Hematologic MalignanciesPhase 3NCT07186192
Digital Health Intervention for Self-Management and Telemonitoring in Chimeric Antigen Receptor (CAR-T) Therapy
A Phase 3 study testing Educational Intervention, Health Telemonitoring and Questionnaire Administration in people with Hematologic Malignancies, run by City of Hope Medical Center at 1 site in United States.
Trial summary
The overall purpose of this randomized control trial (RCT) is to determine the clinical effect of a multilevel, RPM-enhanced intervention during and after completion of outpatient CAR-T therapy in 190 patients and their family caregivers (FCGs). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- Educational Intervention, Health Telemonitoring and Questionnaire Administration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2026to 29 Mar 2029
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient Inclusion Criteria Informed Consent and Willingness to Participate
- Documented informed consent of the participant and/or legally authorized representative Age and Language Criteria
- Age ≥ 18 years old at the time of enrollment
- Ability to read and understand English or Spanish for Questionnaires Nature of Illness and Treatment Related Criteria
- Relapsed or refractory hematologic malignancy
- Scheduled to receive outpatient standard of care (SOC) CAR-T therapy
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- Has a FCG committed to living with the patient for the duration of the study
- Family Caregiver Inclusion Criteria Informed Consent and Willingness to Participate
- Documented informed consent of the participant and/or legally authorized representative Age and Language Criteria
- Age ≥ 18 years old at the time of enrollment
- Ability to read and understand English or Spanish for Questionnaires Nature of Illness and Treatment Related Criteria
- Family member or friend identified by the patient and defined as a person who knows the patient well and is involved in the patient's medical care
- Exclusion Criteria 1. An employee who is under the direct/indirect supervision of the PI/ a co-investigator/ the study manager 2. A direct study team member
- -
Who cannot join
None listed.
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
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Digital Health Intervention for Self-Management and Telemonitoring in Chimeric Antigen Receptor-T Cell (CAR-T)Therapy
The overall purpose of this randomized control trial (RCT) is to determine the clinical effect of a multilevel, RPM-enhanced intervention during and after completion of outpatient CAR-T therapy in 190 patients and their family caregivers (FCGs).
- Conditions
- Hematologic Malignancies
- Being tested
- Educational Intervention, Health Telemonitoring, Questionnaire Administration, Best Practice
- Keywords
- CAR-T, Digital health intervention
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Patients and family caregivers that are randomized into the intervetnion arm (Digital health intervention) will receive a 90 day nurse-drive, digital health intervention. Participate in self-management coaching sessions
Health TelemonitoringProcedure or surgery
Wear a FitBit device and use a mobile app for nurse tracking
Questionnaire AdministrationOther
Ancillary studies
Best PracticeOther
Also called best practice, standard of care, standard of care, standard of care, standard therapy
Given usual care
| Study group | Role | What they receive |
|---|---|---|
| Arm A - self-management coaching, telemonitoring | Experimental | Patients and their FCGs participate in self-management coaching sessions over 60 minutes each prior to CAR-T infusion and at approximately days 21, 42, and 70 post-CAR-T infusion. Beginning 15-20 days post CAR-T infusion, participants wear a FitBit device and use a mobile app QD three times per week for 90 days for tracking by nurses of daily steps, temperature, blood pressure, oxygen level, weight, and distress levels. Receives: Other: Educational Intervention; Procedure: Health Telemonitoring; Other: Questionnaire Administration |
| Arm B - Standard of Care Arm ( Enhanced usual care) | Active comparator | Patients and their FCGs receive usual care, including standard print educational materials on study. Receives: Other: Questionnaire Administration; Other: Best Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
MD Anderson Symptom Inventory CAR-T module (MDASI-CAR - patient)
This is validated measure of 22 CAR-T specific symptoms and other cancer-related symptoms. Symptom severity is rated on a 10-point scale: 1-3 mild, 4-6 moderate, ≥7 severe. Patients also rate how much their symptoms interfere with 6 functional domains: walking, activity, working/housework, relationships, enjoyment of life, and mood. A change in 1.2 points is clinically meaningful and cutoffs for clinical deficits have been defined. Cronbach's α reliability: 82-0.94.
Measured: Baseline, Day 15 - Day 20 post-CAR-T, Day 30, Day 60, and Day 90
Distress Thermometer (DT - FCG)
This is an efficient, low-subject-burden measure to evaluate psychological distress over the past week, based on a scale of 0 (no distress) to 10 (extremely distressed). A cut-off of 3/10 indicates a need for intervention, with acceptable sensitivity (94.1%) and specificity (71.2%) compared to the longer Hospital Anxiety and Depression Scale (HADS). The DT has been validated in FCGs, and we chose it for its brevity, accuracy ease of use in remote monitoring, and validity in FCGs.
Measured: Baseline, Day 15 - Day 20 post-CAR-T, Day 30, Day 60, and Day 90
Secondary outcomes (2)
Montgomery Borgatta Caregiver Burden Scale (FCG)
This is a 14-item tool designed to measure the impact of caregiving on three dimensions of burden: objective, subjective demand, and subjective stress. Internal consistency for the three dimensions ranges from 0.81-0.90. The ordinal scale ranges from 1-5 (a lot less to a lot more). The following cutoff scores are interpreted as high burden: 1) a score of ≥23 for objective burden, 2) a score of ≥15 for subjective demand, and 3) a score of ≥13.5 for subjective stress.
Measured: Baseline, Day 30, Day 60, and Day 90
Functional Assessment of Cancer Therapy-General (FACTG - patient)
This is a cancer-specific version of the FACIT (Functional Assessment of Chronic Illness Therapy) Measurement System. It contains a 27-item compilation of general questions divided into four QoL domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. For each item, the respondent indicates on a 5-point Likert scale (0=not at all; 4=very much) how true each statement is for him/her during the past 7d. The FACT-G yields a total score for overall QoL as well as subscale scores. Internal consistency and reliability measures revealed a Cronbach's α of 0.89 for the total FACT-G, and a range of 0.70-0.82 for the four subscales.
Measured: Baseline, Day 30, Day 60, and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start14 Jan 2026
- Primary completion29 Mar 2029 (estimated)
- Study completion29 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Virginia Sun, PhD, RN, Principal investigator, City of Hope Medical CenterSaro Armenian, DO, MPH, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186192
- Sponsor's protocol ID
- 25328
- Status last verified
- Aug 2026
- First submitted
- 7 Sep 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Health Intervention for Self-Management and Telemonitoring in Chimeric Antigen Receptor-T Cell (CAR-T)Therapy
- ClinicalTrials.gov ID
- NCT07186192
- Acronym / sponsor ID
- 25328
- Conditions
- Hematologic Malignancies
- Keywords
- CAR-T, Digital health intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 29 Mar 2029 (estimated)
- Study completion
- 29 Mar 2029 (estimated)
- First posted
- 22 Sep 2025 (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 overall purpose of this randomized control trial (RCT) is to determine the clinical effect of a multilevel, RPM-enhanced intervention during and after completion of outpatient CAR-T therapy in 190 patients and their family caregivers (FCGs).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A - self-management coaching, telemonitoring | Experimental | Other: Educational Intervention, Procedure: Health Telemonitoring, Other: Questionnaire AdministrationPatients and their FCGs participate in self-management coaching sessions over 60 minutes each prior to CAR-T infusion and at approximately days 21, 42, and 70 post-CAR-T infusion. Beginning 15-20 days post CAR-T infusion, participants wear a FitBit device and use a mobile app QD three times per week for 90 days for tracking by nurses of daily steps, temperature, blood pressure, oxygen level, weight, and distress levels. |
| Arm B - Standard of Care Arm ( Enhanced usual care) | Active comparator | Other: Questionnaire Administration, Other: Best PracticePatients and their FCGs receive usual care, including standard print educational materials on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient Inclusion Criteria Informed Consent and Willingness to Participate
- Documented informed consent of the participant and/or legally authorized representative Age and Language Criteria
- Age ≥ 18 years old at the time of enrollment
- Ability to read and understand English or Spanish for Questionnaires Nature of Illness and Treatment Related Criteria
- Relapsed or refractory hematologic malignancy
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalPatients and family caregivers that are randomized into the intervetnion arm (Digital health intervention) will receive a 90 day nurse-drive, digital health intervention. Participate in self-management coaching sessions | Other | Arm A - self-management coaching, telemonitoring |
| Health TelemonitoringWear a FitBit device and use a mobile app for nurse tracking | Procedure or surgery | Arm A - self-management coaching, telemonitoring |
| Questionnaire AdministrationAncillary studies | Other | Arm A - self-management coaching, telemonitoring, Arm B - Standard of Care Arm ( Enhanced usual care) |
| Best PracticeAlso: best practice, standard of care, standard of care, standard of care, standard therapyGiven usual care | Other | Arm B - Standard of Care Arm ( Enhanced usual care) |
Primary outcome
MD Anderson Symptom Inventory CAR-T module (MDASI-CAR - patient)
Time frame: Baseline, Day 15 - Day 20 post-CAR-T, Day 30, Day 60, and Day 90
This is validated measure of 22 CAR-T specific symptoms and other cancer-related symptoms. Symptom severity is rated on a 10-point scale: 1-3 mild, 4-6 moderate, ≥7 severe. Patients also rate how much their symptoms interfere with 6 functional domains: walking, activity, working/housework, relationships, enjoyment of life, and mood. A change in 1.2 points is clinically meaningful and cutoffs for clinical deficits have been defined. Cronbach's α reliability: 82-0.94.
Distress Thermometer (DT - FCG)
Time frame: Baseline, Day 15 - Day 20 post-CAR-T, Day 30, Day 60, and Day 90
This is an efficient, low-subject-burden measure to evaluate psychological distress over the past week, based on a scale of 0 (no distress) to 10 (extremely distressed). A cut-off of 3/10 indicates a need for intervention, with acceptable sensitivity (94.1%) and specificity (71.2%) compared to the longer Hospital Anxiety and Depression Scale (HADS). The DT has been validated in FCGs, and we chose it for its brevity, accuracy ease of use in remote monitoring, and validity in FCGs.
2 secondary outcomes
Montgomery Borgatta Caregiver Burden Scale (FCG)
Time frame: Baseline, Day 30, Day 60, and Day 90
Functional Assessment of Cancer Therapy-General (FACTG - patient)
Time frame: Baseline, Day 30, Day 60, and Day 90
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 28 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Virginia Sun, PhD, RN principal investigator
City of Hope Medical Center
Saro Armenian, DO, MPH principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Educational Intervention, Health Telemonitoring and Questionnaire Administration in people with Hematologic Malignancies, run by City of Hope Medical Center 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 14 inclusion and 0 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 28 Aug 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Virginia Sun, PhD, RN (626-218-3122, vsun@coh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MD Anderson Symptom Inventory CAR-T module (MDASI-CAR - patient) (time frame: Baseline, Day 15 - Day 20 post-CAR-T, Day 30, Day 60, and Day 90). The study lists 2 primary outcomes in all. 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 28 Aug 2026.