RecruitingNot ApplicableNCT06665295

THRIVE-CAR-T Digital App

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


Sponsor

Patrick C. Johnson, MD

Enrollment

100 participants

Start Date

Oct 17, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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

Exclusion Criteria2

  • 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

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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.


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT06665295


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