UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001290 |
|---|---|
| Receipt number | 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 13:12:26 |
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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
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
Sponsor or person
Institute
Keio University Hospital Palliative Care Team
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001573
