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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Vorasidenib
  patients receiving pharmacological treatment with vorasidenib, isocitrate dehydrogenase (IDH) inhibitor;
• Процедура Radiotherapy
  Radiotherapy: patients treated with radiotherapy for residual disease or recurrence;
• Процедура active surveillance
  Follow-up: patients undergoing active surveillance with periodic follow-up including MRI and clinical evaluation.

Первичные конечные точки

• Characterize and compare the experience of patients with IDH-mutant, grade 2 gliomas [Срок оценки: 3 years]

Критерии участия

Критерии включения

• Age > 18 years
• Histological diagnosis of IDH mutant, grade 2 glioma
• Consent to treatment
• Consent to the administration of PROM questionnaires

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Италия · 1 центр

• Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan

Публикации

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Идентификаторы

NCT: NCT07547163 · LGG PRO's

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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