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

NCT07186192 | Recruiting Phase 3 DMC

• 1 other identifier: 25328
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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

Keywords

CAR-T; Digital health intervention

Outcome Measures

Primary Outcomes (2)

• MD Anderson Symptom Inventory CAR-T module (MDASI-CAR - patient)

  This is validated measure of 22 CAR-T specific symptoms and other cancer-related symptoms. Symptom severity is rated on a 10-point scale: 1-3 mild, 4-6 moderate, ≥7 severe. Patients also rate how much their symptoms interfere with 6 functional domains: walking, activity, working/housework, relationships, enjoyment of life, and mood. A change in 1.2 points is clinically meaningful and cutoffs for clinical deficits have been defined. Cronbach's α reliability: 82-0.94.

  Baseline, Day 15 - Day 20 post-CAR-T, Day 30, Day 60, and Day 90

• Distress Thermometer (DT - FCG)

  This is an efficient, low-subject-burden measure to evaluate psychological distress over the past week, based on a scale of 0 (no distress) to 10 (extremely distressed). A cut-off of 3/10 indicates a need for intervention, with acceptable sensitivity (94.1%) and specificity (71.2%) compared to the longer Hospital Anxiety and Depression Scale (HADS). The DT has been validated in FCGs, and we chose it for its brevity, accuracy ease of use in remote monitoring, and validity in FCGs.

  Baseline, Day 15 - Day 20 post-CAR-T, Day 30, Day 60, and Day 90

Secondary Outcomes (2)

• Montgomery Borgatta Caregiver Burden Scale (FCG)

  Baseline, Day 30, Day 60, and Day 90

• Functional Assessment of Cancer Therapy-General (FACTG - patient)

  Baseline, Day 30, Day 60, and Day 90

Other Outcomes (11)

• COH-QoL-Family (FCG)

  Baseline, Day 30, Day 60, and Day 90

• Brief Dyadic Adjustment Scale (DAS - patient, FCG)

  Baseline, Day 30, Day 60, and Day 90

• FCG Activation in Transitions Tool (FCAT - FCG)

  Baseline, Day 30, Day 60, and Day 90

Study Arms (2)

Arm A - self-management coaching, telemonitoring

EXPERIMENTAL

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.

Other: Educational Intervention; Procedure: Health Telemonitoring; Other: Questionnaire Administration

Arm B - Standard of Care Arm ( Enhanced usual care)

ACTIVE COMPARATOR

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

Other: Questionnaire Administration; Other: Best Practice

Interventions

Educational 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

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm A - self-management coaching, telemonitoring

Health Telemonitoring PROCEDURE

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

Arm A - self-management coaching, telemonitoring

Questionnaire Administration OTHER

Ancillary studies

Arm A - self-management coaching, telemonitoring; Arm B - Standard of Care Arm ( Enhanced usual care)

Best Practice OTHER

Given usual care

Also known as: best practice, standard of care, standard of care, standard of care, standard therapy

Arm B - Standard of Care Arm ( Enhanced usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• United States Department of Defense: collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Early Intervention, Educational; Educational Status; Methods; Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Virginia Sun, PhD, RN

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

• Saro Armenian, DO, MPH

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Virginia Sun, PhD, RN

CONTACT

626-218-3122; vsun@coh.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: September 22, 2025
• Study Start: January 14, 2026
• Primary Completion (Estimated): March 29, 2029
• Study Completion (Estimated): March 29, 2029
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

US (1)