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

Recruiting

• Conditions: Quality of Life
• Interventions: Other: Questionnaire

• Registration Number: NCT04985214
• Lead Sponsor: University Hospital, Toulouse

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).

Detailed Description

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

Study Timeline

• Study Start: 2020-05-14
• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-07-26
• Study First Posted: 2021-08-02
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 464

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oral therapy	Questionnaire	Patients included in the PK-E3i clinical study or patients with hemopathies starting treatment with oral therapy.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Evaluation of patients factors	5 years	Collect of clinical and socio-professional characteristics of the patient

Trial Locations

Locations (14)

Hospices Civils de Lyon; 🇫🇷 Pierre-Bénite, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

CH de Bayonne; 🇫🇷 Bayonne, France

CHU de Grenoble; 🇫🇷 Grenoble, France

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CH Versailles; 🇫🇷 Le Chesnay, France

CHU de Limoges; 🇫🇷 Limoges, France

CHU de Montpellier; 🇫🇷 Montpellier, France

Centre Léon Bérard; 🇫🇷 Lyon, France

CH Le Mans; 🇫🇷 Le Mans, France

CHU de Nîmes; 🇫🇷 Nîmes, France

CH de Perpignan; 🇫🇷 Perpignan, France

Loïc YSEBAERT; 🇫🇷 Toulouse 9, France

CHU de Tours; 🇫🇷 Tours, France