NCT04985214

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 464 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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

Conditions

• Quality of Life

Interventions

Type	Name	Description
OTHER	Questionnaire	Questionnaire on the quality of life

Timeline

• Start date: 2020-05-14
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2021-08-02
• Last updated: 2023-09-21

Locations

14 sites across 1 country: France