ePRO for the Timely Detection of Side Effects in Cancer Patients Undergoing CAR T Immunotherapy: Feasibility Study (CARTePRO)

Stiftung Swiss Tumor Institute1 site in 1 country11 target enrollmentMarch 21, 2022

ConditionsPatient Reported Outcome Measures CAR T-Cell Therapy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Patient Reported Outcome Measures
Sponsor: Stiftung Swiss Tumor Institute
Enrollment: 11
Locations: 1
Primary Endpoint: Response time
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed as a feasibility study implementing electronic Patient Reported Outcomes (ePRO) in CAR T treatment for hematological malignancies, in order to describe AE reporting. ePRO assessments will be explored for their feasibility to engage in monitoring and management of CAR T-related toxicities as well as using these digital ePRO tools may improve both, its safety and accessibility.

Registry

clinicaltrials.gov

Start Date

March 21, 2022

End Date

April 30, 2025

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Stiftung Swiss Tumor Institute

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients \> 18 years
•Patients receiving CAR T cell treatment
•Personal smartphone with iOS or Android system. The operating system must be updated to one of the two newest main versions.

Exclusion Criteria

•Patients, whose compliance to the studies' protocol, e.g. due to mental health problems, physical problems, or the private life situation, can be justifiably doubted.
•Patients with insufficient knowledge about the use of a smartphone.

Outcomes

Primary Outcomes

Response time

Time Frame: 84 day +/- 6 days

Response time in seconds obtained during trail-making test (ePRO) according to daily administration via consilium careTM app, as a potential indicator for ICANS and other CAR T cell therapy-related adverse events.

Secondary Outcomes

Occurrence and type of therapy-associated unplanned consultations(84 day +/- 6 days)
Well-being(84 day +/- 6 days)
Occurrence of CRS-related adverse events (ePRO)(84 day +/- 6 days)
Adherence(84 day +/- 6 days)
Number and severity of adverse events (AE) according to the CTCAE(84 day +/- 6 days)