Patient Voice in the Treatment of Low-grade Gliomas: Use of Patient-reported Outcomes, Vorasideni… (NCT07547163) | Clinical Trial Compass
RecruitingNot Applicable
Patient Voice in the Treatment of Low-grade Gliomas: Use of Patient-reported Outcomes, Vorasidenib and Radiotherapy Compared
Italy90 participantsStarted 2025-04-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing vorasidenib and radiotherapy based on patient-reported outcomes for IDH-mutant grade 2 gliomas — does my tumor have an IDH mutation, and does that make me a potential candidate worth discussing with you?
2Since this trial is listed as Phase NA and seems focused on measuring the patient experience rather than testing a new treatment's safety or effectiveness, can you help me understand what I would actually be doing if I participated — would I be receiving a specific treatment, completing surveys, or both?
3The trial is comparing vorasidenib to radiotherapy — are either of these already considered a standard-of-care option for my situation, and how does what I might receive in this trial compare to what you would recommend outside of it?
4Because this study is specifically focused on characterizing what patients with low-grade gliomas go through during treatment, what kinds of patient-reported outcomes or quality-of-life measures would I be expected to complete, and how much of a time commitment would that involve?
5Given that my diagnosis involves a low-grade glioma, which can sometimes be managed with a watch-and-wait approach, would joining a study that requires active treatment like vorasidenib or radiotherapy be the right first step for me, or is watchful waiting still worth considering?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Characterize and compare the experience of patients with IDH-mutant, grade 2 gliomas
Timeframe: 3 years
Trial details
NCT IDNCT07547163
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta