THRIVE-CAR-T Digital App (THRIVE-CAR-T)

March 26, 2026 updated by: Patrick C. Johnson, MD

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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 behavior therapy, mindfulness, positive psychology), engagement, and health behavior change including gamification strategies, videos of patients who received CAR-T, and optional content.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: Through study completion, an average of 2 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: Through study completion, an average of 2 years
THRIVE-CAR-T will be deemed acceptable if at least 80% of patients report THRIVE-CAR-T is acceptable based upon a rating of "Somewhat comfortable" or "Very comfortable" on a 4 point Likert scale single question when asked about whether they feel comfortable with the intervention.
Through study completion, an average of 2 years
Quality of life
Time Frame: From enrollment until 90 days after CAR-T cell therapy
Quality of life will be assessed using the Functional Assessment of Cancer Therapy-General (FACT-G). The FACT-G is a 27-item measure consisting of four subscales assessing well-being across four domains (physical, functional, emotional, and social) during the preceding week. Scores range from 0 to 108, with higher scores indicating better QOL
From enrollment until 90 days after CAR-T cell therapy
Anxiety symptoms
Time Frame: From enrollment until 90 days after CAR-T cell therapy
Anxiety symptoms will be assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item measure with two separate subscales to evaluate symptoms of anxiety and depression. Scores on each subscale range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant anxiety or depression.
From enrollment until 90 days after CAR-T cell therapy
Depression symptoms
Time Frame: From enrollment until 90 days after CAR-T cell therapy
Depression symptoms will be assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item measure with two separate subscales to evaluate symptoms of anxiety and depression. Scores on each subscale range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant anxiety or depression
From enrollment until 90 days after CAR-T cell therapy
PTSD symptoms
Time Frame: From enrollment until 90 days after CAR-T cell therapy
PTSD symptoms will be assessed using the Post-traumatic Stress Disorder Checklist-Civilian Version, a17-item PTSD Checklist that evaluates the severity of PTSD symptoms. Scores range from 0-68. Higher scores on the PCL indicate worse PTSD symptoms, with a cutoff of 32 or greater denoting clinically significant PTSD symptoms
From enrollment until 90 days after CAR-T cell therapy

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-efficacy
Time Frame: From enrollment until 90 days after CAR-T cell therapy
Self-efficacy will be assessed using the Cancer Self-efficacy Scale (CASE), a commonly utilized measure to assess patients' confidence in managing the impact of their illness. Scores range from 12-48, with higher scores denoting better self-efficacy.
From enrollment until 90 days after CAR-T cell therapy
Coping
Time Frame: From enrollment until 90 days after CAR-T cell therapy
Coping will be assessed using the Measure of Current Status Part A (MOCS-A), a 13-item measure to assess the self-perceived status on several coping skills such as relaxation, cognitive restructuring, and assertive communication. Scores range from 0-52, wither scores denoting greater coping ability.
From enrollment until 90 days after CAR-T cell therapy
Knowledge about CAR-T cell therapy
Time Frame: From enrollment until 90 days after CAR-T cell therapy
Knowledge will be assessed with a Knowledge assessment, where patients will complete nine true/false questions and one multiple choice question to assess patients' knowledge regarding CAR T-cell therapy, with each question worth 1 point for a possible total of 10 points, as done in prior work. Scores range from 0-10, with higher scores denoting greater knowledge.
From enrollment until 90 days after CAR-T cell therapy
Usability of THRIVE-CAR-T
Time Frame: From enrollment until 30 days after CAR-T cell therapy
Usability of THRIVE-CAR-T will only be assessed in those randomized to THRIVE-CAR-T). We will use the system usability scale at day 30 to assess the usability of THRIVE-CAR-T. Scores range from 0-100, with higher scores denoting greater usability.
From enrollment until 30 days after CAR-T cell therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Patrick C. Johnson, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24-428

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Deidentified data will be made available upon email request to the principal investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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