TY - JOUR
T1 - Monitoring multidimensional aspects of quality of life after cancer immunotherapy
T2 - protocol for the international multicentre, observational QUALITOP cohort study
AU - Vinke, Petra C.
AU - Combalia, Marc
AU - de Bock, Geertruida H.
AU - Leyrat, Clémence
AU - Spanjaart, Anne Mea
AU - Dalle, Stephane
AU - Gomes da Silva, Maria
AU - Fouda Essongue, Aurore
AU - Rabier, Aurélie
AU - Pannard, Myriam
AU - Jalali, Mohammad S.
AU - Elgammal, Amal
AU - Papazoglou, Mike
AU - Hacid, Mohand-Said
AU - Rioufol, Catherine
AU - Kersten, Marie-José
AU - van Oijen, Martijn Gh
AU - Suazo-Zepeda, Erick
AU - Malhotra, Ananya
AU - Coquery, Emmanuel
AU - Anota, Amélie
AU - Preau, Marie
AU - Fauvernier, Mathieu
AU - Coz, Elsa
AU - Puig, Susana
AU - Maucort-Boulch, Delphine
N1 - Funding Information: This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement Nº 875171. Additionally, the UK Medical Research Council is supporting CL (Skills Development Fellowship, MR/T032448/1). The funding sources did not play a role in the design of the study, collection of data or writing of this protocol. Publisher Copyright: © 2023 BMJ Publishing Group. All rights reserved.
PY - 2023/4/27
Y1 - 2023/4/27
N2 - Introduction Immunotherapies, such as immune checkpoint inhibitors and chimeric antigen receptor T-cell therapy, have significantly improved the clinical outcomes of various malignancies. However, they also cause immune-related adverse events (irAEs) that can be challenging to predict, prevent and treat. Although they likely interact with health-related quality of life (HRQoL), most existing evidence on this topic has come from clinical trials with eligibility criteria that may not accurately reflect real-world settings. The QUALITOP project will study HRQoL in relation to irAEs and its determinants in a real-world study of patients treated with immunotherapy. Methods and analysis This international, observational, multicentre study takes place in France, the Netherlands, Portugal and Spain. We aim to include about 1800 adult patients with cancer treated with immunotherapy in a specifically recruited prospective cohort, and to additionally obtain data from historical real-world databases (ie, databiobanks) and medical administrative registries (ie, national cancer registries) in which relevant data regarding other adult patients with cancer treated with immunotherapy has already been stored. In the prospective cohort, clinical health status, HRQoL and psychosocial well-being will be monitored until 18 months after treatment initiation through questionnaires (at baseline and 3, 6, 12 and 18 months thereafter), and by data extraction from electronic patient files. Using advanced statistical methods, including causal inference methods, artificial intelligence algorithms and simulation modelling, we will use data from the QUALITOP cohort to improve the understanding of the complex relationships among treatment regimens, patient characteristics, irAEs and HRQoL. Ethics and dissemination All aspects of the QUALITOP project will be conducted in accordance with the Declaration of Helsinki and with ethical approval from a suitable local ethics committee, and all patients will provide signed informed consent. In addition to standard dissemination efforts in the scientific literature, the data and outcomes will contribute to a smart digital platform and medical data lake. These will (1) help increase knowledge about the impact of immunotherapy, (2) facilitate improved interactions between patients, clinicians and the general population and (3) contribute to personalised medicine. Trial registration number NCT05626764.
AB - Introduction Immunotherapies, such as immune checkpoint inhibitors and chimeric antigen receptor T-cell therapy, have significantly improved the clinical outcomes of various malignancies. However, they also cause immune-related adverse events (irAEs) that can be challenging to predict, prevent and treat. Although they likely interact with health-related quality of life (HRQoL), most existing evidence on this topic has come from clinical trials with eligibility criteria that may not accurately reflect real-world settings. The QUALITOP project will study HRQoL in relation to irAEs and its determinants in a real-world study of patients treated with immunotherapy. Methods and analysis This international, observational, multicentre study takes place in France, the Netherlands, Portugal and Spain. We aim to include about 1800 adult patients with cancer treated with immunotherapy in a specifically recruited prospective cohort, and to additionally obtain data from historical real-world databases (ie, databiobanks) and medical administrative registries (ie, national cancer registries) in which relevant data regarding other adult patients with cancer treated with immunotherapy has already been stored. In the prospective cohort, clinical health status, HRQoL and psychosocial well-being will be monitored until 18 months after treatment initiation through questionnaires (at baseline and 3, 6, 12 and 18 months thereafter), and by data extraction from electronic patient files. Using advanced statistical methods, including causal inference methods, artificial intelligence algorithms and simulation modelling, we will use data from the QUALITOP cohort to improve the understanding of the complex relationships among treatment regimens, patient characteristics, irAEs and HRQoL. Ethics and dissemination All aspects of the QUALITOP project will be conducted in accordance with the Declaration of Helsinki and with ethical approval from a suitable local ethics committee, and all patients will provide signed informed consent. In addition to standard dissemination efforts in the scientific literature, the data and outcomes will contribute to a smart digital platform and medical data lake. These will (1) help increase knowledge about the impact of immunotherapy, (2) facilitate improved interactions between patients, clinicians and the general population and (3) contribute to personalised medicine. Trial registration number NCT05626764.
KW - Adverse events
KW - Epidemiology
KW - ONCOLOGY
UR - http://www.scopus.com/inward/record.url?scp=85158908676&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/bmjopen-2022-069090
DO - https://doi.org/10.1136/bmjopen-2022-069090
M3 - Article
C2 - 37105689
SN - 2044-6055
VL - 13
JO - BMJ Open
JF - BMJ Open
IS - 4
M1 - e069090
ER -