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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

464 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-14

Study Completion Date

2025-01-01

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).

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Detailed Description

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

Conditions

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Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Oral therapy

Patients included in the PK-E3i clinical study or patients with hemopathies starting treatment with oral therapy.

Questionnaire

Intervention Type OTHER

Questionnaire on the quality of life

Interventions

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Questionnaire

Questionnaire on the quality of life

Intervention Type OTHER

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