UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023874
Receipt number 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 2022/06/22 08:55:27

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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

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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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