Description of Neurocognitive and Psychiatric Disorders Associated with Targeted Therapies Used in the Treatment of Lung Cancers with ALK/ROS1 Fusion and Their Impact on Patients' Quality of Life: Construction of an Experimental Patient-researcher Collaborative Care and Research Pathway

Launched by HOSPICES CIVILS DE LYON · Jan 13, 2025

Keywords

ClinConnect Summary

The DRACONIS project is a clinical trial aimed at understanding the brain and mood problems that some patients with lung cancer experience while being treated with targeted therapies, specifically those for cancers with ALK or ROS1 fusion. These therapies, which are taken in pill form, can be very effective and help patients live longer, sometimes exceeding ten years. However, many patients report issues like memory problems, anxiety, and depression, particularly with one specific drug called lorlatinib. The goal of this study is to carefully evaluate these symptoms and learn how they affect patients' daily lives and overall quality of life.

To be eligible for the trial, participants need to be adults aged 18 or older, currently receiving targeted therapy for ALK/ROS1-positive lung cancer, and able to communicate in French. Participants will undergo neuropsychological evaluations and interviews to share their experiences with any cognitive or mood-related issues they may be facing. This research is a collaborative effort involving patients, doctors, and researchers, and aims to ensure that the unique challenges faced by these patients are recognized and addressed in their treatment plans.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients aged 18 years or older, fluent in French
• • Currently treated with anti-ITK-ALK/ROS1 for ALK/ROS1-positive lung cancer
• • Identified by the prescribing physician as having complaints with or without associated neurocognitive and/or neuropsychiatric disorders related to the treatment.
• Exclusion Criteria:
• • History of neurocognitive and/or neuropsychiatric disorders prior to initiation of anti-ITK-ALK/ROS1 targeted therapy, excluding disorders associated with anti-ITK-ALK/ROS1 or other systemic anticancer treatments
• • Patients with uncontrolled brain metastases or carcinomatous meningitis (requiring symptomatic treatment with corticosteroids progressive or symptomatic)
• • Patients who do not have sufficient proficiency in French to complete questionnaires and/or participate in semi-structured interviews
• • Severe, progressive or unstable medical conditions that may interfere with the evaluation variables (uncontrolled epilepsy, acute psychiatric or psychotic disorders, visual hallucinations, acute infection).
• • Consumption of toxic substances that may affect cognitive performance
• • Deafness or blindness that may compromise participant evaluation or participation in tasks and scales
• • Patients who refuse to participate in the study or are unable to express thein non-opposition to participating in the study