UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008559 |
|---|---|
| Receipt number | R000009869 |
| Scientific Title | Efficacy of the training program for certified oncology nusrses to manage psychiatric symptoms in cancer patients: a randomized controlled trial |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2016/08/01 12:36:23 |
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Basic information
Public title
Efficacy of the training program for certified oncology nusrses to manage psychiatric symptoms in cancer patients: a randomized controlled trial
Acronym
The training program for certified oncology nusrses to manage psychiatric symptoms in cancer patients
Scientific Title
Efficacy of the training program for certified oncology nusrses to manage psychiatric symptoms in cancer patients: a randomized controlled trial
Scientific Title:Acronym
The training program for certified oncology nusrses to manage psychiatric symptoms in cancer patients
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Psychiatry | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study is to explore the efficacy of the training program for certified oncology nusrses to manage psychiatric symptoms in cancer patients by a randomized controlled trial
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Confidence in the provision of psychosocial care for cancer patient, Knowledge of concerning with psycho-oncology, Attitudes Toward Caring for Patients Meaninglessness scale : willingness to help, helplessness, positive appraisal
Key secondary outcomes
Maslach Burnout Inventory, Nursing Job Storessor Scale, job satisfaction, the tendency of separetion from service
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention:12h(2days, 6 hours per day) educational program.The program included six important areas regarding psychiatric care fro cancer patients; overview of psycho-oncology, depression, delirium, suicidal thought, insomnia, and geriatric problems.
Interventions/Control_2
Waiting List control
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
1, The certified nurse or certified nurse specialist as follows : in Cancer Chomotherapy Nursing, in Palliative Care, in Cancer Pain Management Nursing, in Breast Cancer Nursing, in Radiation Therapy Nursing, in Cancer Nursing, in Psychiatric Mental Health Nursing.
2, Currently working as a nurse
3, Working in Aichi Prefecture
Key exclusion criteria
None
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Okuyama Toru |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code
Address
Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
052-853-8271
kokoro.no.care.program@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kubota Yosuke |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code
Address
Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
0561-853-8271
Homepage URL
kokoro.no.care.program@gmail.com
Sponsor or person
Institute
Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Aichi Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
名古屋市立大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | 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
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
| 2012 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 29 | Day |
Last modified on
| 2016 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009869
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
