Quality Of Life and Drug Use in Patients With CAR-T Cells
Pilot Study for Quality Of Life and Drug Use Assessment in Patients With CAR-T Cells
Hospices Civils de Lyon
70 participants
Mar 31, 2021
OBSERVATIONAL
Conditions
Summary
CAR-T cells are a major therapeutic innovation in the management of patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) in 3rd line or more. Kymriah® and Yescarta® are the first CAR-T with Marketing Authorization and coverage by the French Health Insurance. Their clinical interest has been demonstrated in non-comparative phase 1-2 trials. The non-comparative design of the pivotal trials, the lack of data on patients' quality of life and drug consumption, as well as the very high cost of CAR-T (about € 320,000 for one treatment) warrant further studies. This prospective non-comparative study aims to describe in real life the quality of life of patients treated with CAR-T cells, real world drug use and patients' experience feedback.
Eligibility
Inclusion Criteria5
- Over 18 years old
- Eligible for treatment with CAR-T cells (outside any clinical trial) in an indication of DLBCL and for which treatment is scheduled
- Follow-up in the Hematology department of the Hospices Civils de Lyon
- Without major psychiatric disorder likely to interfere with the conduct of the study, in the opinion of the investigator
- Having given his non-opposition to participate in the study.
Exclusion Criteria2
- In an institution
- Under legal protection
Interventions
Interviews and questionnaires will be performed before administration of CAR-T cells, 3 month after and 6 month after, and will last 60 minutes each time. Semi-structured interview using pre-established questionnaires will be completed with a hospital pharmacist, concerning the patient's perception of his family, socio-professional environment, his knowledge of his illness and his treatment, the consumption of prescribed drugs outside the hospital, self-medication, complementary alternative therapies including herbal medicine. Seven self-administered questionnaires will be completed, concerning quality of life, Assessment of Cancer Treatment-Lymphoma, Beliefs about Medicines, Brief Illness Perception, satisfaction with medication, perceived social support scale, and on Health Literacy.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04914091