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

Quality of Life Clinical Trial

— EVEREST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04985214
• Other study ID #: RC31/19/0465
• Status: Recruiting
• Start date: May 14, 2020
• Est. completion date: January 1, 2025

Study information

• Verified date: September 2023
• Source: University Hospital, Toulouse
• Contact: Loïc YSEBAERT, Prof.
• Phone: 0531156351
• Email: ysebaert.loic[@]iuct-oncopole.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 464
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Quality of Life

Intervention

Other:
• Questionnaire
Questionnaire on the quality of life

Locations

Country	Name	City	State
France	CH de Bayonne	Bayonne
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	CHU de Grenoble	Grenoble
France	CH Versailles	Le Chesnay
France	CH Le Mans	Le Mans
France	CHU de Limoges	Limoges
France	Centre Léon Bérard	Lyon
France	Institut Paoli Calmettes	Marseille
France	CHU de Montpellier	Montpellier
France	CHU de Nîmes	Nîmes
France	CH de Perpignan	Perpignan
France	Hospices Civils de Lyon	Pierre-Bénite
France	Loïc YSEBAERT	Toulouse 9
France	CHU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of patients factors	Collect of clinical and socio-professional characteristics of the patient	5 years