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The SMART CART Study: Health Information Technology

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ClinicalTrials.gov Identifier: NCT04051216
Recruitment Status : Enrolling by invitation
First Posted : August 9, 2019
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Brief Summary:
This study evaluates the feasibility of using two information technology tools in patients undergoing Chimeric Antigen Receptor T-cell (CART) therapy. 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.

Condition or disease Intervention/treatment Phase
Leukemia, Acute Leukemia, Lymphoblastic Behavioral: Education information system Other: Activity monitor Other: Interview Other: Survey Administration Other: Laboratory Biomarker Analysis Not Applicable

Detailed Description:

30 patients will be asked to participate in the wearable device portion of the study. 30 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 therapy, when they get discharged from the hospital and around 100 days after they receive their CART 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 CART therapy process.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The SMART CART Study: Health Information Technology
Actual Study Start Date : December 20, 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: Supportive Care
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.
Behavioral: Education information system
Participants will receive a mobile tablet as an educational intervention
Other Name: Roadmap information system

Other: Activity monitor
Participants will receive at least 1 of 4 activity monitoring devices

Other: Interview
Participants will be interviewed about their experience using the device(s)

Other: Survey Administration
Participants will receive surveys

Other: Laboratory Biomarker Analysis
Correlative studies




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. 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 ]
    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.

  4. 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 ]
    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.

  5. Presence of care process redesign associated with the Roadmap information system and wearable monitoring devices. [ Time Frame: Up to day 100 post-CART ]
    Measured qualitatively by semi-structured qualitative interviews.

  6. Quality of care process redesign associated with the Roadmap information system and wearable monitoring devices. [ Time Frame: Up to day 100 post-CART ]
    Measured qualitatively by semi-structured qualitative interviews.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION:

  • Caregiver (age 18 years or older) of any patient eligible to undergo CART therapy and any patient (age 5 years or older) eligible to undergo CART therapy 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 CART therapy 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 5 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. 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. Patients (18 years or older) will be asked to complete surveys. The patient will also be provided with their own non-invasive, wearable activity monitoring device(s) that will track activity and rest levels. Patients 5-9 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 and wearable devices.
  • 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

EXCLUSION:

  • Not willing and able to provide informed consent.
  • Not willing to comply with study procedures and reporting requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04051216


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Bristol-Myers Squibb
Investigators
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Principal Investigator: Sung Won Choi, MD, MS University of Michigan

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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT04051216     History of Changes
Other Study ID Numbers: UMCC 2016.051
HUM00115179 ( Other Identifier: University of Michigan Rogel Cancer Center )
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Michigan Rogel Cancer Center:
caregivers
health information technology
patient-centered care
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases