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Studying patient reported outcome tools in brain tumour patients

Establishing the content coverage of available Patient-Reported Outcome (PRO) measures used in neuro-oncology - RANO-PRO

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/09/027724
Enrollment
500
Registered
2020-09-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C719- Malignant neoplasm of brain, unspecified

Interventions

None listed

Sponsors

Leiden University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients are eligible for participation if they meet the following criteria: - They are diagnosed with a glioma, PCNSL, meningioma, or intracranial brain metastases; - They are adult patients: >=18 years of age; - They have signed the informed consent form. Proxies are eligible for participation if they meet the following criteria: - They are adults: >=18 years of age; - They are spouse, family member, or close friend of the patient; - They have signed the informed consent form. HCPs are eligible for participation if they meet the following criteria: - They work as neurologist, neurosurgeon, medical oncologist, radiation oncologist, neuropsychologist or specialist nurse in neuro-oncology; - They have at least 2 years of experience with primary brain tumours (glioma, PCNSL or meningioma) and/or metastatic (intracranial) brain tumours OR; - They treat patients with primary brain tumours (glioma, PCNSL or meningioma) and/or metastatic (intracranial) brain tumours in their daily practice (at least 20 per year).

Exclusion criteria

Exclusion criteria: Patients are not considered eligible for study participation if: - They are not eligible for participating in the study according to the treating physician, due to very poor physical condition or unable to provide consent to research participation (i.e. filling in the survey); - They cannot complete the survey due to a language barrier or limited understanding of the survey. Proxies are not considered eligible for study participation if: - They cannot complete the survey due to a language barrier or limited understanding of the survey.

Design outcomes

Primary

MeasureTime frame
The aim of this study is to establish the content validity of the available PRO measures used in primary and secondary brain tumour patients. Content coverage of the identified PRO measures will be defined as the percentage of items considered relevant (based on the survey results, see the statistical analysis for the determination of relevance). In addition, the percentage of relevant items that are not covered by the PRO measure will be defined and considered. Timepoint: This will be a prospective cross-sectional study. The study-specific survey will be sent one time to a convenience sample of brain tumour patients with a glioma, primary central nervous system lymphoma (PCNSL), meningioma or intracranial brain metastases and their proxies (informal caregivers) attending an outpatient clinic

Secondary

MeasureTime frame
Baseline characteristics of participating patients, including age, gender, level of education, relationship status, living arrangements, employment status, Karnofsky Performance Score (KPS), date of diagnosis, disease status, and current and previous anti-tumour treatments.Timepoint: This being a cross-sectional study, only the base-line characteristics will be analysed which will be collected at a given point of time only once during the course of the study

Countries

Belgium, India, Netherlands, Switzerland, United Kingdom, United States of America

Contacts

Public ContactRakesh Jalali

Apollo Proton Cancer Centre

rjalali@apollohospitals.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026