Digital Health Intervention for Self-Management and Telemonitoring in Chimeric Antigen Receptor (CAR-T) Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Educational Intervention, Health Telemonitoring, Questionnaire Administration, Best Practice.
- Who it may be relevant to
- Registry conditions: Hematologic Malignancies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Digital Health Intervention for Self-Management and Telemonitoring in Chimeric Antigen Receptor-T Cell (CAR-T)Therapy
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).
Interventions
- Other 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 - Procedure Health Telemonitoring
Wear a FitBit device and use a mobile app for nurse tracking - Other Questionnaire Administration
Ancillary studies - Other Best Practice
Given usual care
Primary outcome measures
- 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]
Secondary outcome measures (2)
- Montgomery Borgatta Caregiver Burden Scale (FCG) [Time frame: Baseline, Day 30, Day 60, and Day 90]
- Functional Assessment of Cancer Therapy-General (FACTG - patient) [Time frame: Baseline, Day 30, Day 60, and Day 90]
Eligibility criteria
Inclusion criteria
Patient Inclusion Criteria Informed Consent and Willingness to Participate
- 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
Family Caregiver Inclusion Criteria Informed Consent and Willingness to Participate
- 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
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
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- City of Hope Medical Center — Duarte
Identifiers
NCT: NCT07186192 · 25328