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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001212
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Osaka University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001480

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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