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 Besta
90 participants
Apr 23, 2025
OBSERVATIONAL
Conditions
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 Criteria4
- Age > 18 years
- Histological diagnosis of IDH mutant, grade 2 glioma
- Consent to treatment
- Consent to the administration of PROM questionnaires
Exclusion Criteria10
- 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.
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Interventions
patients receiving pharmacological treatment with vorasidenib, isocitrate dehydrogenase (IDH) inhibitor;
Radiotherapy: patients treated with radiotherapy for residual disease or recurrence;
Follow-up: patients undergoing active surveillance with periodic follow-up including MRI and clinical evaluation.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07547163