Clinical trial · Interventional
Digital Health Intervention for Self-Management and Telemonitoring in Chimeric Antigen Receptor (CAR-T) Therapy
Digital Health Intervention for Self-Management and Telemonitoring in Chimeric Antigen Receptor-T Cell (CAR-T)Therapy
NCT07186192CI-TRIAL-00124484recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Educational Intervention | Other | — | UNRESOLVED |
| Health Telemonitoring | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A - self-management coaching, telemonitoring
- description
- 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.
- interventionNames
- Other: Educational Intervention
- Procedure: Health Telemonitoring
- Other: Questionnaire Administration
- type
- ACTIVE_COMPARATOR
- label
- Arm B - Standard of Care Arm ( Enhanced usual care)
- description
- Patients and their FCGs receive usual care, including standard print educational materials on study.
- interventionNames
- Other: Questionnaire Administration
- Other: Best Practice
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 \-
References
Publications (0)
Data not yet available
No reference posted for this study.