UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001211 |
|---|---|
| Receipt number | R000001479 |
| Scientific Title | development of group intervention program for cancer patients based on cognitive behavior therapy |
| Date of disclosure of the study information | 2008/06/30 |
| Last modified on | 2012/12/26 14:09:04 |
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Basic information
Public title
development of group intervention program for cancer patients based on cognitive behavior therapy
Acronym
group intervention program for cancer patients based on cognitive behaior therapy
Scientific Title
development of group intervention program for cancer patients based on cognitive behavior therapy
Scientific Title:Acronym
group intervention program for cancer patients based on cognitive behaior therapy
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Psychiatry |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Purposes of this study are to exmanine whether the group intervention program based on the problem solving treatment for the cancer patient is feasible or not, and to clearfy whether the psychological distress is ameliorated or not by the intervention.
Basic objectives2
Others
Basic objectives -Others
Feasibility/ Effectiveness
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Japanese version of Hospital Anxiety and Depression Scale(HADS)
Key secondary outcomes
1. Japanese version of Hospital Anxiety and Depression Scale(HADS)
2. EORTC-QLQ-C30
3.Brief Cancer-related Worry Inventory
4. Self-efficacy Scale for advanced cancer
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
Educational,Counseling,Training
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed as cancer clinically, histologically, or pathologically
2. Patients who has been disclosed of their cancer diagonosis
3. Age of older than 20 years
4. ECOG PS of 0 or 1, and being able to visit outpatient clinic and physically functioned quite well
Key exclusion criteria
1. Patients judged by their physicians that the psychiatric treatment is necessary such as depressive disorder with suicidal ideation.
2. Patients with cognitive impairment such as dementia and delirium or mental illness such as schizophrenia
3. Patients taking antipsychotics
4. Illiteracy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Hirai |
Organization
Graduate School of Medicine, Faculty of Medicine
Division name
Department of Complementalry and Alternative Medicine
Zip code
Address
Yamadaoka 2-2, Suita City, 565-0871, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shokoji Masako |
Organization
Toyonaka Municipal Hospiral
Division name
Department of Psychiatry
Zip code
Address
Shibahara-Cho 4-14-1, Toyonaka City, 560-8565, JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Toyonaka Municipal Hospiral
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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 | 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
| 2008 | Year | 02 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 06 | Month | 26 | Day |
Last modified on
| 2012 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001479
