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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001290
Receipt No. R000001573
Scientific Title Screening of Psychological Distress among patients with breast cancer, using Distress and Impact Theremometer
Date of disclosure of the study information 2008/08/04
Last modified on 2009/02/03

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Basic information
Public title Screening of Psychological Distress among patients with breast cancer, using Distress and Impact Theremometer
Acronym Psychological Screening among Breast Cancer Patient using Distress and Impact Thermometer
Scientific Title Screening of Psychological Distress among patients with breast cancer, using Distress and Impact Theremometer
Scientific Title:Acronym Psychological Screening among Breast Cancer Patient using Distress and Impact Thermometer
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Breast surgery Psychiatry
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine among patients with breast cancer whether usage of Distress and Impact Thermometer facilitates better screening of psychological distress and earlier referral to mental health professionals.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Referral rate to mental health professionals
Key secondary outcomes Score on Distress and Impact Thermometer(DIT), Fidelity of DIT, Prevalence of adjustment disoder and major depression

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All the patients in breast cancer clinic
Key exclusion criteria Those considered by the physycian in charge as inappropriate to be enrolled in the study
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Fujisawa
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo
TEL 03-5363-3829
Email

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Fujisawa
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo
TEL 03-5363-3829
Homepage URL
Email

Sponsor
Institute Keio University Hospital Palliative Care Team
Institute
Department

Funding Source
Organization Ministry of Health and Labor Fund for Cancer Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor National Cancer Center Psychiatry Division
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 08 Month 04 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
TBA
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
2008 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
2009 Year 03 Month 01 Day
Date trial data considered complete
2009 Year 03 Month 01 Day
Date analysis concluded
2009 Year 04 Month 01 Day

Other
Other related information Approximately 20% of the participants were psychologically distressed.

Management information
Registered date
2008 Year 08 Month 03 Day
Last modified on
2009 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001573

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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