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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fatigue assessment.
- Who it may be relevant to
- Registry conditions: Fatigue Symptom, Lymphoma Non-Hodgkin, Chimeric Antigen Receptor T-cell Therapy, Adverse Events. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Other Fatigue assessment
Fatigue score measured by the EORTC QLQ-FA 12 fatigue self-assessment scale
Primary outcome measures
- Fatigue score [Time frame: At day 30]
Secondary outcome measures (12)
- Fatigue score [Time frame: At inclusion]
- Fatigue score [Time frame: At day 2]
- Fatigue score [Time frame: At day 10]
- Fatigue score [Time frame: At day 21]
- Physical Fatigue subscore [Time frame: At inclusion]
- Physical Fatigue subscore [Time frame: At day 2]
- Physical Fatigue subscore [Time frame: At day 10]
- Physical Fatigue subscore [Time frame: At day 21]
- Physical Fatigue subscore [Time frame: At day 30]
- Cognitive Fatigue subscore [Time frame: At inclusion]
- Cognitive Fatigue subscore [Time frame: At 2 days]
- Cognitive Fatigue subscore [Time frame: At 10 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06890091 · APHP241779