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Protocol for the ASTRO study (SSOP-01): a multicentre prospective cohort study investigating adverse events based on electronic patient-reported outcomes in patients with breast cancer after adjuvant chemotherapy

INTRODUCTION: Symptom-related adverse events associated with perioperative chemotherapy in patients with breast cancer include short-term adverse events such as nausea and vomiting. However, changes in the severity and duration of prolonged symptom-related adverse events have not been fully investig...

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Autores principales: Kuniyoshi, Ouki, Sano, Motohiko, Nakano, Yasuhiro, Kawaguchi, Takashi, Hatakeyama, Tomoki, Tsuchiya, Yusuke, Inada, Yusuke, Harada, Tomohiko, Kurosaki, Miyuki, Mashiko, Tomoe, Miyaji, Tempei, Yamaguchi, Takuhiro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10503369/
https://www.ncbi.nlm.nih.gov/pubmed/37709306
http://dx.doi.org/10.1136/bmjopen-2022-071500
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author Kuniyoshi, Ouki
Sano, Motohiko
Nakano, Yasuhiro
Kawaguchi, Takashi
Hatakeyama, Tomoki
Tsuchiya, Yusuke
Inada, Yusuke
Harada, Tomohiko
Kurosaki, Miyuki
Mashiko, Tomoe
Miyaji, Tempei
Yamaguchi, Takuhiro
author_facet Kuniyoshi, Ouki
Sano, Motohiko
Nakano, Yasuhiro
Kawaguchi, Takashi
Hatakeyama, Tomoki
Tsuchiya, Yusuke
Inada, Yusuke
Harada, Tomohiko
Kurosaki, Miyuki
Mashiko, Tomoe
Miyaji, Tempei
Yamaguchi, Takuhiro
author_sort Kuniyoshi, Ouki
collection PubMed
description INTRODUCTION: Symptom-related adverse events associated with perioperative chemotherapy in patients with breast cancer include short-term adverse events such as nausea and vomiting. However, changes in the severity and duration of prolonged symptom-related adverse events have not been fully investigated. We present a protocol of a study that aims to clarify the prevalence of symptom-related adverse events in patients with breast cancer 1 year after neoadjuvant or adjuvant chemotherapy using an electronic patient-reported outcomes (ePRO) system. METHODS AND ANALYSIS: This multicentre prospective observational cohort study will include patients with breast cancer who have received preoperative or postoperative adjuvant chemotherapy. The final injection date of the cytotoxic agent will be the study initiation date. Patients will report every 2 weeks from the initiation date to 12 weeks and every 4 weeks from 12 weeks to 1 year, and they can enter this information into the ePRO system from anywhere. The primary outcome will be the prevalence of symptom-related adverse events according to the ePRO system 1 year after the date of the last injection of the cytotoxic drug used in neoadjuvant or adjuvant chemotherapy for breast cancer. To increase multi-institutional enrolment, two cohorts will be included. Cohort 1 will comprise patients with acquisition of baseline patient information regarding preoperative chemotherapy and presurgery characteristics. Cohort 2 will comprise patients without acquisition of baseline patient information. The target sample size is ≥250 per year. ETHICS AND DISSEMINATION: The study protocol has been approved by the ethics committee at each participating institution. The results will be presented at major national and international conferences and submitted to peer-reviewed journals. TRIAL STATUS: Registration was started in October 2021. By August 2022, a total of 132 participants were enrolled. Follow-up will be continued through December 2024. TRIAL REGISTRATION NUMBER: UMIN000045422.
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spelling pubmed-105033692023-09-16 Protocol for the ASTRO study (SSOP-01): a multicentre prospective cohort study investigating adverse events based on electronic patient-reported outcomes in patients with breast cancer after adjuvant chemotherapy Kuniyoshi, Ouki Sano, Motohiko Nakano, Yasuhiro Kawaguchi, Takashi Hatakeyama, Tomoki Tsuchiya, Yusuke Inada, Yusuke Harada, Tomohiko Kurosaki, Miyuki Mashiko, Tomoe Miyaji, Tempei Yamaguchi, Takuhiro BMJ Open Patient-Centred Medicine INTRODUCTION: Symptom-related adverse events associated with perioperative chemotherapy in patients with breast cancer include short-term adverse events such as nausea and vomiting. However, changes in the severity and duration of prolonged symptom-related adverse events have not been fully investigated. We present a protocol of a study that aims to clarify the prevalence of symptom-related adverse events in patients with breast cancer 1 year after neoadjuvant or adjuvant chemotherapy using an electronic patient-reported outcomes (ePRO) system. METHODS AND ANALYSIS: This multicentre prospective observational cohort study will include patients with breast cancer who have received preoperative or postoperative adjuvant chemotherapy. The final injection date of the cytotoxic agent will be the study initiation date. Patients will report every 2 weeks from the initiation date to 12 weeks and every 4 weeks from 12 weeks to 1 year, and they can enter this information into the ePRO system from anywhere. The primary outcome will be the prevalence of symptom-related adverse events according to the ePRO system 1 year after the date of the last injection of the cytotoxic drug used in neoadjuvant or adjuvant chemotherapy for breast cancer. To increase multi-institutional enrolment, two cohorts will be included. Cohort 1 will comprise patients with acquisition of baseline patient information regarding preoperative chemotherapy and presurgery characteristics. Cohort 2 will comprise patients without acquisition of baseline patient information. The target sample size is ≥250 per year. ETHICS AND DISSEMINATION: The study protocol has been approved by the ethics committee at each participating institution. The results will be presented at major national and international conferences and submitted to peer-reviewed journals. TRIAL STATUS: Registration was started in October 2021. By August 2022, a total of 132 participants were enrolled. Follow-up will be continued through December 2024. TRIAL REGISTRATION NUMBER: UMIN000045422. BMJ Publishing Group 2023-09-14 /pmc/articles/PMC10503369/ /pubmed/37709306 http://dx.doi.org/10.1136/bmjopen-2022-071500 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Patient-Centred Medicine
Kuniyoshi, Ouki
Sano, Motohiko
Nakano, Yasuhiro
Kawaguchi, Takashi
Hatakeyama, Tomoki
Tsuchiya, Yusuke
Inada, Yusuke
Harada, Tomohiko
Kurosaki, Miyuki
Mashiko, Tomoe
Miyaji, Tempei
Yamaguchi, Takuhiro
Protocol for the ASTRO study (SSOP-01): a multicentre prospective cohort study investigating adverse events based on electronic patient-reported outcomes in patients with breast cancer after adjuvant chemotherapy
title Protocol for the ASTRO study (SSOP-01): a multicentre prospective cohort study investigating adverse events based on electronic patient-reported outcomes in patients with breast cancer after adjuvant chemotherapy
title_full Protocol for the ASTRO study (SSOP-01): a multicentre prospective cohort study investigating adverse events based on electronic patient-reported outcomes in patients with breast cancer after adjuvant chemotherapy
title_fullStr Protocol for the ASTRO study (SSOP-01): a multicentre prospective cohort study investigating adverse events based on electronic patient-reported outcomes in patients with breast cancer after adjuvant chemotherapy
title_full_unstemmed Protocol for the ASTRO study (SSOP-01): a multicentre prospective cohort study investigating adverse events based on electronic patient-reported outcomes in patients with breast cancer after adjuvant chemotherapy
title_short Protocol for the ASTRO study (SSOP-01): a multicentre prospective cohort study investigating adverse events based on electronic patient-reported outcomes in patients with breast cancer after adjuvant chemotherapy
title_sort protocol for the astro study (ssop-01): a multicentre prospective cohort study investigating adverse events based on electronic patient-reported outcomes in patients with breast cancer after adjuvant chemotherapy
topic Patient-Centred Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10503369/
https://www.ncbi.nlm.nih.gov/pubmed/37709306
http://dx.doi.org/10.1136/bmjopen-2022-071500
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