Patient Voice in the Treatment of Low-grade Gliomas: Use of Patient-reported Outcomes, Vorasidenib and Radiotherapy Compared

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta90 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Glioma Glioma of Brain Low Grade Glioma of Brain Low Grade Gliomas

Interventions

VorasidenibDRUG

patients receiving pharmacological treatment with vorasidenib, isocitrate dehydrogenase (IDH) inhibitor;

RadiotherapyPROCEDURE

Radiotherapy: patients treated with radiotherapy for residual disease or recurrence;

active surveillancePROCEDURE

Follow-up: patients undergoing active surveillance with periodic follow-up including MRI and clinical evaluation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Characterize and compare the experience of patients with IDH-mutant, grade 2 gliomas

To characterize and compare the experience of patients with IDH-mutant, grade 2 gliomas through the administration of PROs across different settings: radiotherapy, medical oncology, and in the absence of adjuvant treatments. Use of standardized questionnaires 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.

Time frame: 3 years