Quality of life in head and neck cancer survivors: the Big Data for Quality of Life study

Background The Big Data for Quality of Life (BD4QoL) study investigates quality of life (QoL) in head and neck cancer (HNC) survivors, focusing on survivorship and characterizing survivor demographics. Methods We screened data from 5 studies across Europe (N=7276) and included patients with a diagnosis of squamous cell carcinoma (oral cavity, hypopharynx, larynx, oropharynx, nasal cavity and paranasal sinuses), treated with curative intent, alive after treatment, TNM 7th ed. stages I, II, III, IVa and IVb, with availability of QoL questionnaires. Results The cohort of 4448 HNC survivors primarily includes men (78%) with median age 61 years. Most received radiotherapy (75%) and had a history of smoking (78%). Survivors’ scores on EORTC QLQ-C30 functioning scales indicated high functioning, with prevalent symptoms of fatigue, pain, and insomnia. Lower rates of missing data were observed in older patients, those with higher education and income levels, nonsmokers, married individuals, and patients not treated with radiotherapy. The odds ratios ranged from 0.47 to 0.99, indicating these factors may predict more consistent QoL data reporting in HNC survivors. Conclusions These data support the development and validation of clinical prediction models for QoL in HNC survivors in a multicentre randomized controlled trial. ### Competing Interest Statement Marissa LeBlanc reports receiving a speaker fee from MSD unrelated to the content of this work. Susanne Singer reports receiving honoraria for reviewing journal papers for the Quality-of-life-prize of Lilly, outside of this work. Lisa Licitra declares research funds to the institute for clinical studies from Astrazeneca, BMS, Boehringer Ingelheim, Celgene International, Eisai, Exelixis, Debiopharm International SA, Hoffmann-La Roche ltd, IRX Therapeutics, Medpace, Merck-Serono, MSD, Novartis, Pfizer, Roche, Buran, Alentis; occasional fees for participation as a speaker at conferences/congresses or as a scientific consultant for advisory boards from Astrazeneca, Bayer, MSD, Merck-Serono, AccMed, Neutron Therapeutics, Inc. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. ### Funding Statement The BD4QoL project, in the frame of which this work is being conducted, has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 875192. MM-S received funding from the European Union's Horizon 2020 Research and Innovation program under the Marie Sklodowska-Curie Actions Grant, agreement No. 80113 (Scientia fellowship). This Publication presents data from the Head and Neck 5000 study. The study was a component of independent research funded by the National Institute for Health and Care Research (NIHR) under its programme Grands for applied Research scheme (RP-PG-070-10034). The views expressed in this publication are those of the author(s) and are not necessarily those of the NHS, the NIHR or the department of health and Social Care. Core funding was also provided through awards from Above and Beyond, University Hospitals Bristol and Weston Research Capability Funding and the NIHR Senior Investigator award to Professor Andy Ness. The UMM1 study was funded by the German Federal Ministry of Education and Science (Grant Number: 7DZAIQTX), the UMM1 and UMM2 study by the German Cancer Aid (Grant Numbers #106654, #107440, #108758, #109604), the UMM3 study by the European Organisation for Research and Treatment of Cancer (Grant Number: 001/2014). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Our study was conducted in full accordance with ethical principles, including the World Medical Association's Declaration of Helsinki (2002 version). The study protocol received ethical approval by the Norwegian Regional Committee for Medical and Health Research Ethics (REK) South-East D under application number 154191. The data is stored in compliance with GDPR legislation in the secure server for sensitive data at the University of Oslo (TSD/USIT) and access is granted to authorised collaborators included in the ethical approval. Each individual study that provided data received ethical approval from local authorities in Italy, Germany, the UK, and all further countries involved. The data providers submitted copies of these ethical approvals to the principal investigator. BD2Decide study was approved by institutional research ethics board with identifier N. INT 65/16. The HN5000 study was approved by the National Research Ethics Committee (South West Frenchay Ethics Committee, reference number 10/H0107/57, 5 November 2010) and the Research and Development departments of participating NHS Trusts. Informed consent was obtained from all patients recruited to HN5000. UMM1 and UMM2 received ethical approval from the Leipzig University Ethics Committee. UMM3 was approved by Landesaerztekammer Rheinland-Pfalz ethics committee under approval number 837.281.14 (9520). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes