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

Stiftung Swiss Tumor Institute

Status: Enrolling

Conditions: CAR T-Cell Therapy; Patient Reported Outcome Measures

Treatments: Device: Consilium CareTM

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05354973

KEK ZH: 2021-D0077

Details and patient eligibility

About

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.

Enrollment: 11 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed ICF
2. Patients > 18 years
3. Patients receiving CAR T cell treatment
4. Personal smartphone with iOS or Android system. The operating system must be updated to one of the two newest main versions.

Exclusion criteria

1. 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.
2. Patients with insufficient knowledge about the use of a smartphone.

Trial design

11 participants in 1 patient group

CAR T Cell Treatment

Treatment:

Device: Consilium CareTM