A randomised controlled trial of a case management approach to encourage participation in colorectal cancer screening for people with schizophrenia in psychiatric outpatient clinics: Study protocol for the J-SUPPORT 1901 (ACCESS) study

Masaki Fujiwara, Masatoshi Inagaki, Taichi Shimazu, Masafumi Kodama, Ryuhei So, Takanori Matsushita, Yusaku Yoshimura, Shigeo Horii, Maiko Fujimori, Hirokazu Takahashi, Naoki Nakaya, Kyoko Kakeda, Tempei Miyaji, Shiro Hinotsu, Keita Harada, Hiroyuki Okada, Yosuke Uchitomi, Norihito Yamada

Research output: Contribution to journalArticle

Abstract

Introduction One of the reasons for the high mortality rate from cancer in people with schizophrenia is delay in diagnosis. Many studies have shown lower cancer screening rates in people with schizophrenia; however, there are no interventions for people with schizophrenia to increase cancer screening. Therefore, we developed a case management (CM) intervention to encourage participation in cancer screening. The purpose of this study was to examine the efficacy of CM to encourage participation in cancer screening for people with schizophrenia, with particular focus on colorectal cancer screening by faecal occult blood testing, compared with usual intervention (UI), namely, municipal public education. Methods and analysis This is an individually randomised, parallel group trial with blinded outcome assessments. The participants will be randomly allocated to either the CM plus UI group or UI alone group in a 1:1 ratio using a web-based program at a data management centre. The primary end point of the study is participation in colorectal cancer screening in the year of intervention, which will be assessed based on municipal records. Ethics and dissemination This study is performed in accordance with Ethical Guidelines for Medical and Health Research Involving Human Subjects published by Japan's Ministry of Education, Science, and Technology and the Ministry of Health, Labour, and Welfare and the modified Act on the Protection of Personal Information as well as the Declaration of Helsinki. This study was approved by the institutional ethics committee at the Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences and Okayama University Hospital on 23 April 2019 (approval number: RIN1904-003). The findings of this trial will be submitted to an international peer-reviewed journal. Trial registration number UMIN000036017.

Original languageEnglish
Article numbere032955
JournalBMJ Open
Volume9
Issue number11
DOIs
Publication statusPublished - Nov 1 2019

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Case Management
Ambulatory Care Facilities
Early Detection of Cancer
Psychiatry
Colorectal Neoplasms
Schizophrenia
Randomized Controlled Trials
Helsinki Declaration
School Dentistry
Computer Security
Education
Occult Blood
Ethics Committees
Biomedical Technology
Ethics
Biomedical Research
Japan
Medicine
Outcome Assessment (Health Care)
Guidelines

Keywords

  • cancer screening
  • case management
  • disability
  • early detection of cancer
  • schizophrenia
  • severe mental illness

ASJC Scopus subject areas

  • Medicine(all)

Cite this

A randomised controlled trial of a case management approach to encourage participation in colorectal cancer screening for people with schizophrenia in psychiatric outpatient clinics : Study protocol for the J-SUPPORT 1901 (ACCESS) study. / Fujiwara, Masaki; Inagaki, Masatoshi; Shimazu, Taichi; Kodama, Masafumi; So, Ryuhei; Matsushita, Takanori; Yoshimura, Yusaku; Horii, Shigeo; Fujimori, Maiko; Takahashi, Hirokazu; Nakaya, Naoki; Kakeda, Kyoko; Miyaji, Tempei; Hinotsu, Shiro; Harada, Keita; Okada, Hiroyuki; Uchitomi, Yosuke; Yamada, Norihito.

In: BMJ Open, Vol. 9, No. 11, e032955, 01.11.2019.

Research output: Contribution to journalArticle

Fujiwara, Masaki ; Inagaki, Masatoshi ; Shimazu, Taichi ; Kodama, Masafumi ; So, Ryuhei ; Matsushita, Takanori ; Yoshimura, Yusaku ; Horii, Shigeo ; Fujimori, Maiko ; Takahashi, Hirokazu ; Nakaya, Naoki ; Kakeda, Kyoko ; Miyaji, Tempei ; Hinotsu, Shiro ; Harada, Keita ; Okada, Hiroyuki ; Uchitomi, Yosuke ; Yamada, Norihito. / A randomised controlled trial of a case management approach to encourage participation in colorectal cancer screening for people with schizophrenia in psychiatric outpatient clinics : Study protocol for the J-SUPPORT 1901 (ACCESS) study. In: BMJ Open. 2019 ; Vol. 9, No. 11.
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abstract = "Introduction One of the reasons for the high mortality rate from cancer in people with schizophrenia is delay in diagnosis. Many studies have shown lower cancer screening rates in people with schizophrenia; however, there are no interventions for people with schizophrenia to increase cancer screening. Therefore, we developed a case management (CM) intervention to encourage participation in cancer screening. The purpose of this study was to examine the efficacy of CM to encourage participation in cancer screening for people with schizophrenia, with particular focus on colorectal cancer screening by faecal occult blood testing, compared with usual intervention (UI), namely, municipal public education. Methods and analysis This is an individually randomised, parallel group trial with blinded outcome assessments. The participants will be randomly allocated to either the CM plus UI group or UI alone group in a 1:1 ratio using a web-based program at a data management centre. The primary end point of the study is participation in colorectal cancer screening in the year of intervention, which will be assessed based on municipal records. Ethics and dissemination This study is performed in accordance with Ethical Guidelines for Medical and Health Research Involving Human Subjects published by Japan's Ministry of Education, Science, and Technology and the Ministry of Health, Labour, and Welfare and the modified Act on the Protection of Personal Information as well as the Declaration of Helsinki. This study was approved by the institutional ethics committee at the Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences and Okayama University Hospital on 23 April 2019 (approval number: RIN1904-003). The findings of this trial will be submitted to an international peer-reviewed journal. Trial registration number UMIN000036017.",
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AU - Inagaki, Masatoshi

AU - Shimazu, Taichi

AU - Kodama, Masafumi

AU - So, Ryuhei

AU - Matsushita, Takanori

AU - Yoshimura, Yusaku

AU - Horii, Shigeo

AU - Fujimori, Maiko

AU - Takahashi, Hirokazu

AU - Nakaya, Naoki

AU - Kakeda, Kyoko

AU - Miyaji, Tempei

AU - Hinotsu, Shiro

AU - Harada, Keita

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N2 - Introduction One of the reasons for the high mortality rate from cancer in people with schizophrenia is delay in diagnosis. Many studies have shown lower cancer screening rates in people with schizophrenia; however, there are no interventions for people with schizophrenia to increase cancer screening. Therefore, we developed a case management (CM) intervention to encourage participation in cancer screening. The purpose of this study was to examine the efficacy of CM to encourage participation in cancer screening for people with schizophrenia, with particular focus on colorectal cancer screening by faecal occult blood testing, compared with usual intervention (UI), namely, municipal public education. Methods and analysis This is an individually randomised, parallel group trial with blinded outcome assessments. The participants will be randomly allocated to either the CM plus UI group or UI alone group in a 1:1 ratio using a web-based program at a data management centre. The primary end point of the study is participation in colorectal cancer screening in the year of intervention, which will be assessed based on municipal records. Ethics and dissemination This study is performed in accordance with Ethical Guidelines for Medical and Health Research Involving Human Subjects published by Japan's Ministry of Education, Science, and Technology and the Ministry of Health, Labour, and Welfare and the modified Act on the Protection of Personal Information as well as the Declaration of Helsinki. This study was approved by the institutional ethics committee at the Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences and Okayama University Hospital on 23 April 2019 (approval number: RIN1904-003). The findings of this trial will be submitted to an international peer-reviewed journal. Trial registration number UMIN000036017.

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