Cancer types
  • Head and neck
Title of study
Multicentre validation of the Dutch FACE-Q head and neck cancer module
Version Number
Approval Date 
2.1, 2 July 2020
Short Title
FACE-Q
Study site
Principle Investigator
Prof. dr. L.E. Smeele (NKI/AvL)
Investigator Maastro
F. Hoebers, MD, PhD
Sponsor
Netherlands Cancer Institute (NCI/AvL)
Trial registry
Objectives 

Assess the psychometric properties of the FACE-Q HNC in terms of (based on COSMIN tool):
1. Content validity: does the PROM measure what it should measure?
2. Known groups validity: are the FACE-Q subscales able to distinguish clinical relevant differences in predefined subgroups (see hypothesis)
3. Convergent validity in comparison with the Dutch EORTC H&N35: are the ranges of FACE-Q scores comparable to the EORTC scores? 4. Identify and correct for cross-cultural differences compared to the original FACE-Q cohort that was used for development

Primary Endpoint 

To assess if; – the PROM measures what it should measure; – the FACE-Q subscales are able to distinguish clinically relevant differences in predefined subgroups; – the ranges of FACE-Q scores are comparable to the EORTC scores.

Secondary Endpoints 

– Response rates
– Distribution and range of scores
– Assessment of additional group formation

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