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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001178
Receipt No. R000001092
Scientific Title The probability of nurse-screening system to evaluate psyhological distress of outpatients during chemotherapy against cancer
Date of disclosure of the study information 2008/06/30
Last modified on 2010/12/07

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Basic information
Public title The probability of nurse-screening system to evaluate psyhological distress of outpatients during chemotherapy against cancer
Acronym The screening system to evaluate psyhological distress of outpatients during chemotherapy against cancer
Scientific Title The probability of nurse-screening system to evaluate psyhological distress of outpatients during chemotherapy against cancer
Scientific Title:Acronym The screening system to evaluate psyhological distress of outpatients during chemotherapy against cancer
Region
Japan

Condition
Condition cancer
Classification by specialty
Psychosomatic Internal Medicine Psychiatry Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To develop the early treatment system for psychological symptoms of outpatients with cancer during their chemotherapy, the study is planned to evaluate the probability of screening system by nurse to assess psychological distress using the distress and impact thermometer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Number of cases who are performed interviewing assessments by psychiatrists.
Key secondary outcomes

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 Diagnosis
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 The distress and impact thermometer
Interview by psychiatrist
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Japanese,
Outpattients with cancer,
Who are performed chemotherapy against cancer from June/1/2007 to November/30/2007 in the hiroshima university hospital,
Who are capable of verbal communication,
Who are able to agree this research
Key exclusion criteria Disable to answer the distress and impact thermometer, due to physical and mental condition. (e.g. dementia, delirium, blind)
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Kobayakawa
Organization Hiroshima University Hospital
Division name Division of Psychiatry
Zip code
Address 1-2-3 Kasumi Minamiku Hiroshima, Japan
TEL 082-257-5207
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hiroshima University Hospital
Division name Division of Psychiatry
Zip code
Address
TEL 082-257-5207
Homepage URL
Email

Sponsor
Institute Hiroshima University Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2008 Year 06 Month 30 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
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
2007 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2007 Year 07 Month 01 Day
Last follow-up date
2008 Year 12 Month 01 Day
Date of closure to data entry
2008 Year 12 Month 01 Day
Date trial data considered complete
2008 Year 12 Month 01 Day
Date analysis concluded
2009 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 06 Month 06 Day
Last modified on
2010 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001092

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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