Randomized Controlled Trial of a Supportive Care Digital Application (THRIVE-CAR-T) for Patients Receiving CAR-T Cell Therapy
Patrick C. Johnson, MD
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 18 years or older 2. Ability to understand English 3. Diagnosis of a hematologic malignancy 4. Receiving autologous CAR-T at MGH with an FDA approved cellular therapy product Exclusion Criteria: 1. Impaired cognition or uncontrolled mental illness that prohibits the ability to provide informed consent based on the oncology clinician assessment 2. Already participating in another supportive care clinical trial
Interventions
- BehavioralTHRIVE-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.
Location
- Massachusetts General HospitalBoston, Massachusetts