Rationale and design of the PROMETCO study: A real-world, prospective, longitudinal cohort on the continuum of care of metastatic colorectal cancer from a clinical and patient perspective
Koopman, Miriam; Pinto, Carmine; Bodoky, György; Garcia-Carbonero, Rocio; Marti, Francisca Marti; Bachet, Jean Baptiste
(2022) Future Oncology, volume 18, issue 11, pp. 1313 - 1320
(Article)
Abstract
The PROMETCO study is collecting real-world data on metastatic colorectal cancer (mCRC) patients with two progressions. This international, prospective, longitudinal, observational cohort study is collecting data on mCRC patients with two disease progressions since diagnosis and receiving subsequent treatment. Objectives include overall survival, treatment patterns, effectiveness and safety and patient-reported
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outcomes using the EuroQol 5-level, 5-dimensional questionnaire, the Brief Fatigue Inventory and a modified version of the ACCEPTance by the Patients of their Treatment (ACCEPT ©) questionnaire. Data are collected retrospectively and prospectively up to 18 months. As of 13 October 2021, 544 patients from 18 countries had been enrolled. To the authors' knowledge, PROMETCO is the first international, real-world study of the continuum of care of mCRC patients in this setting. Trial registration number: NCT03935763 (ClinicalTrials.gov).
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Keywords: Continuum of care, Metastatic colorectal cancer, Patient-reported outcomes, Real-world evidence, Study design, Survival, Treatment patterns, Prospective Studies, Humans, Continuity of Patient Care, Colorectal Neoplasms/drug therapy, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Observational Studies as Topic, Retrospective Studies, Cohort Studies, Oncology, Cancer Research, Review, Journal Article
ISSN: 1479-6694
Publisher: Taylor and Francis Ltd.
Note: Funding Information: This study is sponsored by Servier Affaires Médicales, France. M Koopman has acted as an advisory board member for Nordic Farma, Merck-Serono, Pierre Fabre and Servier and received scientific grants from Bayer, Bristol Myers Squibb, Merck, Roche and Servier. Carmine Pinto has received honoraria for acting as an advisory board member or speaker for Amgen, Astellas, AstraZeneca, Bayer, BMS, Janssen, Lilly, Merck-Serono, MSD, Novartis, Roche, Sanofi and Servier. G Bodoky has acted as an advisory board member or speaker for Roche, Bayer, Janssen, Novartis, Pfizer, BMS and Merck. R Garcia-Carbonero has provided scientific advice and/or received honoraria from AAA, Advanz Pharma, Amgen, Bayer, BMS, HMP, Ipsen, Lilly, Merck, Midatech Pharma, MSD, Novartis, PharmaMar, Pfizer, Roche and Sanofi and has received research support from Pfizer, BMS and MSD. F Marti Marti has received honoraria from Servier. J-B Bachet has received personal fees from Amgen, AstraZeneca, Bayer, Merck Serono, Pierre Fabre, Roche, Sanofi and Servier and non-financial support from Amgen, Merck Serono, Roche and Servier. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Publisher Copyright: ©) questionnaire. Data are collected retrospectively and prospectively up to 18 months. As of 13 October 2021, 544 patients from 18 countries had been enrolled. To the authors' knowledge, PROMETCO is the first international, real-world study of the continuum of care of mCRC patients in this setting.
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