UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036017 |
|---|---|
| Receipt number | 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 | 2022/06/22 12:22:09 |
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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
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
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
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
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
https://doi.org/10.17632/r7n83753gy.1
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1111/acps.13348 (Fujiwara et al. Acta Psychiatrica Scandinavica 2021 )
Number of participants that the trial has enrolled
172
Results
Please see the above paper
Results date posted
| 2021 | Year | 08 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 08 | Month | 03 | Day |
Baseline Characteristics
Please see the above paper
Participant flow
Please see the above paper
Adverse events
Please see the above paper
Outcome measures
Please see the above paper
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
Completed
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
| 2020 | Year | 05 | Month | 29 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 08 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 26 | 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=R000041015
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/11/02 | Study Protocol and Statistical Analysis Plan.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
