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

Not yet recruiting

• Conditions: Fatigue Symptom; Lymphoma Non-Hodgkin; Chimeric Antigen Receptor T-cell Therapy; Adverse Events

• Registration Number: NCT06890091
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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?"

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-03-17
• Last Update Submitted: 2025-03-17
• Study First Posted: 2025-03-21
• Last Update Posted: 2025-03-21
• Study Start: 2025-04-01
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Cognitive Fatigue subscore	At 30 days	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 cells injection
Severity of side events	Until one month
Fatigue score	At day 21	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.; 2 days after CAR-T cells injection
Emotional Fatigue subscore	At 30 days	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 cells injection
Physical Fatigue subscore	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 cells injection
Occurence of side events	Until one month