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

Summary

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.

Eligibility

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.

Conditions6

Interventions1

Related trials

• Vorasidenib Maintenance for IDH Mutant Astrocytoma — European Organisation for Research and Treatment of Cancer - EORTC
• Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma — iOMEDICO AG

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