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CAR T-cell Therapy

Health Information Technology for Cancer Management

N/A
Waitlist Available
Led By Sung Won Choi, MD, MS
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 100 post-cart
Awards & highlights

Study Summary

This trial looks at whether using an iPad app and a wearable activity tracker can help manage side effects in cancer patients undergoing treatment that can cause severe flu-like symptoms.

Who is the study for?
This trial is for caregivers and patients dealing with leukemia or lymphoma who are undergoing treatments that can cause severe immune reactions, like CART therapy. Caregivers must be over 18, while patients can be as young as 3 years old. Participants need to speak English fluently and agree to follow the study's procedures.Check my eligibility
What is being tested?
The study tests two health information technology tools: an iPad app called BMT Roadmap for tracking health data, and a wearable device monitoring physical activity. These tools aim to help patients and caregivers take a more active role in managing healthcare during intense treatments.See study design
What are the potential side effects?
Since this trial focuses on information technology tools rather than medications, traditional side effects aren't expected. However, participants may experience discomfort or inconvenience from wearing the activity monitor or using the iPad application.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 100 post-cart
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 100 post-cart for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
Care providers' satisfaction with the Roadmap information system and non-invasive, wearable activity monitoring device health IT tools for patients and their families/caregivers.
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.
Percentage of patients from whom longitudinal samples of blood, urine and stool are collected, for correlative studies.
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Supportive CareExperimental Treatment5 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Education information system
2015
N/A
~60

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
292 Previous Clinical Trials
23,917 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,336 Total Patients Enrolled
Sung Won Choi, MD, MSPrincipal InvestigatorUniversity of Michigan
4 Previous Clinical Trials
3,213 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies for potential trial participants?

"According to data published on clinicaltrials.gov, this trial is not currently accepting candidates. The research was initially posted in December 2017 and the most recent updates were made in February 2022. Although no further recruitment is taking place at present, there are 1483 other medical trials actively recruiting patients right now."

Answered by AI
~28 spots leftby Mar 2025