Glioma, Glioma of Brain, Low Grade Glioma of Brain, Low Grade Gliomas, IDH Mutation
Conditions
Keywords
Patient Reported Outcomes, glioma, Low Grade Gliomas, grade 2 glioma, IDH mutant
Brief 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.
Detailed 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.
Interventions
DRUGVorasidenib
patients receiving pharmacological treatment with vorasidenib, isocitrate dehydrogenase (IDH) inhibitor;
PROCEDURERadiotherapy
Radiotherapy: patients treated with radiotherapy for residual disease or recurrence;
PROCEDUREactive surveillance
Follow-up: patients undergoing active surveillance with periodic follow-up including MRI and clinical evaluation.
Sponsors
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterize and compare the experience of patients with IDH-mutant, grade 2 gliomas | 3 years | 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. |
Countries
Italy
Contacts
CONTACTCristiana Pedone, MD
PRINCIPAL_INVESTIGATORSara Morlino, MD
Fondazione IRCCS Istituto Neurologico Carlo Besta
Outcome results
None listed