UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033849 |
|---|---|
| Receipt number | 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 | 2020/02/20 18:56:51 |
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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
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
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
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
13
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
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2018 | Year | 08 | Month | 21 | Day |
Last modified on
| 2020 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.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 |
