UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of the training program for certified oncology nusrses to manage psychiatric symptoms in cancer patients: a randomized controlled trial
Title of the study (Brief title)	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	Okuyama Toru
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Psychiatry and Cognitive-Behavioral Medicine
Address	Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL	052-853-8271
Email	kokoro.no.care.program@gmail.com

Public contact
Name of contact person	Kubota Yosuke
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Psychiatry and Cognitive-Behavioral Medicine
Address	Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL	0561-853-8271
Homepage URL
Email	kokoro.no.care.program@gmail.com

Sponsor
Institute	Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences
Institute
Department

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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 07 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009869