Adverse Events, Chimeric Antigen Receptor T-cell Therapy, Fatigue Symptom, Lymphoma Non-Hodgkin
Conditions
Keywords
Fatigue, CAR-T cells, Chimeric antigen receptor, Adverse events, Lymphoma Non-Hodgkin, Nurse practitionners
Brief summary
The incidence of cancer in 2023 is estimated at 433136 cases, according to INCa. Haemopathies account for 12% of these new cases of cancer cases of cancer, and around two-thirds are lymphoid haemopathies, in particular lymphomas. There are many treatments available for lymphoma. However, the arrival in France in 2018 of immunotherapy treatments such as CAR-T Cells have changed the paradigm of treatment options for certain non-Hodgkin's lymphomas. In these treatments can have both short-term and long-term adverse effects and long-term adverse effects. During hospitalisation for the administration of CAR-T Cells, acute side effects include CRS and ICANS. There is also another complication very specific to this treatment that has been observed in patients: cytopenias. This is despite the fact that one of the symptoms frequently mentioned and felt by patients during the first month after month after treatment is fatigue. Despite numerous studies on the prevalence of fatigue, healthcare professionals often underestimate this symptom. Nurses, and in particular the advanced practice nurse have a crucial role to play in assessing fatigue. The EORTC scale QLQ-FA12 is a multidimensional scale which assesses the physical emotional and cognitive dimensions of fatigue. The theory of symptom management, which was developed in 1994 by the California College of Nursing in San Francisco, is a relevant framework for understanding fatigue in patients. This theory places the patient's experience at the centre of care. This holistic approach provides a detailed framework for understanding this symptom. According to the theoretical model, measuring the symptom is an important step and characterising it is an essential element in better targeting the actions to be taken. Although CAR-T Cell therapy is innovative and allows long-term remissions, it is important to evaluate and understand how patients live with this treatment. To our knowledge, few studies have been carried out on quality of life, particularly regarding fatigue, following the first month of CAR-T Cell administration. The research question we will address in this study is: Is there an association between the side effects of CAR-T Cell treatment and the state of fatigue in patients receiving this treatment for non-Hodgkin's lymphoma during the first month?
Interventions
OTHERFatigue assessment
Fatigue score measured by the EORTC QLQ-FA 12 fatigue self-assessment scale
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (age\> 18year old) * Person hospitalised for treatment with CAR-T Cells for non-Hodgkin's lymphoma. * Person able to understand and read the French language.
Exclusion criteria
* Patient under legal protection * Opposition to research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue score | At day 30 | European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue. 30 days after CAR-T cell injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Fatigue subscore | At inclusion | European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue. 5 days before CAR-T cells injection |
| Cognitive Fatigue subscore | At inclusion | European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue. 5 days before CAR-T cells injection |
| Fatigue score | At inclusion | European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue. 5 days before CAR-T cells injection |
| Occurence of side events | Until one month | — |
| Severity of side events | Until one month | — |
| Emotional Fatigue subscore | At inclusion | European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue. 5 days before CAR-T cells injection |
Contacts
Primary ContactMaxime Berquier, MD
Backup ContactJérôme Lambert, MD PhD
Outcome results
None listed