|

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

RECRUITINGSponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Actively Recruiting
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Started2025-04-23
Est. completion2027-10
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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

CancerGliomaGlioma of BrainIDH MutationLow Grade Glioma of BrainLow Grade Gliomas

Interventions1

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.