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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011207
Receipt No. R000013137
Scientific Title Cognitive Behavioral Therapy for Anxiety of Cancer Patients - feasibility study
Date of disclosure of the study information 2013/07/17
Last modified on 2018/07/21

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Basic information
Public title Cognitive Behavioral Therapy for Anxiety of Cancer Patients - feasibility study
Acronym Cognitive Behavioral Therapy for Anxiety of Cancer Patients - feasibility study
Scientific Title Cognitive Behavioral Therapy for Anxiety of Cancer Patients - feasibility study
Scientific Title:Acronym Cognitive Behavioral Therapy for Anxiety of Cancer Patients - feasibility study
Region
Japan

Condition
Condition cancer, anxiety
Classification by specialty
Medicine in general Hematology and clinical oncology Surgery in general
Obsterics and gynecology Psychiatry Orthopedics
Urology Radiology Oral surgery
Neurosurgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To test feasibility of cognitive behavioral therapy for anxiety of cancer patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hospital Anxiety and Depression Scale (HADS)
Key secondary outcomes - The Impact of Event Scale-Revised (IES-R)
- Clinical Global Impression (CGI)
- Functional Assessment of Cancer Therapy-General (FACT-G)
- Treatment adherence

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 Brief Cognitive Behavioral Therapy for Anxiety of Cancer Patients (weekly, six-session psychological intervention)
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)age >= 20 years old
2)clinical diagnoses of cancer
3)estimated prognosis >= 3 months
4)>= 4 weeks after cancer diagnosis
5)under treatment in psychiatry/psycho-oncology clinic
6)significant anxiety symptoms, as confirmed by HADS total score of >=11 or HADS anxiety subscale of >= 8
7)submission of written informed consent
Key exclusion criteria 1)severe physical or psychiatric symptoms
2)diffucult to understand Japanese language
3)other clinical decisions
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Asao Ogawa
Organization National Cancer Center East, Japan
Division name Psycho-oncology Division
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7134-7013
Email asogawa@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Fujisawa
Organization National Cancer Center East, Japan
Division name Psycho-oncology Division
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7134-7013
Homepage URL
Email dai_fujisawa@yahoo.co.jp

Sponsor
Institute Psycho-oncology Division, National Cancer Center East, Japan
Institute
Department

Funding Source
Organization Sasagawa Memorial Fund, Takeda Mental Health Fund
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 国立がん研究センター東病院(千葉県)

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 17 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 Enrolling by invitation
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 07 Month 17 Day
Last modified on
2018 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013137

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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