UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001291 |
|---|---|
| Receipt number | R000001574 |
| Scientific Title | Effectiveness of Problem Solving Therapy for Patients with Breast Cancer - a pilot study |
| Date of disclosure of the study information | 2008/08/04 |
| Last modified on | 2010/08/03 22:33:52 |
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Basic information
Public title
Effectiveness of Problem Solving Therapy for Patients with Breast Cancer - a pilot study
Acronym
Pilot Study of Problem Solving Therapy for Patients with Breast Cancer
Scientific Title
Effectiveness of Problem Solving Therapy for Patients with Breast Cancer - a pilot study
Scientific Title:Acronym
Pilot Study of Problem Solving Therapy for Patients with Breast Cancer
Region
| Japan |
Condition
Condition
Breast Cancer
Major Depression
Adjustment Disorder
Classification by specialty
| Breast surgery | Psychiatry |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To probe effectiveness of problem solving therapy for Japanese patients with breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
Key secondary outcomes
Hospital Anxiety and Depression Scale Rosenberg Selfesteem Scale
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Problem Solving Therapy
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
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
Patients with breast cancer who is comorbid with adjustment disorder or major depression
Written consent was obtained
Key exclusion criteria
1)Hystory of substance abuse, manic episode, or psychotic episode
2)Antisocial personality disorder
3)Acitively suicidal patients
4)Those who are unable to be followed up for six months
5)Past experience of problem solving therapy
6)Organic brain disorder
7)Other sever physicial condition
8)Other any contraindications pointed out by physicians in charge
Target sample size
20
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
TEL
Homepage URL
Sponsor or person
Institute
Keio University Hospital Palliative Care Team
Institute
Department
Personal name
Funding Source
Organization
Keio University Fund for Research Promotion
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
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
Terminated
Date of protocol fixation
| 2008 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
TBA
Management information
Registered date
| 2008 | Year | 08 | Month | 03 | Day |
Last modified on
| 2010 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001574
