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

NCT ID: NCT06890091

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-05-01

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?"

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adults receiving CAR-T Cell treatment for non-Hodgkin's lymphoma

Fatigue assessment

Intervention Type: OTHER

Fatigue score measured by the EORTC QLQ-FA 12 fatigue self-assessment scale

Interventions

Fatigue assessment

Fatigue score measured by the EORTC QLQ-FA 12 fatigue self-assessment scale

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Maxime Berquier, MD

Role: CONTACT

maxime.berquier@aphp.fr

+33142494585 ext. +331424991

Jérôme Lambert, MD PhD

Role: CONTACT

jerome.lambert@u-paris.fr

+33 1 42 49 97 42 ext. +33

Other Identifiers

APHP241779

Identifier Type: -

Identifier Source: org_study_id