UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001212 |
|---|---|
| Receipt number | R000001480 |
| Scientific Title | Efficacy of intervention program based on cognitive behavior therapy for cancer patients |
| Date of disclosure of the study information | 2008/07/15 |
| Last modified on | 2011/12/29 11:50:13 |
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Basic information
Public title
Efficacy of intervention program based on cognitive behavior therapy for cancer patients
Acronym
Intervention program based on cognitive behaior therapy for cancer patients
Scientific Title
Efficacy of intervention program based on cognitive behavior therapy for cancer patients
Scientific Title:Acronym
Intervention program based on cognitive behaior therapy for cancer patients
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Psychiatry |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Purpose of this study is to exmanine whether psychological intervention that was based on the problem-solving treatment is feasible or not, and to clearfy if the psychological distress decreases more than a usual, natural decrease for the breast cancer patient who completed the adjuvant chemotherapy after the operation and had psychological pain compared with before intervention
Basic objectives2
Others
Basic objectives -Others
Feasibility/ Usability
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. The short-form Supportive Care Needs Survey(SCNS-SF34)
5. Self-efficacy Scale for advanced cancer
6. Mental adjustment to Cancer Scale (MAC)
7. The Concerns About Recurrence Scale (CARS)
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Patients diagnosed as breast cancer clinically, histologically, or pathologically
2. Patients who has received the adjuvant chemotherapy or the adjuvant hormon therapy after operation or who has received the neo-adjuvant chemotherapy before operation
3. Patients who has explained about their diagonosis
4. Age older than 20 years and younger 70 years
5. ECOG PS was 0 or 1, and has abillity to go to the hospital and to do slightl physical activity
6. Patients who has met with following criterion based on "Distress and Impact Thermometer": Distress score was above 3 and Impact score was above 1.
Key exclusion criteria
1. Patients diagnosed that the psychiatric treatment will be necessary by phsician, such as depressive disorder with suicidal thoughts or wishes.
2. Patients with evidence of cognitive impairment such as dementia and delirium or mental illness such as schizophrenia
3. Patients who take parmacotherapy by antipsychotics
4. Patients with evidence of cognitive function impairment
5. Patients with difficulty literacy of Japanese
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 | 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
Homepage URL
Sponsor or person
Institute
Osaka University
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 | 07 | Month | 15 | 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 | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | 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
| 2011 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001480
