THRIVE-CAR-T Digital App

NCT06665295 | Recruiting

• 1 other identifier: 24-428
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Feasibility

  Feasibility is defined based on the rate of patient enrollment. THRIVE-CAR-T will be deemed feasible if rates of enrollment are \>= 60%, and among those enrolled and randomized to THRIVE-CAR-T, 60% complete 3 out of 5 modules. For patients who either die prior to the end of the intervention or are admitted to the intensive care unit (ICU), the latter definition of feasibility will be completion of 60% of expected modules at the time of clinical deterioration.

  Through study completion, an average of 2 years

Secondary Outcomes (5)

• Acceptability

  Through study completion, an average of 2 years

• Quality of life

  From enrollment until 90 days after CAR-T cell therapy

• Anxiety symptoms

  From enrollment until 90 days after CAR-T cell therapy

• Depression symptoms

  From enrollment until 90 days after CAR-T cell therapy

• PTSD symptoms

  From enrollment until 90 days after CAR-T cell therapy

Other Outcomes (4)

• Self-efficacy

  From enrollment until 90 days after CAR-T cell therapy

• Coping

  From enrollment until 90 days after CAR-T cell therapy

• Knowledge about CAR-T cell therapy

  From enrollment until 90 days after CAR-T cell therapy

Study Arms (2)

Usual Care

NO INTERVENTION

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

THRIVE-CAR-T plus usual care

EXPERIMENTAL

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.

Behavioral: THRIVE-CAR-T

Interventions

THRIVE-CAR-T BEHAVIORAL

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.

THRIVE-CAR-T plus usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Ability to understand English
• Diagnosis of a hematologic malignancy
• Receiving autologous CAR-T at MGH with an FDA approved cellular therapy product

You may not qualify if:

• Impaired cognition or uncontrolled mental illness that prohibits the ability to provide informed consent based on the oncology clinician assessment
• Already participating in another supportive care clinical trial

Sponsors & Collaborators

• Patrick C. Johnson, MD: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Central Study Contacts

Patrick C Johnson, MD

CONTACT

6177244000; pcjohnson@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 30, 2024
• Study Start: October 17, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)