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

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

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.

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.