Assessment of the Quality of Life of Patients With Lymphomas Treated With Oral Therapy

Study Overview
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Brief Summary
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The emergence of new anti-cancer drugs orally administered has revolutionized the prognosis and modalities of management of several lymphomas over the past decade. Today, half of patients receive oral therapy at home. Ibrutinib, acalabrutinib, idelalisib, venetoclax and lenalidomide are oral therapies used in the treatment of Chronic Lymphoid Leukemia, Follicular Lymphoma, Waldenström's disease and mantle cell lymphoma, in relapsing but soon to be 1st line. Nevertheless, clinical trials leading to marketing authorizations for these drugs were performed in a small number of patients and very little data is available on their use in real life conditions. Their impact on the quality of life of patients also remains to be assessed. The aim of this clinical research is to evaluate quality of life of patients at the initiation of the first oral therapy and every year for 5 years. This study will also identify factors (biological and non-biological: quality of life, shared decision-making ...) associated with a good response of patients and follow-up for the occurrence of long-term adverse reactions (5 years).

Detailed Description
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Prospective longitudinal cohort. This observational study is monocentric. For each patient, data will be collected during 5 years.

Official Title
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Assessment of the Quality of Life of Patients With Lymphomas Treated With Oral Therapy

Conditions
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Quality of Life

Intervention / Treatment
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* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients included in the PK-E3i clinical study OR Over the age of 18 Patients with hemopathies and starting treatment with oral therapy (idelalisib, ibrutinib, venetoclax, lenalidomide, acalabrutinib…) Be able to understand the objective and the constraints related to research Patient having read the information notice and the non-objection form Social Security affiliation Exclusion Criteria: Pregnant women Persons under legal protection of adults Patients under judicial protection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oral therapy<br>Patients included in the PK-E3i clinical study or patients with hemopathies starting treatment with oral therapy. | Other: Questionnaire<br>* Questionnaire on the quality of life<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life measurement | Evaluation of the quality of life score, throught the quality of life scale (higher score associated with poor quality of life) | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of patients factors | Collect of clinical and socio-professional characteristics of the patient | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral therapy, lymphoma, quality of life