Cancers 2021, 13, 3826. https://doi.org/10.3390/cancers13153826 www.mdpi.com/journal/cancers Article Randomized Trial Assessing the Impact of Routine Assessment of Health‐Related Quality of Life in Patients with Head and Neck Cancer Oumar Billa 1,2,3 , Franck Bonnetain 4,† , Jérôme Chamois 5,6 , Angeline Ligey 7 , Valérie Ganansia 8 , Georges Noel 8 , Sophie Renard 9 , Sophie Maillard 10 , Magali Quivrin 5 , Noémie Vulquin 5 , Pierre Truntzer 8 , Tienhan Sandrine Dabakuyo‐Yonli 1,2,3 * and Philippe Maingon 5,11 1 Georges‐François Leclerc Cancer Centre‐UNICANCER, Epidemiology and Quality of Life Unit, 21000 Dijon, France; obilla@cgfl.fr 2 Lipids, Nutrition, Cancer Research Center, U1231 INSERM, 21000 Dijon, France 3 National Quality of Life and Cancer Clinical Research Platform, 21000 Dijon, France 4 Methodology and Quality of Life in Oncology Unit, Inserm UMR 1098, University Hospital of Besancon, 25000 Besancon, France; fb@chu‐besancon.fr 5 Georges‐François Leclerc Cancer Centre‐UNICANCER, Radiotherapy Department, 1 Rue Professeur Marion, 21000 Dijon, France; jchamois@vivalto‐sante.com (J.C.); Mquivrin@cgfl.fr (M.Q.); Nvulquin@cgfl.fr (N.V.); Philippe.maingon@aphp.fr (P.M.) 6 Centre Hospitalier Saint Gregoire, 35760 Saint‐Grégoire, France 7 Centre Hospitalier Fleriat, 01012 Bourg‐en‐Bresse, France; Aligey@ch‐bourg01.fr 8 Paul Strauss Cancer Centre‐Unicancer, 67000 Strasbourg, France; Vganansia@strasbourg.unicancer.fr (V.G.); Gnoel@strasbourg.unicancer.fr (G.N.); Ptruntzer@strasbourg.unicancer.fr (P.T.) 9 Institut de cancérologie de Lorraine, 54519 Vandœuvre‐lès‐Nancy, France; Srenard@nancy.unicancer.fr 10 Centre Bourgogne, 59000 Lille, France; Smaillard@ch‐bourg01.fr 11 Radiotherapy Unit, Hôpital de la Pitié‐Salpêtrière‐APHP, 75013 Paris, France * Correspondence: sdabakuyo@cgfl.fr; Tel.: +33‐345‐348‐067 † Deceased. Simple Summary: The purpose of this research was to investigate the impact of routine assessment of health‐related quality of life (HRQoL) on quality of life and satisfaction with care in patients with head and neck cancer (HNC). A randomized controlled open‐label clinical trial with 200 patients with HNC managed in four cancer centers in Eastern France was performed. In the intervention arm (regularly completed HRQoL questionnaires), HRQoL mean change was significantly improved at 2 years from baseline. Compared with the control arm, differences were not statistically significant, but minimal clinically important differences in favor of the intervention arm were found for HRQoL, satisfaction with waiting times, and satisfaction with accessibility. In patients with head and neck cancer undergoing treatments, routine assessment of HRQoL is a simple practice and may have HRQoL and satisfaction benefits. Abstract: The impact of routine assessment of health‐related quality of life (HRQoL) on satisfaction with care and the HRQoL of patients with head and neck cancer (HNC) treated with radiotherapy was assessed. Patients with HNC were randomly assigned to two arms, with stratification on sex, cancer localization, and stage of the disease. In the intervention arm, the patients completed the EORTC QLQ‐C30 and EORTC QLQ‐H&N35 questionnaires first before randomization, then before each medical appointment during radiotherapy (7 weeks), and then every 3 months until 1 year and at 2 years thereafter. In the control arm, the EORTC QLQ‐C30 and EORTC QLQ‐H&N35 questionnaires were completed before randomization and at 1 year and 2 years thereafter. The primary endpoint was mean change in HRQoL at score at 2 years from baseline assessed by EQ VAS from the EuroQol questionnaire. The secondary endpoint was mean change in satisfaction with care at 2 years from baseline assessed by QLQ‐SAT32. Two hundred patients with head and neck cancers were involved in this study (mean age, 58.83 years (range, 36.56–87.89)), of whom 100 were assigned to the intervention arm and 100 to the control arm. Patients in the intervention arm were Citation: Billa, O.; Bonnetain, F.; Chamois, J.; Ligey, A.; Ganansia, V.; Noel, G.; Renard, S.; Maillard, S.; Quivrin, M.; Vulquin, N.; et al. Randomized Trial Assessing the Impact of Routine Assessment of Health‐Related Quality of Life in Patients with Head and Neck Cancer. Cancers 2021, 13, 3826. https://doi.org/10.3390/ cancers13153826 Academic Editor: David Wong Received: 22 June 2021 Accepted: 26 July 2021 Published: 29 July 2021 Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations. Copyright: © 2021 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses /by/4.0/).