THRIVE-CAR-T Digital App
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: THRIVE-CAR-T.
- Who it may be relevant to
- Registry conditions: CAR T-Cell Therapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Controlled Trial of a Supportive Care Digital Application (THRIVE-CAR-T) for Patients Receiving CAR-T Cell Therapy
Overview
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.
Detailed 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.
Interventions
- Behavioral 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 beha
Primary outcome measures
- Feasibility [Time frame: Through study completion, an average of 2 years]
Secondary outcome measures (5)
- Acceptability [Time frame: Through study completion, an average of 2 years]
- Quality of life [Time frame: From enrollment until 90 days after CAR-T cell therapy]
- Anxiety symptoms [Time frame: From enrollment until 90 days after CAR-T cell therapy]
- Depression symptoms [Time frame: From enrollment until 90 days after CAR-T cell therapy]
- PTSD symptoms [Time frame: From enrollment until 90 days after CAR-T cell therapy]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT06665295 · 24-428