Academic Journal

Monitoring multidimensional aspects of quality of life after cancer immunotherapy:protocol for the international multicentre, observational QUALITOP cohort study

التفاصيل البيبلوغرافية
العنوان: Monitoring multidimensional aspects of quality of life after cancer immunotherapy:protocol for the international multicentre, observational QUALITOP cohort study
المؤلفون: Vinke, Petra C., Combalia, Marc, De Bock, Geertruida H., Leyrat, Clémence, Spanjaart, Anne Mea, Dalle, Stephane, Gomes Da Silva, Maria, Fouda Essongue, Aurore, Rabier, Aurélie, Pannard, Myriam, Jalali, Mohammad S., Elgammal, Amal, Papazoglou, Mike, Hacid, Mohand-Said, Rioufol, Catherine, Kersten, Marie José, Van Oijen, Martijn G. H., Suazo-Zepeda, Erick, Malhotra, Ananya, Coquery, Emmanuel, Anota, Amélie, Preau, Marie, Fauvernier, Mathieu, Coz, Elsa, Puig, Susana, Maucort-Boulch, Delphine
المصدر: Vinke , P C , Combalia , M , De Bock , G H , Leyrat , C , Spanjaart , A M , Dalle , S , Gomes Da Silva , M , Fouda Essongue , A , Rabier , A , Pannard , M , Jalali , M S , Elgammal , A , Papazoglou , M , Hacid , M-S , Rioufol , C , Kersten , M J , Van Oijen , M G H , Suazo-Zepeda , E , Malhotra , A , Coquery , E , Anota , A , Preau , M ....
سنة النشر: 2023
الوصف: 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 ...
نوع الوثيقة: article in journal/newspaper
وصف الملف: application/pdf
اللغة: English
DOI: 10.1136/bmjopen-2022-069090
الاتاحة: https://researchers.mq.edu.au/en/publications/8b9e7c1a-c7f1-49c7-bac2-2c02ef3adf43
https://doi.org/10.1136/bmjopen-2022-069090
https://research-management.mq.edu.au/ws/files/348109658/Publisher_version_open_access_.pdf
http://www.scopus.com/inward/record.url?scp=85158908676&partnerID=8YFLogxK
Rights: info:eu-repo/semantics/openAccess
رقم الانضمام: edsbas.DA74D116
قاعدة البيانات: BASE
الوصف
DOI:10.1136/bmjopen-2022-069090