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

Phase 3RecruitingNCT07186192

City of Hope Medical Center190 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

190

Conditions

Hematologic Malignancies

Interventions

Educational InterventionOTHER

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 TelemonitoringPROCEDURE

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

Questionnaire AdministrationOTHER

Ancillary studies

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 \-

Locations (1)

City of Hope Medical Center

Duarte, California, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

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

Secondary Outcomes

Montgomery Borgatta Caregiver Burden Scale (FCG)

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.

Time frame: Baseline, Day 30, Day 60, and Day 90

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

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.

Central Contacts

Virginia Sun, PhD, RN

CONTACT

626-218-3122 vsun@coh.org

Data from ClinicalTrials.gov

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