Clinical trial NCT06890091: Study of the Association Between Fatigue Experienced by Patients and the Specific Side Effects of CART Cells, During the First Month After Administration for Non-Hodgkin's Lymphoma
Official title: Etude de l'Association Entre la Fatigue Ressentie Par Les Patients et Les Effets Secondaires spécifiques Des CART Cells, au Cours du Premier Mois après l'Administration Pour un Lymphome Non Hodgkinien
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Fatigue Symptom
Lymphoma Non-Hodgkin
Chimeric Antigen Receptor T-cell Therapy
Adverse Events
Keywords: Fatigue
CAR-T cells
Chimeric antigen receptor
Adverse events
Lymphoma Non-Hodgkin
Nurse practitionners
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults receiving CAR-T Cell treatment for non-Hodgkin's lymphoma

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?"


Eligibility criteria: 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

Primary outcomes:
measure: Fatigue score
timeFrame: At day 30
Secondary outcomes:
measure: Fatigue score
timeFrame: At inclusion
measure: Fatigue score
timeFrame: At day 2
measure: Fatigue score
timeFrame: At day 10
measure: Fatigue score
timeFrame: At day 21
measure: Physical Fatigue subscore
timeFrame: At inclusion
measure: Physical Fatigue subscore
timeFrame: At day 2
measure: Physical Fatigue subscore
timeFrame: At day 10
measure: Physical Fatigue subscore
timeFrame: At day 21
measure: Physical Fatigue subscore
timeFrame: At day 30
measure: Cognitive Fatigue subscore
timeFrame: At inclusion
measure: Cognitive Fatigue subscore
timeFrame: At 2 days
measure: Cognitive Fatigue subscore
timeFrame: At 10 days
measure: Cognitive Fatigue subscore
timeFrame: At 21 days
measure: Cognitive Fatigue subscore
timeFrame: At 30 days
measure: Emotional Fatigue subscore
timeFrame: At inclusion
measure: Emotional Fatigue subscore
timeFrame: At 2 days
measure: Emotional Fatigue subscore
timeFrame: At 10 days
measure: Emotional Fatigue subscore
timeFrame: At 21 days
measure: Emotional Fatigue subscore
timeFrame: At 30 days
measure: Occurence of side events
timeFrame: Until one month
measure: Severity of side events
timeFrame: Until one month
Other outcomes:
Locations:
Study officials:
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