TY - JOUR
T1 - A randomised controlled trial of a case management approach to encourage participation in colorectal cancer screening for people with schizophrenia in psychiatric outpatient clinics
T2 - Study protocol for the J-SUPPORT 1901 (ACCESS) study
AU - Fujiwara, Masaki
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
AU - Okada, Hiroyuki
AU - Uchitomi, Yosuke
AU - Yamada, Norihito
N1 - Funding Information:
1Department of Neuropsychiatry, Okayama University Hospital, Okayama, Japan 2Department of Psychiatry, Faculty of Medicine, Shimane University, Izumo, Japan 3Division of Prevention, Epidemiology and Prevention Group, Center for Public Health Sciences, National Cancer Center, Tokyo, Japan 4Okayama Psychiatric Medical Center, Okayama, Japan 5Zikei Hospital, Okayama, Japan 6Division of Health Care Research, Behavioral Sciences and Survivorship Research Group and Division of Cohort Consortium Research, Epidemiology and Prevention Group, Center for Public Health Sciences, National Cancer Center, Tokyo, Japan 7Division of Screening Assessment and Management, Epidemiology and Prevention Group, Center for Public Health Sciences, National Cancer Center, Tokyo, Japan 8Department of Health Sciences, Saitama Prefectural University, Koshigaya, Japan 9Department of Preventive Medicine and Epidemiology, Tohoku Medical Megabank Organization, Tohoku University, Sendai, Japan 10Department of Neuropsychiatry, Kochi Medical School, Kochi University, Nankoku, Japan 11Department of Clinical Trial Data Management, Tokyo University Graduate School of Medicine, Tokyo, Japan 12Department of Biostatistics, Sapporo Medical University, Sapporo, Japan 13Department of Gastroenterology, Okayama University Hospital, Okayama, Japan 14Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan 15Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital and Behavioral Sciences and Survivorship Research Group, Center for Public Health Sciences, National Cancer Center, Tokyo, Japan 16Department of Neuropsychiatry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan Acknowledgements This study is supported by the Japan Supportive, Palliative and Psychosocial Oncology Group (J-SUPPORT). We thank Ms M Kurosaki for her data management support. We also thank Ms S Yoshimoto, Ms S Hino, Ms K
Funding Information:
Competing interests MF received lecture fees from Mochida, Eli Lilly and Sumitomo Dainippon, and personal fees from the Iyaku (Medicine and Drug) Journal and Igaku-Shoin outside the submitted work. MI received grants from Novartis outside the submitted work and lecture fees from Meiji, Mochida, Takeda, Novartis, Yoshitomi, Pfizer, Eisai, Otsuka, MSD and Sumitomo Dainippon and personal fees from Technomics. MI's institution received grants or research support from Eisai, Astellas, Pfizer, Daiichi-Sankyo, Takeda and MSD outside the submitted work. RS received grants from Kobayashi Magobe Foundation outside the submitted work, and lecture fees from Otsuka and personal fees from Kagakuhyronsha, Medical Review, Igaku Shoin and CureApp outside the submitted work. KK received lecture fees from Mochida outside the submitted work. NY received grants from Otsuka, Astellas, MSD, Pfizer and Takeda outside the submitted work, and lecture fees from Otsuka, Astellas, MSD, Pfizer, Meiji, Janssen, Hisamitsu, Sumitomo Dainippon, Mochida, Tsumura, Takeda, Taiho and UCB Japan outside the submitted work.
Funding Information:
Funding This study is supported by the Research for Promotion of Cancer Control Programmes from the Japanese Ministry of Health, Labour and Welfare.
Publisher Copyright:
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2019/11/1
Y1 - 2019/11/1
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.
AB - 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.
KW - cancer screening
KW - case management
KW - disability
KW - early detection of cancer
KW - schizophrenia
KW - severe mental illness
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UR - http://www.scopus.com/inward/citedby.url?scp=85074403991&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2019-032955
DO - 10.1136/bmjopen-2019-032955
M3 - Article
C2 - 31678957
AN - SCOPUS:85074403991
SN - 2044-6055
VL - 9
JO - BMJ Open
JF - BMJ Open
IS - 11
M1 - e032955
ER -
