Informations générales (source: ClinicalTrials.gov)
Development of an EORTC Immune Checkpoint Inhibitor-specific Quality of Life Item List: Phase 1 & 2 (EORTC ICI)
Observational
Institut Curie (Voir sur ClinicalTrials)
octobre 2022
avril 2025
29 juin 2024
Over the past 20 years, the views and experiences of patients in the field of oncology
(through patient-reported outcomes, PROMs) have become increasingly important. When used
in clinical trials, PROMs contribute to better detection and are used in clinical trials
to improve the detection and management of treatment side effects. The Health-related
quality of life assessments are widely used in oncology research, and the development of
reliable and valid measurement instruments has become a major challenge.
In this context, health-related quality of life in cancer patients covers various aspects
(functional status, physical or psychological symptoms) and several cancer-specific
measurement instruments have been developed, including the EORTC QLQ-C30 quality of life
questionnaire.
Among the different therapies used to treat cancers, immunotherapy with immune checkpoint
inhibitors has been gaining momentum in recent years. Commonly used to treat a wide
variety of cancers, it also has a wide range of known side effects.
However, little is known about the health-related quality of life of patients patients
who receive this therapy: specific self-questionnaires are almost non-existent or
inadequate, not covering all the effects related to immune checkpoint inhibitor toxicity.
As for the data currently collected, they suffer from methodological problems.
In view of the increasing use of immune checkpoint inhibitors in cancer treatment, their
known side effects and the lack of valid questionnaires specific to these treatments, it
appears important to provide a valid questionnaire to take into account these impacts on
the quality of life of patients.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | Anne Brédart | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Provision of written informed consent to participate in the study
- Has been diagnosed with cancer
- Either currently receiving, or has received in the previous 12 months, one of the
following:
- an anti-PD-1 or anti-PDL-1 agent as the sole immune checkpoint inhibitor
treatment (at least three cycles)
- an anti-PD-1 or anti-PDL-1 agent in combination with an anti-CTLA-4 agent (at
least one cycle)
- cytotoxic chemotherapy and an anti-PD-1 or anti-PDL-1 agent (at least three
cycles)
- Aged ≥18 years
- Provision of written informed consent to participate in the study
- Has been diagnosed with cancer
- Either currently receiving, or has received in the previous 12 months, one of the
following:
- an anti-PD-1 or anti-PDL-1 agent as the sole immune checkpoint inhibitor
treatment (at least three cycles)
- an anti-PD-1 or anti-PDL-1 agent in combination with an anti-CTLA-4 agent (at
least one cycle)
- cytotoxic chemotherapy and an anti-PD-1 or anti-PDL-1 agent (at least three
cycles)
- Aged ≥18 years
- Has an additional primary cancer for which they are receiving systemic therapy
- Cognitive impairment which presents an obstacle to the completion of questionnaires
or an interview
- Poor command of the locally dominant language, or an inability to read questions
- [Phase 1b only] Was interviewed for Phase 1a
Healthcare professionals :
Inclusion Criteria:
- Holds, or has held, a professional clinical position which involves working directly
with cancer patients who are in receipt of immune checkpoint inhibitors
- Is a medical oncologist, nurse specialist (or equivalent), psychologist, or social
worker
Exclusion Criteria:
• Has met the inclusion criteria for <1 years