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Protocol for a multi-site, cluster‐randomized, phase III, comparative clinical trial of geriatric assessment of older patients with non‐small‐cell lung cancer: the ENSURE-GA study

BACKGROUND: In Japan, approximately half of all lung cancer patients are aged > 75 years, and the proportion of older patients is increasing. In older patients, it is necessary to consider comorbidities and concomitant drug use to ensure optimal cancer treatment; however, geriatric assessment (GA...

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Autores principales: Tsubata, Yukari, Shinomiya, Shun, Inoue, Koji, Ishikawa, Nobuhisa, Saito, Ryota, Nakashima, Kazuhisa, Hotta, Katsuyuki, Hamada, Akinobu, Nagashima, Fumio, Ando, Yuichi, Morita, Satoshi, Kobayashi, Kunihiko, Isobe, Takeshi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7821507/
https://www.ncbi.nlm.nih.gov/pubmed/33482741
http://dx.doi.org/10.1186/s12877-021-02028-w
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author Tsubata, Yukari
Shinomiya, Shun
Inoue, Koji
Ishikawa, Nobuhisa
Saito, Ryota
Nakashima, Kazuhisa
Hotta, Katsuyuki
Hamada, Akinobu
Nagashima, Fumio
Ando, Yuichi
Morita, Satoshi
Kobayashi, Kunihiko
Isobe, Takeshi
author_facet Tsubata, Yukari
Shinomiya, Shun
Inoue, Koji
Ishikawa, Nobuhisa
Saito, Ryota
Nakashima, Kazuhisa
Hotta, Katsuyuki
Hamada, Akinobu
Nagashima, Fumio
Ando, Yuichi
Morita, Satoshi
Kobayashi, Kunihiko
Isobe, Takeshi
author_sort Tsubata, Yukari
collection PubMed
description BACKGROUND: In Japan, approximately half of all lung cancer patients are aged > 75 years, and the proportion of older patients is increasing. In older patients, it is necessary to consider comorbidities and concomitant drug use to ensure optimal cancer treatment; however, geriatric assessment (GA) is not widely performed. We plan to conduct a study (ENSURE-GA) of GA in older lung cancer patients to determine whether GA with intervention improves patient satisfaction with their treatment. METHODS: The study will be a phase III comparative clinical trial with a cluster-randomized design, and it will be conducted at 81 sites distributed throughout Japan. Approximately 1000 lung cancer patients aged ≥ 75 years will be enrolled in the study. All participants will undergo a standardized GA before starting treatment (using an iPad). At the intervention sites, the GA results and intervention method recommended on the basis of the GA results will be returned as an instant report to guide the physician’s choice of intervention. At the control sites, the physician will decide on interventions based on standard practice. All participants will complete a patient satisfaction survey before treatment initiation (after the GA) and 3 months later. DISCUSSION: The purpose of the ENSURE-GA study is to evaluate whether GA with interventions improves patient satisfaction with treatment outcomes. The study may lead to the increased use of GA and improved treatment of cancer in older adults. The results will also be used to prepare guidelines for treating older cancer patients and will provide a foundation for the development of a standardized geriatric oncology system. TRIAL REGISTRATION: The study has been registered in the University Hospital Medical Information Network database (no. UMIN000037590). The registration date is August 4, 2019, and the protocol version is 2.0. (https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000042853.)
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spelling pubmed-78215072021-01-22 Protocol for a multi-site, cluster‐randomized, phase III, comparative clinical trial of geriatric assessment of older patients with non‐small‐cell lung cancer: the ENSURE-GA study Tsubata, Yukari Shinomiya, Shun Inoue, Koji Ishikawa, Nobuhisa Saito, Ryota Nakashima, Kazuhisa Hotta, Katsuyuki Hamada, Akinobu Nagashima, Fumio Ando, Yuichi Morita, Satoshi Kobayashi, Kunihiko Isobe, Takeshi BMC Geriatr Study Protocol BACKGROUND: In Japan, approximately half of all lung cancer patients are aged > 75 years, and the proportion of older patients is increasing. In older patients, it is necessary to consider comorbidities and concomitant drug use to ensure optimal cancer treatment; however, geriatric assessment (GA) is not widely performed. We plan to conduct a study (ENSURE-GA) of GA in older lung cancer patients to determine whether GA with intervention improves patient satisfaction with their treatment. METHODS: The study will be a phase III comparative clinical trial with a cluster-randomized design, and it will be conducted at 81 sites distributed throughout Japan. Approximately 1000 lung cancer patients aged ≥ 75 years will be enrolled in the study. All participants will undergo a standardized GA before starting treatment (using an iPad). At the intervention sites, the GA results and intervention method recommended on the basis of the GA results will be returned as an instant report to guide the physician’s choice of intervention. At the control sites, the physician will decide on interventions based on standard practice. All participants will complete a patient satisfaction survey before treatment initiation (after the GA) and 3 months later. DISCUSSION: The purpose of the ENSURE-GA study is to evaluate whether GA with interventions improves patient satisfaction with treatment outcomes. The study may lead to the increased use of GA and improved treatment of cancer in older adults. The results will also be used to prepare guidelines for treating older cancer patients and will provide a foundation for the development of a standardized geriatric oncology system. TRIAL REGISTRATION: The study has been registered in the University Hospital Medical Information Network database (no. UMIN000037590). The registration date is August 4, 2019, and the protocol version is 2.0. (https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000042853.) BioMed Central 2021-01-22 /pmc/articles/PMC7821507/ /pubmed/33482741 http://dx.doi.org/10.1186/s12877-021-02028-w Text en © The Author(s) 2021 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Tsubata, Yukari
Shinomiya, Shun
Inoue, Koji
Ishikawa, Nobuhisa
Saito, Ryota
Nakashima, Kazuhisa
Hotta, Katsuyuki
Hamada, Akinobu
Nagashima, Fumio
Ando, Yuichi
Morita, Satoshi
Kobayashi, Kunihiko
Isobe, Takeshi
Protocol for a multi-site, cluster‐randomized, phase III, comparative clinical trial of geriatric assessment of older patients with non‐small‐cell lung cancer: the ENSURE-GA study
title Protocol for a multi-site, cluster‐randomized, phase III, comparative clinical trial of geriatric assessment of older patients with non‐small‐cell lung cancer: the ENSURE-GA study
title_full Protocol for a multi-site, cluster‐randomized, phase III, comparative clinical trial of geriatric assessment of older patients with non‐small‐cell lung cancer: the ENSURE-GA study
title_fullStr Protocol for a multi-site, cluster‐randomized, phase III, comparative clinical trial of geriatric assessment of older patients with non‐small‐cell lung cancer: the ENSURE-GA study
title_full_unstemmed Protocol for a multi-site, cluster‐randomized, phase III, comparative clinical trial of geriatric assessment of older patients with non‐small‐cell lung cancer: the ENSURE-GA study
title_short Protocol for a multi-site, cluster‐randomized, phase III, comparative clinical trial of geriatric assessment of older patients with non‐small‐cell lung cancer: the ENSURE-GA study
title_sort protocol for a multi-site, cluster‐randomized, phase iii, comparative clinical trial of geriatric assessment of older patients with non‐small‐cell lung cancer: the ensure-ga study
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7821507/
https://www.ncbi.nlm.nih.gov/pubmed/33482741
http://dx.doi.org/10.1186/s12877-021-02028-w
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