EVEREST: Assessment of the Quality of Life of Patients With Lymphomas Treated With Oral Therapy
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Prospective longitudinal cohort. This observational study is monocentric. For each patient, data will be collected during 5 years.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Oral therapy Patients included in the PK-E3i clinical study or patients with hemopathies starting treatment with oral therapy. |
Other: Questionnaire
Questionnaire on the quality of life
|
Outcome Measures
Primary Outcome Measures
- Quality of life measurement [5 years]
Evaluation of the quality of life score, throught the quality of life scale (higher score associated with poor quality of life)
Secondary Outcome Measures
- Evaluation of patients factors [5 years]
Collect of clinical and socio-professional characteristics of the patient
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients included in the PK-E3i clinical study OR
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Over the age of 18
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Patients with hemopathies and starting treatment with oral therapy (idelalisib, ibrutinib, venetoclax, lenalidomide, acalabrutinib…)
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Be able to understand the objective and the constraints related to research
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Patient having read the information notice and the non-objection form
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Social Security affiliation
Exclusion Criteria:
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Pregnant women
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Persons under legal protection of adults
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Patients under judicial protection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Loïc YSEBAERT | Toulouse 9 | France | 31059 |
Sponsors and Collaborators
- University Hospital, Toulouse
Investigators
- Principal Investigator: Loïc YSEBAERT, Prof., University Hospital, Toulouse
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC31/19/0465