NCT06665295

THRIVE-CAR-T Digital App

Randomized Controlled Trial of a Supportive Care Digital Application (THRIVE-CAR-T) for Patients Receiving CAR-T Cell Therapy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Patrick C. Johnson, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if a digital mobile application called THRIVE-CAR-T is helpful for the care of patients undergoing CAR-T cell therapy. The main question\[s\] it aims to answer are whether the THRIVE-CAR-T app is feasible and acceptable to patients.

Detailed description

This pilot randomized controlled trial aims to examine the feasibility, acceptability, and preliminary effects of a supportive care digital app (THRIVE-CAR-T) versus usual care in patients receiving chimeric antigen receptor T-cell therapy (CAR-T). The primary objective of the study is to determine if THRIVE-CAR-T is feasible and acceptable to patients. The exploratory objective is to assess the preliminary effects of THRIVE-CAR-T for improving patient-reported quality of life (QOL), psychological distress, and self efficacy.

Conditions

• CAR T-Cell Therapy

Interventions

Type	Name	Description
BEHAVIORAL	THRIVE-CAR-T	The intervention will begin several weeks prior to CAR-T cell therapy and will continue up until 30 days post CAR-T cell therapy. THRIVE-CAR-T is an educational and interactive digital application on an iPad for patients as they navigate receiving CAR-T. THRIVE-CAR-T is self-administered and provides education about the CAR-T cell therapy process, with several features to promote coping skills training informed by various well-established supportive psychotherapy strategies (e.g., cognitive behavior therapy, mindfulness, positive psychology), engagement, and health behavior change including gamification strategies, videos of patients who received CAR-T, and optional content.

Timeline

• Start date: 2024-10-17
• Primary completion: 2026-11-01
• Completion: 2026-12-31
• First posted: 2024-10-30
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States