Recruiting

THRIVE-CAR-T

Sponsor:

Patrick C. Johnson, MD

Code:

NCT06665295

Conditions

CAR T-Cell Therapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

THRIVE-CAR-T

Study Details

Brief 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.

Conditions

CAR T-Cell Therapy

Study ID

NCT06665295

Start date

Oct 17, 2024

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Usual Care

Usual care at our institution involves a teaching visit with a nurse navigator and written handouts.

experimental: THRIVE-CAR-T plus usual care

Patients receiving the THRIVE-CAR-T intervention will receive usual care and will use the THRIVE-CAR-T digital application on an iPad when planned to receive CAR-T.

Interventions

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.

Primary outcome measure

  • Feasibility [ Time Frame: Through study completion, an average of 2 years ]

Central Contacts and Locations

Central contacts

Patrick C Johnson, MD

6177244000pcjohnson@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Patrick C Johnson, MD

6177244000pcjohnson@mgh.harvard.edu

More Information

Sponsor

Patrick C. Johnson, MD

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Keywords

  • car-t cell therapy
  • digital application
  • mobile application
  • randomized controlled trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Patrick C. Johnson, MD on 2026-04-01.