UMIN-CTR Clinical Trial

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 Asao Middle name Last name Ogawa
Organization	National Cancer Center East, Japan
Division name	Psycho-oncology Division
Zip code	277-8577
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 Daisuke Middle name Last name Fujisawa
Organization	National Cancer Center East, Japan
Division name	Psycho-oncology Division
Zip code	277-8577
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	IRB, National Cancer Center Japan
Address	5-1-1 Tsukiji, Chuoh-ku, Tokyo
Tel	03-3542-2511
Email	NCC_IRBoffice@ml.res.ncc.go.jp

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	Terminated
Date of protocol fixation	2013 Year 04 Month 01 Day
Date of IRB	2013 Year 04 Month 11 Day
Anticipated trial start date	2013 Year 04 Month 19 Day
Last follow-up date	2015 Year 03 Month 31 Day
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	2022 Year 01 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013137