Leukemia, AcuteNCT04051216
The SMART CART Study: Health Information Technology
A study testing Education information system, Activity monitor and Interview in people with Leukemia, Acute and Leukemia, Lymphoblastic, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This study evaluates the feasibility of using two information technology tools in patients undergoing Chimeric Antigen Receptor T-cell (CART) therapy and other Cytokine Release Syndrome (CRS)-eliciting treatments such as CD123 BITE. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Leukemia, Acute, Leukemia, Lymphoblastic
- What is being tested?
- Education information system, Activity monitor and Interview
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2017to 23 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Caregiver (age 18 years or older) of any patient eligible to undergo therapy in BMT or hematology/oncology that elicits CRS including CART and CD123 BITE and any patient (age 3 years or older) eligible to undergo therapy in BMT or hematology/oncology that elicits CRS including CART and CD123 BITE will be recruited during the "Pre-CART Workup" stage in the outpatient setting.
- CAREGIVER PARTICIPANTS: Caregiver (age 18 years or older) of a patient who will be hospitalized to receive therapy which elicits CRS in the University of Michigan Mott Children's Hospital Adult or Pediatric BMT Units. The age range of patients typically transplanted in the Pediatric BMT unit is 0-25 years, while the Adult BMT unit transplants those older than 25. Caregivers with children (patients) who are younger than 3 years of age may be eligible to participate even though their children are too young to assent or participate themselves.
- PATIENT PARTICIPANTS: Patient (age 10 years or older) who will be hospitalized to receive or after receiving CART therapy will be given the opportunity to assent/consent and participate in the study. With his/her permission, the patient will also be provided with their own iPad® Roadmap information system to use. Qualitative interviews will be conducted in patients (age 10 years or older) with their assent/consent along with neurocognitive testing. Patients (age 10-17.9 years) will be asked to complete surveys that have been validated in this age group and that offer insight into the usefulness of the Roadmap along with neurocognitive testing. Patients (18 years or older) will be asked to complete surveys along with neurocognitive testing. The patient will also be provided with their own non-invasive, wearable activity monitoring device(s) that will track activity and rest levels. Patients 3-9 years old will be enrolled with parental consent but will not be approached for assent. These patients will not be eligible to participate in the survey or interview portions of the study, however, they will be eligible for sample collection, wearable devices and neurocognitive testing.
- Ability to speak and read proficiently in English (the study's instruments have not been translated and validated in languages other than English)
- Willing and able to provide informed consent
- Willing to comply with study procedures and reporting requirements
Who cannot join
- Not willing and able to provide informed consent.
- Not willing to comply with study procedures and reporting requirements.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the feasibility of using two information technology tools in patients undergoing Chimeric Antigen Receptor T-cell (CART) therapy and other Cytokine Release Syndrome (CRS)-eliciting treatments such as CD123 BITE. The first is an Apple iPad® application called the BMT Roadmap, which shows information about the participant's health. The second is a wearable activity monitoring device. Health information technology tools such as Roadmap system and the activity monitoring device may enable caregivers and patients to become more active participants in their healthcare.
Read the detailed description
100 patients will be asked to participate in the wearable device portion of the study. 100 caregivers will be asked to participate in the Roadmap (iPad) portion of the study.
Each caregiver will be provided with an iPad to use the BMT Roadmap system. Patients and/or caregivers are free to use this tool as much as they would like on their own time while in the hospital. The hospital care team will collect the iPad when the patient is discharged and ready to go home. Patients and caregivers will also be asked to take three surveys that will ask about their feelings and thoughts about the Roadmap application. The surveys will be completed when patients are admitted for their CART or other CRS-eliciting therapy, when they get discharged from the hospital and around 100 days after they receive their therapy.
In addition to the use of the BMT Roadmap, this study will include around 7-10 interviews about participants' opinions on the two tools and their experience in the therapy process.
- Conditions
- Leukemia, Acute, Leukemia, Lymphoblastic
- Being tested
- Education information system, Activity monitor, Interview, Survey Administration, Laboratory Biomarker Analysis
- Keywords
- caregivers, health information technology, patient-centered care
- Medical subject headings
- Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education information systemBehavioural
Also called Roadmap information system
Participants will receive a mobile tablet as an educational intervention
Activity monitorOther
Participants will receive at least 1 of 4 activity monitoring devices
InterviewOther
Participants will be interviewed about their experience using the device(s)
Survey AdministrationOther
Participants will receive surveys
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care | Experimental | Caregivers receive the Roadmap information system loaded on an Apple iPad® for use during the inpatient hospitalization of CART therapy. The Roadmap information system consists of 5 modules personalized to the CART patient: laboratory studies, medications, clinical trial enrollment, healthcare providers, and criteria for discharge. Patients wear an activity monitoring device on days 0-100. Patients wear the device as long as they can each day to monitor physical activity level, sleep/wake patterns, skin temperature, heart rate and respiratory rate. Receives: Behavioral: Education information system; Other: Activity monitor; Other: Interview; Other: Survey Administration; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of caregivers that log onto the BMT Roadmap at least once per day for a minimum of 4 of the 7 days of the week while the patient is in the hospital.
To test the feasibility of implementing the system in the pediatric CART population. This aim will be measured quantitatively by the log-use data.
Measured: Duration of hospital admission, up to ~6 weeks
Secondary outcomes (6)
Percentage of patients who are able to wear the activity monitoring device(s) approximately 12 hours of the day.
To test the feasibility of implementing a non-invasive, wearable activity monitoring device in the pediatric CART population. This aim will be measured quantitatively by the log-use data.
Measured: Up to day 100 post-CART
Percentage of patients from whom longitudinal samples of blood, urine and stool are collected, for correlative studies.
Feasibility of collecting longitudinal samples of blood, urine and stool from study population. Samples will be used to perform an exploratory analysis of the relationship between these biomarkers and clinical status, Roadmap and wearable device information.
Measured: Up to day 100 post-CART
Caregiver activation/participation compared to reference population to measure the impact of Roadmap information system and wearable monitoring device using survey instrument scores of Parent-Patient Activation Measure (P-PAM) as a composite measure.
Descriptive statistics will be calculated for each Patient Activation Measure (PAM) score and stratified into the appropriate level of activation. Results will be compared with a published sample. Univariate analyses will be performed to assess associations between PAM and demographic, social, and environmental characteristics of the parent (type of insurance, marital status, number of children in household), disease-related characteristics of the patients (age, disease, disease status at CART), satisfaction (Press Ganey, Usefulness), caregiver burden (CQOLC), mood (POMS), anxiety (STAI), stress (Impact of Event Scale-Revised), miscarried helping (HHI), and experiential avoidance (PAAQ). Pearson's correlation (and other suitable measures of association for categorical variables) will be used to determine the nature and significance of association between each variable and Parent-PAM scores. This analysis will not be powered to detect any statistically meaningful differences.
Measured: Up to day 100 post-CART
Care providers' satisfaction with the Roadmap information system and non-invasive, wearable activity monitoring device health IT tools for patients and their families/caregivers.
Qualitative interviews of BMT healthcare providers (physicians, nurses, advanced practitioners, social workers, psychologist, nutritionist, and pharmacologist). This is information gathering only. There is no reference population for this.
Measured: Up to day 100 post-CART
Presence of care process redesign associated with the Roadmap information system and wearable monitoring devices.
Measured qualitatively by semi-structured qualitative interviews.
Measured: Up to day 100 post-CART
Quality of care process redesign associated with the Roadmap information system and wearable monitoring devices.
Measured qualitatively by semi-structured qualitative interviews.
Measured: Up to day 100 post-CART
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start20 Dec 2017
- Primary completion25 Aug 2023
- Study completion23 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, AcuteStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Sung Won Choi, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051216
- Sponsor's protocol ID
- UMCC 2016.051
- Other IDs
- HUM00115179
- Status last verified
- Mar 2024
- First submitted
- 25 Jul 2019
- Last updated
- 22 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SMART CART Study: Health Information Technology
- ClinicalTrials.gov ID
- NCT04051216
- Acronym / sponsor ID
- UMCC 2016.051
- Conditions
- Leukemia, Acute, Leukemia, Lymphoblastic
- Keywords
- caregivers, health information technology, patient-centered care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 23 Nov 2023 (actual)
- First posted
- 9 Aug 2019 (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.
This study evaluates the feasibility of using two information technology tools in patients undergoing Chimeric Antigen Receptor T-cell (CART) therapy and other Cytokine Release Syndrome (CRS)-eliciting treatments such as CD123 BITE. The first is an Apple iPad® application called the BMT Roadmap, which shows information about the participant's health. The second is a wearable activity monitoring device. Health information technology tools such as Roadmap system and the activity monitoring device may enable caregivers and patients to become more active participants in their healthcare.
Detailed description
100 patients will be asked to participate in the wearable device portion of the study. 100 caregivers will be asked to participate in the Roadmap (iPad) portion of the study.
Each caregiver will be provided with an iPad to use the BMT Roadmap system. Patients and/or caregivers are free to use this tool as much as they would like on their own time while in the hospital. The hospital care team will collect the iPad when the patient is discharged and ready to go home. Patients and caregivers will also be asked to take three surveys that will ask about their feelings and thoughts about the Roadmap application. The surveys will be completed when patients are admitted for their CART or other CRS-eliciting therapy, when they get discharged from the hospital and around 100 days after they receive their therapy.
In addition to the use of the BMT Roadmap, this study will include around 7-10 interviews about participants' opinions on the two tools and their experience in the therapy process.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care | Experimental | Behavioral: Education information system, Other: Activity monitor, Other: Interview, Other: Survey Administration, Other: Laboratory Biomarker AnalysisCaregivers receive the Roadmap information system loaded on an Apple iPad® for use during the inpatient hospitalization of CART therapy. The Roadmap information system consists of 5 modules personalized to the CART patient: laboratory studies, medications, clinical trial enrollment, healthcare providers, and criteria for discharge. Patients wear an activity monitoring device on days 0-100. Patients wear the device as long as they can each day to monitor physical activity level, sleep/wake patterns, skin temperature, heart rate and respiratory rate. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Caregiver (age 18 years or older) of any patient eligible to undergo therapy in BMT or hematology/oncology that elicits CRS including CART and CD123 BITE and any patient (age 3 years or older) eligible to undergo therapy in BMT or hematology/oncology that elicits CRS including CART and CD123 BITE will be recruited during the "Pre-CART Workup" stage in the outpatient setting.
- CAREGIVER PARTICIPANTS: Caregiver (age 18 years or older) of a patient who will be hospitalized to receive therapy which elicits CRS in the University of Michigan Mott Children's Hospital Adult or Pediatric BMT Units. The age range of patients typically transplanted in the Pediatric BMT unit is 0-25 years, while the Adult BMT unit transplants those older than 25. Caregivers with children (patients) who are younger than 3 years of age may be eligible to participate even though their children are too young to assent or participate themselves.
- PATIENT PARTICIPANTS: Patient (age 10 years or older) who will be hospitalized to receive or after receiving CART therapy will be given the opportunity to assent/consent and participate in the study. With his/her permission, the patient will also be provided with their own iPad® Roadmap information system to use. Qualitative interviews will be conducted in patients (age 10 years or older) with their assent/consent along with neurocognitive testing. Patients (age 10-17.9 years) will be asked to complete surveys that have been validated in this age group and that offer insight into the usefulness of the Roadmap along with neurocognitive testing. Patients (18 years or older) will be asked to complete surveys along with neurocognitive testing. The patient will also be provided with their own non-invasive, wearable activity monitoring device(s) that will track activity and rest levels. Patients 3-9 years old will be enrolled with parental consent but will not be approached for assent. These patients will not be eligible to participate in the survey or interview portions of the study, however, they will be eligible for sample collection, wearable devices and neurocognitive testing.
- Ability to speak and read proficiently in English (the study's instruments have not been translated and validated in languages other than English)
- Willing and able to provide informed consent
Key exclusion criteria (2 listed)
- Not willing and able to provide informed consent.
- Not willing to comply with study procedures and reporting requirements.
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 |
|---|---|---|
| Education information systemAlso: Roadmap information systemParticipants will receive a mobile tablet as an educational intervention | Behavioural | Supportive Care |
| Activity monitorParticipants will receive at least 1 of 4 activity monitoring devices | Other | Supportive Care |
| InterviewParticipants will be interviewed about their experience using the device(s) | Other | Supportive Care |
| Survey AdministrationParticipants will receive surveys | Other | Supportive Care |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Supportive Care |
Primary outcome
Percentage of caregivers that log onto the BMT Roadmap at least once per day for a minimum of 4 of the 7 days of the week while the patient is in the hospital.
Time frame: Duration of hospital admission, up to ~6 weeks
To test the feasibility of implementing the system in the pediatric CART population. This aim will be measured quantitatively by the log-use data.
6 secondary outcomes
Percentage of patients who are able to wear the activity monitoring device(s) approximately 12 hours of the day.
Time frame: Up to day 100 post-CART
Percentage of patients from whom longitudinal samples of blood, urine and stool are collected, for correlative studies.
Time frame: Up to day 100 post-CART
Caregiver activation/participation compared to reference population to measure the impact of Roadmap information system and wearable monitoring device using survey instrument scores of Parent-Patient Activation Measure (P-PAM) as a composite measure.
Time frame: Up to day 100 post-CART
Care providers' satisfaction with the Roadmap information system and non-invasive, wearable activity monitoring device health IT tools for patients and their families/caregivers.
Time frame: Up to day 100 post-CART
Presence of care process redesign associated with the Roadmap information system and wearable monitoring devices.
Time frame: Up to day 100 post-CART
Quality of care process redesign associated with the Roadmap information system and wearable monitoring devices.
Time frame: Up to day 100 post-CART
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
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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. This study is not recruiting at the moment.
Sung Won Choi, MD, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education information system, Activity monitor and Interview in people with Leukemia, Acute and Leukemia, Lymphoblastic, run by University of Michigan Rogel Cancer 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 6 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: finished, as of the sponsor's last update on 22 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of caregivers that log onto the BMT Roadmap at least once per day for a minimum of 4 of the 7 days of the week while the patient is in the hospital. (time frame: Duration of hospital admission, up to ~6 weeks). 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 22 Mar 2024.