Patient Voice in the Treatment of Low-grade Gliomas: Use of Patient-reported Outcomes, Vorasidenib and Radiotherapy Compared
Conditions:
Glioma
Glioma of Brain
Low Grade Glioma of Brain
Low Grade Gliomas
IDH Mutation
Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
trial.available_in:
БГ
Overview
The study aims to assess the direct patient-reported perception (PROs) of individuals affected by IDH-mutant, grade 2 gliomas undergoing radiotherapy or pharmacological treatment with vorasidenib.
To evaluate quality of life, perception of treatment-related symptoms, and anxiety levels during therapy by comparing patients receiving radiotherapy with those receiving pharmacological treatment with vorasidenib. The control group will consist of patients with IDH-mutant, grade 2 gliomas who are under clinical and radiological follow-up only.
To assess the feasibility of using PROMs in routine clinical practice. To analyze patient-reported critical issues in order to qualitatively improve care pathways.
Description
Patients with IDH-mutant grade 2 gliomas whose therapeutic pathway is defined according to clinical practice.
They are divided into three groups:
* patients receiving pharmacological treatment with vorasidenib, isocitrate dehydrogenase (IDH) inhibitor;
* patients treated with radiotherapy for residual disease or recurrence;
* patients undergoing active surveillance with periodic follow-up including MRI and clinical evaluation.
These patients are asked to complete the questionnaires every 6 months for two years, regardless of the ongoing clinical pathway.
Who can participate
Inclusion Criteria:
* Age \> 18 years
* Histological diagnosis of IDH mutant, grade 2 glioma
* Consent to treatment
* Consent to the administration of PROM questionnaires
Exclusion Criteria:
* Cognitive impairment or mental disability.
* Dementia or severe cognitive disorders: participants who are unable to understand the questionnaire items are excluded, as the data may not be reliable.
* Uncontrolled severe psychiatric disorders: conditions such as schizophrenia or untreated psychosis may compromise the patient's ability to provide consistent responses.
* Language barriers.
* Inability to understand the language of the questionnaire: participants who do not speak or understand the language in which the questionnaire is written are excluded if validated translations are not available.
* Literacy issues: participants who are unable to read or write are excluded.
* Non-adherence or poor cooperation.
* Refusal to complete the questionnaires: even if the patient agrees to participate in the study, the specific refusal to complete the questionnaires leads to exclusion.
* Conditions that may influence questionnaire outcomes.
* Use of medications that impair cognitive abilities: the use of sedatives or antipsychotics may affect the ability to provide coherent responses, compromising the validity of PROs.