UMIN-CTR Clinical Trial

Basic information
Public title	A cross-sectional study of cancer screening behavior and smoking behavior among people with serious mental illness.
Acronym	Health-related behaviors and serious mental illness
Scientific Title	A cross-sectional study of cancer screening behavior and smoking behavior among people with serious mental illness.
Scientific Title:Acronym	Health-related behaviors and serious mental illness
Region	Japan

Condition
Condition	Schizophrenia (including schizoaffective disorder)
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to investigate the utilization of cancer screening and smoking behavior, and to identify the factors associated with those health-related behaviors among people with schizophrenia.
Basic objectives2	Others
Basic objectives -Others	Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Prevalence of cancer screenings Distribution of stages in the process of quitting smoking
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key inclusion criteria	Diagnosis of schizophrenia or schizoaffective disorder according to the DSM-5 criteria. Patients who have visited the hospital of the study site for 1 or more years. Patients who visited the hospital twice or more in the last 6 months. Aged between 20 and 69 years.
Key exclusion criteria	Diagnosis of intellectual disability, substance/medication-induced psychotic disorder, or psychotic disorder due to another medical condition Patients who are not appropriate for participation in the study as judged by the physician Patients who do not read or write in Japanese
Target sample size	420

Research contact person
Name of lead principal investigator	1st name Norihito Middle name Last name Yamada
Organization	Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name	Department of Neuropsychiatry
Zip code	700-8558
Address	2-5-1, Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.
TEL	086-235-7246
Email	nyamada@okayama-u.ac.jp

Public contact
Name of contact person	1st name Masaki Middle name Last name Fujiwara
Organization	Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name	Department of Neuropsychiatry
Zip code	700-8558
Address	2-5-1, Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.
TEL	086-235-7246
Homepage URL
Email	mfujiwara@okayama-u.ac.jp

Sponsor
Institute	Department of Neuropsychiatry, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science
Institute
Department

Funding Source
Organization	Okayama Health Foundation Novartis Pharma Research Grants Okayama University Research for Promotion of Cancer Control Programs (H26-political-general-002)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Okayama Psychiatric Medical Center Department of Preventive Medicine and Epidemiology, Tohoku Medical Megabank Organization, Tohoku University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address	2-5-1, Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.
Tel	086-235-6938
Email	mae6605@adm.okayama-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 01 Day

Related information
URL releasing protocol	NA
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.1111/pcn.12554
Number of participants that the trial has enrolled	350
Results	https://doi.org/10.1111/pcn.12554 https://doi.org/10.1620/tjem.244.209 https://doi.org/10.1186/s12888-019-2351-9 https://doi.org/10.18926/AMO/62226
Results date posted	2022 Year 06 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2017 Year 09 Month 05 Day
Baseline Characteristics	https://doi.org/10.1111/pcn.12554
Participant flow	https://doi.org/10.1111/pcn.12554
Adverse events	none
Outcome measures	https://doi.org/10.1111/pcn.12554
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 15 Day
Date of IRB	2016 Year 02 Month 23 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date	2017 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

-Cancer screening 1) Main The point estimates and 95% confidence intervals (CIs) for prevalences of cancer screenings in the population. 2) Secondary (a) The point estimates and 95% CIs for prevalences of cancer screenings stratified by age, severity (GAF), and gender. (b) The odds ratio of the GAF adjusted for demographic variables, socioeconomic variables, course of illness, self-rated health status, psychological distress, physician recommendation for receiving cancer screenings, and smoking status. (c) Exploratory analysis of odds ratios of other variables. (d) The associations between disability (WHODAS 2.0) and utilization of cancer screenings assessed by the multiple logistic regression analysis. (e) The cross-tabulated tables of the self-report utilization of cancer screenings versus the utilization of cancer screenings from the record of the municipality. -Smoking behavior 1) Main The point estimate and 95% CI for the proportion of each stages in the process of quitting smoking in the population. 2) Secondary (a) The odds ratio of the GAF adjusted for demographic variables, socioeconomic status, course of illness, self-rated health status, psychological distress, physician recommendation for smoking cessation, and quantity of antipsychotics by the multiple logistic regression analysis. (b) The associations between the heavy smoking index and independent variables by the multiple regression analysis. (c) The proportion of methods of quitting smoking used by past smoker and current smoker. 3) Preliminary longitudinal study The proportions of smoking behaviors in the next year in patients categorized as smokers in the 2016 study. -Validity of WHODAS 2.0 The validity of the Japanese version of WHODAS 2.0 (12-item self-administration version).

Management information
Registered date	2016 Year 08 Month 31 Day
Last modified on	2022 Year 06 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027437