CAR T-Cell TherapyTHRIVE-CAR-TNCT06665295
THRIVE-CAR-T Digital App
A study testing THRIVE-CAR-T in people with CAR T-Cell Therapy, run by Patrick C. Johnson, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CAR T-Cell Therapy
- What is being tested?
- THRIVE-CAR-T
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Patrick C Johnson, MD, 6177244000, pcjohnson@mgh.harvard.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- CAR T-Cell Therapy
- Being tested
- THRIVE-CAR-T
- Keywords
- car-t cell therapy, digital application, mobile application, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THRIVE-CAR-TBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: THRIVE-CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 2 years
Secondary outcomes (5)
Acceptability
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.
Measured: Through study completion, an average of 2 years
Quality of life
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
Measured: From enrollment until 90 days after CAR-T cell therapy
Anxiety symptoms
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.
Measured: From enrollment until 90 days after CAR-T cell therapy
Depression symptoms
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
Measured: From enrollment until 90 days after CAR-T cell therapy
PTSD symptoms
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
Measured: From enrollment until 90 days after CAR-T cell therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start17 Oct 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAR T-Cell TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Patrick C. Johnson, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Patrick C. Johnson, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665295
- Sponsor's protocol ID
- 24-428
- Acronym
- THRIVE-CAR-T
- Status last verified
- Mar 2026
- First submitted
- 24 Oct 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified data will be made available upon email request to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Supportive Care Digital Application (THRIVE-CAR-T) for Patients Receiving CAR-T Cell Therapy
- ClinicalTrials.gov ID
- NCT06665295
- Acronym / sponsor ID
- THRIVE-CAR-T / 24-428
- Conditions
- CAR T-Cell Therapy
- Keywords
- car-t cell therapy, digital application, mobile application, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Patrick C. Johnson, MDUniversity, hospital or other
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: THRIVE-CAR-TPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THRIVE-CAR-TThe 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. | Behavioural | THRIVE-CAR-T plus usual care |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No. Deidentified data will be made available upon email request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THRIVE-CAR-T in people with CAR T-Cell Therapy, run by Patrick C. Johnson, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick C Johnson, MD (6177244000, pcjohnson@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.