The SMART CART Study: Health Information Technology

NCT04051216 | Completed

• 2 other identifiers: UMCC 2016.051HUM00115179
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Leukemia, Acute; Leukemia, Lymphoblastic

Keywords

caregivers; health information technology; patient-centered care

Outcome Measures

Primary Outcomes (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.

  To test the feasibility of implementing the system in the pediatric CART population. This aim will be measured quantitatively by the log-use data.

  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.

  Up to day 100 post-CART

• Percentage of patients from whom longitudinal samples of blood, urine and stool are collected, for correlative studies.

  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.

  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.

  Up to day 100 post-CART

• Presence of care process redesign associated with the Roadmap information system and wearable monitoring devices.

  Up to day 100 post-CART

Study Arms (1)

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.

Behavioral: Education information system; Other: Activity monitor; Other: Interview; Other: Survey Administration; Other: Laboratory Biomarker Analysis

Interventions

Education information system BEHAVIORAL

Participants will receive a mobile tablet as an educational intervention

Also known as: Roadmap information system

Supportive Care

Activity monitor OTHER

Participants will receive at least 1 of 4 activity monitoring devices

Supportive Care

Interview OTHER

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

Supportive Care

Survey Administration OTHER

Participants will receive surveys

Supportive Care

Laboratory Biomarker Analysis OTHER

Correlative studies

Supportive Care

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Fitness Trackers; Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sung Won Choi, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: August 9, 2019
• Study Start: December 20, 2017
• Primary Completion: August 25, 2023
• Study Completion: November 23, 2023
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

US (1)