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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036017
Receipt No. R000041015
Scientific Title A randomized Controlled trial of the Case management to Encourage participation in cancer Screening for people with Schizophrenia in psychiatric outpatient clinics
Date of disclosure of the study information 2019/06/01
Last modified on 2019/09/11

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Basic information
Public title A randomized Controlled trial of the Case management to Encourage participation in cancer Screening for people with Schizophrenia in psychiatric outpatient clinics
Acronym ACCESS
Scientific Title A randomized Controlled trial of the Case management to Encourage participation in cancer Screening for people with Schizophrenia in psychiatric outpatient clinics
Scientific Title:Acronym ACCESS
Region
Japan

Condition
Condition Schizophrenia
(including Schizoaffective disorder)
Classification by specialty
Psychiatry
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study aims to investigate the efficacy of the case management to encourage participation in cancer screening for people with schizophrenia in psychiatric outpatient clinics.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes The proportion of the participants who received municipal colorectal cancer screening in the fiscal year 2019
Key secondary outcomes The proportion of the participants who received other municipal cancer screenings in the fiscal year 2019 which are recommended for participants

Reasons of participation or non-participation in colorectal cancer screening and detailed examination recommended after screening

Participant's comments on receiving the intervention and useful elements of the intervention

Case manager's comments on useful elements and practical issues of the intervention

Required time for the intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group

Case management to encourage participation in cancer screening will be implemented.
Usual cancer screening promotion conducted in community setting by Okayama city will be implemented regardless of this study.
Interventions/Control_2 Control group

Usual cancer screening promotion conducted in community setting by Okayama city will be implemented regardless of this study.
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 participated in colorectal cancer screening in the 2018 fiscal year

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

4) Patients who lived in an institution where residents are supported for receiving cancer screenings

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

6) 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
Target sample size 172

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 Science
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 Hospital
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 Research for Promotion of Cancer Control Programs
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 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 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
2019 Year 06 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 The datasets generated and/or analyzed during this study will not be publicly available because of the terms of consent to which the participants will agree, but may be available from the corresponding author on reasonable request.
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2019 Year 02 Month 25 Day
Date of IRB
2019 Year 04 Month 23 Day
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 26 Day
Last modified on
2019 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041015

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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