UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036034 |
|---|---|
| Receipt number | R000040828 |
| Scientific Title | Development of recommendation method for access to mental health services for cancer patients: A pilot study |
| Date of disclosure of the study information | 2019/02/28 |
| Last modified on | 2020/02/22 14:52:03 |
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Basic information
Public title
Development of recommendation method for access to mental health services for cancer patients: A pilot study
Acronym
Development of recommendation method for access to mental health services for cancer patients: A pilot study
Scientific Title
Development of recommendation method for access to mental health services for cancer patients: A pilot study
Scientific Title:Acronym
Development of recommendation method for access to mental health services for cancer patients: A pilot study
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Whether cancer patients who are mentally ill take psychiatric examinations by posters, leaflets and brochures?
Basic objectives2
Others
Basic objectives -Others
Whether cancer patients who are mentally ill consult Cancer Information and Support Centers by posters, leaflets and brochures?
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether the number of cancer patients with a diagnosis of ICD-10 F3 and F4 take psychiatric examinations during recommendation for mental health care increases compared to those during no recommendation.
Whether the number of cancer patients with a diagnosis of ICD-10 F3 and F4 consult psychiatric examinations during recommendation for mental health care increases compared to those during no recommendation.
Key secondary outcomes
Whether the number of cancer patients with a diagnosis of ICD-10 F3 and F4 consult psychiatric examinations during recommendation for mental health care increases compared to those during no recommendation.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
First-visit cancer patients to Yokohama City University Medical Center during May 1st of 2018 to May 31st and 201st March 1st to May 31st.
Key exclusion criteria
Those who are not cancer patients.
Target sample size
680
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Inoue |
Organization
Yokohama City University Medical Center
Division name
Psychiatric center
Zip code
232-0024
Address
4-57 Urafune, Minami-ku, Yokohama 232-0024 Japan
TEL
045-261-5656
kinoue@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Inoue |
Organization
Yokohama City University Medical Center
Division name
Psychiatric center
Zip code
232-0024
Address
4-57 Urafune, Minami-ku, Yokohama 232-0024 Japan
TEL
045-261-5656
Homepage URL
kinoue@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor 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
Yokohama City University Medical Center
Address
4-57 Urafune, Minami-ku, Yokohama 232-0024 Japan
Tel
045-261-5656
kinoue@yokohama-cu.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
横浜市立大学附属市民総合医療センター
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 28 | 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
1333
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
| 2019 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 01 | Month | 15 | Day |
Other
Other related information
Count the number of patients by DPC data and clinical charts.
Management information
Registered date
| 2019 | Year | 02 | Month | 28 | Day |
Last modified on
| 2020 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040828
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
