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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000023874
Receipt No. R000027437
Scientific Title A cross-sectional study of cancer screening behavior and smoking behavior among people with serious mental illness.
Date of disclosure of the study information 2016/09/01
Last modified on 2018/03/05

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

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

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
Publication of results Published

Result
URL related to results and publications http://onlinelibrary.wiley.com/doi/10.1111/pcn.12554/full
Number of participants that the trial has enrolled
Results
http://onlinelibrary.wiley.com/doi/10.1111/pcn.12554/full
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2015 Year 12 Month 15 Day
Date of IRB
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
2018 Year 03 Month 05 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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