Monitoring multidimensional aspects of quality of life after cancer immunotherapy: protocol for the international multicentre, observational QUALITOP cohort study
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 t...
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| Format: | Article |
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BMJ Publishing Group
2023-04-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/4/e069090.full |
| _version_ | 1797838076212412416 |
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| author | Geertruida H De Bock Delphine Maucort-Boulch Clémence Leyrat Amélie Anota Stephane Dalle Susana Puig Marie Préau Mohammad S Jalali Marie-Jose Kersten Martijn GH van Oijen Mathieu Fauvernier Petra C. Vinke Marc Combalia Anne Mea Spanjaart Maria Gomes da Silva Aurore Fouda Essongue Aurélie Rabier Myriam Pannard Amal Elgammal Mike Papazoglou Mohand-Said Hacid Catherine Rioufol Erick Suazo-Zepeda Ananya Malhotra Emmanuel Coquery Elsa Coz |
| author_facet | Geertruida H De Bock Delphine Maucort-Boulch Clémence Leyrat Amélie Anota Stephane Dalle Susana Puig Marie Préau Mohammad S Jalali Marie-Jose Kersten Martijn GH van Oijen Mathieu Fauvernier Petra C. Vinke Marc Combalia Anne Mea Spanjaart Maria Gomes da Silva Aurore Fouda Essongue Aurélie Rabier Myriam Pannard Amal Elgammal Mike Papazoglou Mohand-Said Hacid Catherine Rioufol Erick Suazo-Zepeda Ananya Malhotra Emmanuel Coquery Elsa Coz |
| author_sort | Geertruida H De Bock |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-09T15:35:00Z |
| format | Article |
| id | doaj.art-f0459fb57ecf4fbf88aa688bc3bf3ad3 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-09T15:35:00Z |
| publishDate | 2023-04-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-f0459fb57ecf4fbf88aa688bc3bf3ad32023-04-28T00:00:06ZengBMJ Publishing GroupBMJ Open2044-60552023-04-0113410.1136/bmjopen-2022-069090Monitoring multidimensional aspects of quality of life after cancer immunotherapy: protocol for the international multicentre, observational QUALITOP cohort studyGeertruida H De Bock0Delphine Maucort-Boulch1Clémence Leyrat2Amélie Anota3Stephane Dalle4Susana Puig5Marie Préau6Mohammad S Jalali7Marie-Jose Kersten8Martijn GH van Oijen9Mathieu Fauvernier10Petra C. Vinke11Marc Combalia12Anne Mea Spanjaart13Maria Gomes da Silva14Aurore Fouda Essongue15Aurélie Rabier16Myriam Pannard17Amal Elgammal18Mike Papazoglou19Mohand-Said Hacid20Catherine Rioufol21Erick Suazo-Zepeda22Ananya Malhotra23Emmanuel Coquery24Elsa Coz251University Medical Center Groningen; University of Groningen; Gynaecologic OncologyUMR 5558, Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique-Santé, CNRS, Villeurbanne, FranceMedical Statistics, London School of Hygiene and Tropical Medicine, London, UK9 French National Platform Quality of Life and Cancer, Besançon, France2 Dermatology, Centre Hospitalier Universitaire de Lyon, Lyon, Rhône-Alpes, FranceInstituto de Salud Carlos III, Centro de Investigación Biomédica en Red de Enfermedades Raras, Barcelona, SpainINSERM Unit U1296 Radiation: Defence, Health, Environment, Lumière University Lyon 2 Psychology Institute, Bron, France3 MGH Institute for Technology Assessment, Harvard Medical School, Boston, Massachusetts, USAHematology, Amsterdam University Medical Centres, Amsterdam, The Netherlands1Department of Gastroenterology and Hepatology, University Medical Centre Utrecht, Utrecht, The NetherlandsService de Biostatistiques, Hospices Civils de Lyon, Lyon, FranceEpidemiology, University Medical Centre Groningen, University of Groningen, Groningen, The NetherlandsInstitut d`Investigacions Biomediques August Pi i Sunyer, Barcelona, SpainHematology, Amsterdam University Medical Centres, Amsterdam, The NetherlandsHematology, Portuguese Institute of Oncology, Lisboa, PortugalImmuCare, Cancer Institute of the Hospices Civils de Lyon, Lyon, FranceImmuCare, Cancer Institute of the Hospices Civils de Lyon, Lyon, FranceINSERM Unit U1296 Radiation: Defence, Health, Environment, Lumière University Lyon 2 Psychology Institute, Bron, FranceEgypt University of Informatics, Cairo, EgyptScientific Academy for Service Technology e.V. (ServTech), Potsdam, GermanyLIRIS, CNRS UMR 5205, Universite Claude Bernard Lyon 1, Villeurbanne, FranceClinical Oncology Pharmacy Department, Hospital Lyon-South, Cancer Institute of the Hospices Civils de Lyon, Pierre-Benite, FranceEpidemiology, University Medical Centre Groningen, University of Groningen, Groningen, The NetherlandsFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UKLIRIS, CNRS UMR 5205, Universite Claude Bernard Lyon 1, Villeurbanne, FranceUniversity Claude Bernard Lyon 1, Villeurbanne, FranceIntroduction 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.https://bmjopen.bmj.com/content/13/4/e069090.full |
| spellingShingle | Geertruida H De Bock Delphine Maucort-Boulch Clémence Leyrat Amélie Anota Stephane Dalle Susana Puig Marie Préau Mohammad S Jalali Marie-Jose Kersten Martijn GH van Oijen Mathieu Fauvernier Petra C. Vinke Marc Combalia Anne Mea Spanjaart Maria Gomes da Silva Aurore Fouda Essongue Aurélie Rabier Myriam Pannard Amal Elgammal Mike Papazoglou Mohand-Said Hacid Catherine Rioufol Erick Suazo-Zepeda Ananya Malhotra Emmanuel Coquery Elsa Coz Monitoring multidimensional aspects of quality of life after cancer immunotherapy: protocol for the international multicentre, observational QUALITOP cohort study BMJ Open |
| title | Monitoring multidimensional aspects of quality of life after cancer immunotherapy: protocol for the international multicentre, observational QUALITOP cohort study |
| title_full | Monitoring multidimensional aspects of quality of life after cancer immunotherapy: protocol for the international multicentre, observational QUALITOP cohort study |
| title_fullStr | Monitoring multidimensional aspects of quality of life after cancer immunotherapy: protocol for the international multicentre, observational QUALITOP cohort study |
| title_full_unstemmed | Monitoring multidimensional aspects of quality of life after cancer immunotherapy: protocol for the international multicentre, observational QUALITOP cohort study |
| title_short | Monitoring multidimensional aspects of quality of life after cancer immunotherapy: protocol for the international multicentre, observational QUALITOP cohort study |
| title_sort | monitoring multidimensional aspects of quality of life after cancer immunotherapy protocol for the international multicentre observational qualitop cohort study |
| url | https://bmjopen.bmj.com/content/13/4/e069090.full |
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