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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033849
Receipt No. R000037895
Scientific Title A feasibility open trial of the case management to encourage uptake of cancer screening for people with schizophrenia in psychiatric outpatient clinics
Date of disclosure of the study information 2018/10/01
Last modified on 2019/02/20

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Basic information
Public title A feasibility open trial of the case management to encourage uptake of cancer screening for people with schizophrenia in psychiatric outpatient clinics
Acronym A feasibility study to encourage uptake of cancer screening for people with schizophrenia
Scientific Title A feasibility open trial of the case management to encourage uptake of cancer screening for people with schizophrenia in psychiatric outpatient clinics
Scientific Title:Acronym A feasibility study to encourage uptake of cancer screening for people with schizophrenia
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 feasibility and preliminary efficacy of the case management to encourage uptake of cancer screening for people with schizophrenia in psychiatric outpatient clinics.
Basic objectives2 Others
Basic objectives -Others Feasibility
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The proportion of the participants who completed the intervention
Key secondary outcomes Description about the intervention implemented for each participant

Description about issue in implementing the intervention

Self-reported uptake of colorectal cancer screening and other cancer screenings which are recommended for participants

Municipal records of uptake of colorectal cancer screening and other cancer screenings which are recommended for participants

Description about reasons of uptake or non-uptake of colorectal cancer screening and detailed examination recommended after screening

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Case management to encourage uptake of cancer screening

Usual cancer screening promotion conducted in community setting by Okayama city
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Outpatients diagnosed with schizophrenia or schizoaffective disorder according to the DSM-5 criteria by their primary psychiatrist

2) Patients who visited the hospital of the study site twice or more in the last 6 months

3) Patients aged 40 years or more

4) Patients who live in Okayama city and who are enrolled in the National Health Insurance or Public Assistance systems

5) Patients who understand and agree with the enrollment of this study with IC form, or patients whose proxies consents to their participation in the study
Key exclusion criteria 1) Patients with a history of colorectal cancer

2) Patients who have already received colorectal cancer screening in the 2018 fiscal year

3) Patients who plan to move out of Okayama city within 6 months

4) Patients who are judged by their primary psychiatrists as having a risk to deteriorate their symptoms by participating the study

5) Patients who are judged as having insufficient ability to judge by their primary psychiatrist, and who are not accompanied by their proxies in visiting clinics

6) Patients who are judged as not appropriate for participation by the research director and research investigators
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihito Yamada
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science
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
Name of contact person
1st name
Middle name
Last name Masaki Fujiwara
Organization Okayama University Hospital
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 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 Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 岡山県精神科医療センター(岡山県)
慈圭病院(岡山県)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 No longer recruiting
Date of protocol fixation
2018 Year 08 Month 21 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 21 Day
Last modified on
2019 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037895

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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