Long-term implications of rare brain tumours
Research type
Research Study
Full title
Understanding the long-term implications of treatment of rare brain tumours on health-related quality of life: A European cross-sectional study
IRAS ID
279885
Contact name
Florien Boele
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
2 years, 9 months, 1 days
Research summary
Rationale: Patients diagnosed with oligodendroglioma with a specific molecular profile represent rare tumour groups (about 10% of adult gliomas) with relatively favourable prognosis (median survival between 8 and 12 years). These patients are often treated with surgery, chemotherapy and/or radiotherapy. However, as patients live for a long period of time, they may also experience long-term toxic side-effects of treatment. The long-term consequences of treatment- and disease-related factors on quality of life and cognitive functioning of these patients is largely unknown.
Objective: To describe quality of life and cognitive functioning in long-term survivors of oligodendroglioma (with IDH mutation and 1p/19q codeletion). This knowledge can support health care professionals prepare patients for any long-term consequences of treatment.
Study design: Cross-sectional multicentre study. Because these tumours are quite rare, we need to work collaboratively across Europe.
Study population: Adult (≥18 years of age) patients diagnosed with a histologically confirmed oligodendroglioma with IDH mutation and 1p/19q co-deletion at least 5 years previously.
Intervention: Not applicable.
Main study parameters/endpoints: Information on disease and treatment (medical records), quality of life, mood, fatigue, subjective cognitive functioning (patient-reported outcomes), and objective cognitive functioning (neuropsychological tests).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no direct benefits for patients participating in this study, but their participation will contribute to better knowledge on long-term consequences of treatment. There are small potential risks: patients are confronted with issues that brain tumor patients have, which may pose a psychological burden on them. Moreover, it will cost patients time to complete study procedures, although this is not substantial.This ethics application is for the UK sites only and the University of Leeds is acting as sponsor for the study taking place in the UK sites.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
20/ES/0046
Date of REC Opinion
27 May 2020
REC opinion
Further Information Favourable Opinion