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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?"
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults receiving CAR-T Cell treatment for non-Hodgkin's lymphoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fatigue assessment | Other | Fatigue score measured by the EORTC QLQ-FA 12 fatigue self-assessment scale |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue score | 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 | At day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue score | 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 | At inclusion |
| Fatigue score |
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Inclusion Criteria:
Exclusion Criteria:
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Adults receiving CAR-T Cell treatment for non-Hodgkin's lymphoma
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maxime Berquier, MD | Contact | +33142494585 | +331424991 | maxime.berquier@aphp.fr |
| Jérôme Lambert, MD PhD | Contact | +33 1 42 49 97 42 | +33 | jerome.lambert@u-paris.fr |
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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 |
| At day 2 |
| Fatigue score | 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 | At day 10 |
| Fatigue score | 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 | At day 21 |
| Physical Fatigue subscore | 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 | At inclusion |
| Physical Fatigue subscore | 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 | At day 2 |
| Physical Fatigue subscore | 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. 10 days after CAR-T cells injection | At day 10 |
| Physical Fatigue subscore | 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. 21 days after CAR-T cells injection | At day 21 |
| Physical Fatigue subscore | 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 | At day 30 |
| Cognitive Fatigue subscore | 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 | At inclusion |
| Cognitive Fatigue subscore | 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 | At 2 days |
| Cognitive Fatigue subscore | 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. 10 days after CAR-T cells injection | At 10 days |
| Cognitive Fatigue subscore | 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. 21 days after CAR-T cells injection | At 21 days |
| Cognitive Fatigue subscore | 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 | At 30 days |
| Emotional Fatigue subscore | 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 | At inclusion |
| Emotional Fatigue subscore | 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 | At 2 days |
| Emotional Fatigue subscore | 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. 10 days after CAR-T cells injection | At 10 days |
| Emotional Fatigue subscore | 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. 21 days after CAR-T cells injection | At 21 days |
| Emotional Fatigue subscore | 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 | At 30 days |
| Occurence of side events | Until one month |
| Severity of side events | Until one month |
| ID | Term |
|---|---|
| D005221 | Fatigue |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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