Effectiveness of a facilitation programme using a mobile application for initiating advance care planning discussions between patients with advanced cancer and healthcare providers: protocol for a randomised controlled trial (J-SUPPORT 2104)

Introduction Timely implementation of the discussion process of advance care planning (ACP) is recommended. The communication attitude of healthcare providers is critical in ACP facilitation; thus, improving their communication attitudes may reduce patient distress and unnecessary aggressive treatme...

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Main Authors: Tatsuo Akechi, Takuhiro Yamaguchi, Naomi Sakurai, Tempei Miyaji, Yosuke Uchitomi, Narikazu Boku, Maiko Fujimori, Taro Ueno, Shunsuke Oyamada, Masanori Mori, Ayumi Okizaki, Kyoko Obama, Masako Okamura, Midori Kadowaki
Format: Article
Language:English
Published: BMJ Publishing Group 2023-03-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/13/3/e069557.full
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author Tatsuo Akechi
Takuhiro Yamaguchi
Naomi Sakurai
Tempei Miyaji
Yosuke Uchitomi
Narikazu Boku
Maiko Fujimori
Taro Ueno
Shunsuke Oyamada
Masanori Mori
Ayumi Okizaki
Kyoko Obama
Masako Okamura
Midori Kadowaki
author_facet Tatsuo Akechi
Takuhiro Yamaguchi
Naomi Sakurai
Tempei Miyaji
Yosuke Uchitomi
Narikazu Boku
Maiko Fujimori
Taro Ueno
Shunsuke Oyamada
Masanori Mori
Ayumi Okizaki
Kyoko Obama
Masako Okamura
Midori Kadowaki
author_sort Tatsuo Akechi
collection DOAJ
description Introduction Timely implementation of the discussion process of advance care planning (ACP) is recommended. The communication attitude of healthcare providers is critical in ACP facilitation; thus, improving their communication attitudes may reduce patient distress and unnecessary aggressive treatment while enhancing care satisfaction. Digital mobile devices are being developed for behavioural interventions owing to their low space and time restrictions and ease of information sharing. This study aims to evaluate the effectiveness of an intervention programme using an application intended to facilitate patient questioning behaviour on improving communication related to ACP between patients with advanced cancer and healthcare providers.Methods and analysis This study uses a parallel-group, evaluator-blind, randomised controlled trial design. We plan to recruit 264 adult patients with incurable advanced cancer at the National Cancer Centre in Tokyo, Japan. Intervention group participants use a mobile application ACP programme and undergo a 30 min interview with a trained intervention provider for discussions with the oncologist at the next patient visit, while control group participants continue their usual treatment. The primary outcome is the oncologist’s communication behaviour score assessed using audiorecordings of the consultation. Secondary outcomes include communication between patients and oncologists and the patients’ distress, quality of life, care goals and preferences, and medical care utilisation. We will use a full analysis set including the registered participant population who receive at least a part of the intervention.Ethics and dissemination The study protocol was reviewed and approved by the Scientific Advisory Board of the Japan Supportive, Palliative and Psychosocial Oncology Group (Registration No. 2104) and the Institutional Review Board of the National Cancer Centre Hospital (registration No. 2020-500). Written informed consent is obtained from the patients. The results of the trial will be published in peer-reviewed scientific journals and presented at scientific meetings.Trial registration numbers UMIN000045305, NCT05045040.
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spelling doaj.art-8527325bfe87410c84587dfcf485985a2023-08-12T02:20:07ZengBMJ Publishing GroupBMJ Open2044-60552023-03-0113310.1136/bmjopen-2022-069557Effectiveness of a facilitation programme using a mobile application for initiating advance care planning discussions between patients with advanced cancer and healthcare providers: protocol for a randomised controlled trial (J-SUPPORT 2104)Tatsuo Akechi0Takuhiro Yamaguchi1Naomi Sakurai2Tempei Miyaji3Yosuke Uchitomi4Narikazu Boku5Maiko Fujimori6Taro Ueno7Shunsuke Oyamada8Masanori Mori9Ayumi Okizaki10Kyoko Obama11Masako Okamura12Midori Kadowaki13Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya, JapanDivision of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, JapanCancer Survivors Recruiting Project, General Incorporated Association, Tokyo, JapanInstitute for Cancer Control, National Cancer Center Japan, Tokyo, JapanInstitute for Cancer Control, National Cancer Center Japan, Tokyo, JapanDepartment of Oncology and General Medicine, IMSUT Hospital, The Institute of Medical Science, The University of Tokyo, Tokyo, JapanInstitute for Cancer Control, National Cancer Center Japan, Tokyo, JapanSUSMED, Inc, Tokyo, JapanDepartment of Biostatistics, JORTC Data Center, Tokyo, JapanDivision of Palliative and Supportive Care, Seirei Mikatahara Hospital, Hamamatsu, JapanInstitute for Cancer Control, National Cancer Center Japan, Tokyo, JapanInstitute for Cancer Control, National Cancer Center Japan, Tokyo, JapanInstitute for Cancer Control, National Cancer Center Japan, Tokyo, JapanInstitute for Cancer Control, National Cancer Center Japan, Tokyo, JapanIntroduction Timely implementation of the discussion process of advance care planning (ACP) is recommended. The communication attitude of healthcare providers is critical in ACP facilitation; thus, improving their communication attitudes may reduce patient distress and unnecessary aggressive treatment while enhancing care satisfaction. Digital mobile devices are being developed for behavioural interventions owing to their low space and time restrictions and ease of information sharing. This study aims to evaluate the effectiveness of an intervention programme using an application intended to facilitate patient questioning behaviour on improving communication related to ACP between patients with advanced cancer and healthcare providers.Methods and analysis This study uses a parallel-group, evaluator-blind, randomised controlled trial design. We plan to recruit 264 adult patients with incurable advanced cancer at the National Cancer Centre in Tokyo, Japan. Intervention group participants use a mobile application ACP programme and undergo a 30 min interview with a trained intervention provider for discussions with the oncologist at the next patient visit, while control group participants continue their usual treatment. The primary outcome is the oncologist’s communication behaviour score assessed using audiorecordings of the consultation. Secondary outcomes include communication between patients and oncologists and the patients’ distress, quality of life, care goals and preferences, and medical care utilisation. We will use a full analysis set including the registered participant population who receive at least a part of the intervention.Ethics and dissemination The study protocol was reviewed and approved by the Scientific Advisory Board of the Japan Supportive, Palliative and Psychosocial Oncology Group (Registration No. 2104) and the Institutional Review Board of the National Cancer Centre Hospital (registration No. 2020-500). Written informed consent is obtained from the patients. The results of the trial will be published in peer-reviewed scientific journals and presented at scientific meetings.Trial registration numbers UMIN000045305, NCT05045040.https://bmjopen.bmj.com/content/13/3/e069557.full
spellingShingle Tatsuo Akechi
Takuhiro Yamaguchi
Naomi Sakurai
Tempei Miyaji
Yosuke Uchitomi
Narikazu Boku
Maiko Fujimori
Taro Ueno
Shunsuke Oyamada
Masanori Mori
Ayumi Okizaki
Kyoko Obama
Masako Okamura
Midori Kadowaki
Effectiveness of a facilitation programme using a mobile application for initiating advance care planning discussions between patients with advanced cancer and healthcare providers: protocol for a randomised controlled trial (J-SUPPORT 2104)
BMJ Open
title Effectiveness of a facilitation programme using a mobile application for initiating advance care planning discussions between patients with advanced cancer and healthcare providers: protocol for a randomised controlled trial (J-SUPPORT 2104)
title_full Effectiveness of a facilitation programme using a mobile application for initiating advance care planning discussions between patients with advanced cancer and healthcare providers: protocol for a randomised controlled trial (J-SUPPORT 2104)
title_fullStr Effectiveness of a facilitation programme using a mobile application for initiating advance care planning discussions between patients with advanced cancer and healthcare providers: protocol for a randomised controlled trial (J-SUPPORT 2104)
title_full_unstemmed Effectiveness of a facilitation programme using a mobile application for initiating advance care planning discussions between patients with advanced cancer and healthcare providers: protocol for a randomised controlled trial (J-SUPPORT 2104)
title_short Effectiveness of a facilitation programme using a mobile application for initiating advance care planning discussions between patients with advanced cancer and healthcare providers: protocol for a randomised controlled trial (J-SUPPORT 2104)
title_sort effectiveness of a facilitation programme using a mobile application for initiating advance care planning discussions between patients with advanced cancer and healthcare providers protocol for a randomised controlled trial j support 2104
url https://bmjopen.bmj.com/content/13/3/e069557.full
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