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

Not Applicable

Recruiting

• Conditions: Hematologic Malignancies

• Registration Number: NCT07186192
• Lead Sponsor: City of Hope Medical Center

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-09-07
• Study First Submitted QC: 2025-09-12
• Study First Posted: 2025-09-22
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-27
• Last Update Posted: 2025-10-29
• Study Start: 2025-12-15
• Primary Completion: 2029-03-29
• Study Completion: 2029-03-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

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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Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
MD Anderson Symptom Inventory CAR-T module (MDASI-CAR - patient)	Baseline, Day 15 - Day 20 post-CAR-T, Day 30, Day 60, and Day 90	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.
Distress Thermometer (DT - FCG)	Baseline, Day 15 - Day 20 post-CAR-T, Day 30, Day 60, and Day 90	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.

Secondary Outcome Measures

Name	Time	Method
Montgomery Borgatta Caregiver Burden Scale (FCG)	Baseline, Day 30, Day 60, and Day 90	This is a 14-item tool designed to measure the impact of caregiving on three dimensions of burden: objective, subjective demand, and subjective stress. Internal consistency for the three dimensions ranges from 0.81-0.90. The ordinal scale ranges from 1-5 (a lot less to a lot more). The following cutoff scores are interpreted as high burden: 1) a score of ≥23 for objective burden, 2) a score of ≥15 for subjective demand, and 3) a score of ≥13.5 for subjective stress.
Functional Assessment of Cancer Therapy-General (FACTG - patient)	Baseline, Day 30, Day 60, and Day 90	This is a cancer-specific version of the FACIT (Functional Assessment of Chronic Illness Therapy) Measurement System. It contains a 27-item compilation of general questions divided into four QoL domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. For each item, the respondent indicates on a 5-point Likert scale (0=not at all; 4=very much) how true each statement is for him/her during the past 7d. The FACT-G yields a total score for overall QoL as well as subscale scores. Internal consistency and reliability measures revealed a Cronbach's α of 0.89 for the total FACT-G, and a range of 0.70-0.82 for the four subscales.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States