NET-QUBIC

(NETherlands QUality of life and Biomedical cohort studies In Cancer)

Research over the past decades provided convincing evidence that cancer patients have to deal with various physical, psycho-behavioural and social side effects of cancer and cancer treatment, negatively affecting quality of life (QoL). Particularly in understudied cancer populations such as head and neck cancer (HNC), little is known about the course of QoL, and its determinants across the disease-span. In addition, there is limited insight in the prognostic value of QoL on survival. This association can be influenced by various cancer-related, personal, biological, psycho-behavioural, lifestyle-related and social factors. Comprehensive insight in all these factors, assessed in a standardized manner is necessary to unravel these complex associations.

Objectives
The primary objective of NET-QUBIC is to describe the long term course of QoL in newly-diagnosed cancer patients and to identify cancer-related, personal, biological, psycho-behavioural, physical, lifestyle-related, and social determinants of QoL.

Secondary aims are

• to investigate the association between QoL and survival in cancer patients, taking into account broadly defined cancer-related, personal, biological, psycho-behavioural, lifestyle-related, and social determinants;

• to build predictive models for long term QoL and survival of cancer patients;

• to determine whether the association between QoL and survival is direct or mediated by cancer-related, personal, biological, psycho-behavioural, lifestyle-related, and social factors;

• to prospectively examine patients’ supportive care needs in all phases of the disease (from diagnosis to the terminal phase), and the association with the long-term course of QoL.

Method
NET-QUBIC is a longitudinal observational cohort study, following up on cancer patients over 5 years.
The first work package of NET-QUBIC will include 1000 newly-diagnosed  head and neck cancer patients, aged > 18 years, with life expectancies > 3 months. These patients will be recruited from several university Medical Centers in The Netherlands.

Assessments will take place before the start of primary cancer treatment which is approximately 3 weeks after diagnosis (baseline), and at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months follow-up. Disease specific and tumour specific QoL is assessed with the EORTC QLQ-C30 and EORTC QLQ-HN60, respectively. Cancer-related, personal, biological, psycho-behavioural, physical, lifestyle-related, and social factors will be assessed using patient reported outcomes, face-to-face interviews, medical examinations, and biological samples.

Results
In the first phase of NET-QUBIC, we will conduct a pilot study to test the feasibility of assessing the comprehensive set outcome measures. Currently, the preparations for the pilot study are being conducted. For the pilot study, 15 newly diagnosed HNC patients will be recruited from VUmc. We will evaluate our set of outcome measures, the research burden, both physically and mentally, and whether intimacy of certain questions, for example regarding sexuality, is accepted. Furthermore, the protocols and instructions designed for NET-QUBIC will be evaluated. If necessary, changes will be made to the protocols before the start of the cohort study.

Duration of NET-QUBIC
8 years

Funding

Alpe d’HuZes foundation/Dutch Cancer Society

Staff
Research physician:
A.J. van Nieuwenhuizen, MD, physician, dpt. of Otolaryngology-Head & Neck Surgery, VUmc

Principle investigators:
Prof I.M. Verdonck-de Leeuw, PhD, Psychologist, Speech & Language Therapist, Linguïst, dpt. of Otolaryngology-Head & Neck Surgery, VUmc and dpt of Clinical Psychology, VU Faculty of Psychology and Education.
Prof C.R. Leemans, PhD MD, Head & Neck Surgeon, Ent Specialist, dpt. of Otolaryngology-Head & Neck Surgery, VUmc
L.M. Buffart, PhD, Human movement scientist, epidemiologist, EMGO Institute for Health and Care research and the dpt. of Epidemiology and Biostatistics, VUmc

Questions?
For questions, please contact:
Laurien Buffart, PhD
Email: l.buffart@vumc.nl
Phone: + 31 (0)20-4449931