use a mobile app QD three times per week for 90 days for tracking by nurses of daily steps, temperature, blood pressure, oxygen level, weight, and distress levels.

active comparator: Arm B - Standard of Care Arm ( Enhanced usual care)

Patients and their FCGs receive usual care, including standard print educational materials on study.

Interventions

Educational Intervention

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

Wear a FitBit device and use a mobile app for nurse tracking

Questionnaire Administration

Ancillary studies

Best Practice

Given usual care

Primary outcome measure

  • MD Anderson Symptom Inventory CAR-T module (MDASI-CAR - patient) [ Time Frame: Baseline, Day 15 - Day 20 post-CAR-T, Day 30, Day 60, and Day 90 ]
  • Distress Thermometer (DT - FCG) [ Time Frame: Baseline, Day 15 - Day 20 post-CAR-T, Day 30, Day 60, and Day 90 ]

Central Contacts and Locations

Central contacts

Virginia Sun, PhD, RN

626-218-3122vsun@coh.org

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

More Information

Sponsor

City of Hope Medical Center

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • CAR-T
  • Digital health intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-08-28.