THRIVE-CAR-T mobile app to support people receiving CAR T therapy
Randomized Controlled Trial of a Supportive Care Digital Application (THRIVE-CAR-T) for Patients Receiving CAR-T Cell Therapy
The trial will test whether the THRIVE-CAR-T mobile app helps adults receiving CAR T-cell therapy manage symptoms, improve quality of life, and feel more confident in their care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | CAR-T, chimeric antigen receptor |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06665295 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial compares the THRIVE-CAR-T supportive care mobile app to usual care for adults undergoing autologous CAR-T therapy at Massachusetts General Hospital. Participants are randomized to use the app or receive standard supportive care, with patient-reported outcomes collected during the peri-infusion period. The primary aims are to determine feasibility and acceptability, while exploratory analyses will look at preliminary effects on quality of life, psychological distress, and self-efficacy. Outcomes include validated patient-reported measures and feasibility metrics such as enrollment, retention, and app usage.
Who should consider this trial
Good fit: Adults (18+) who speak English, have a hematologic malignancy, are scheduled to receive autologous FDA-approved CAR-T at MGH, and can provide informed consent are ideal candidates.
Not a fit: Patients who cannot consent due to cognitive impairment or uncontrolled mental illness, non-English speakers, those enrolled in another supportive care trial, or those receiving CAR-T elsewhere are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, the app could help patients better track symptoms, reduce distress, and improve quality of life during and after CAR-T therapy.
How similar studies have performed: Digital supportive care interventions in oncology have shown feasibility and modest benefits for symptom management and quality of life, but dedicated evidence in the CAR-T population is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Patrick C Johnson, MD
- Email: pcjohnson@mgh.harvard.edu
- Phone: 6177244000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.