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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035837
Receipt No. R000040823
Scientific Title Effects of a brief psychotherapy in postoperative breast cancer patients: an exploratory study
Date of disclosure of the study information 2019/02/11
Last modified on 2019/02/11

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Basic information
Public title Effects of a brief psychotherapy in postoperative breast cancer patients: an exploratory study
Acronym EBICe Study
Scientific Title Effects of a brief psychotherapy in postoperative breast cancer patients: an exploratory study
Scientific Title:Acronym EBICe Study
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Hematology and clinical oncology Psychosomatic Internal Medicine Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To obtain preliminary data to design a randomized controlled trial examining the effects of a brief psychotherapy "autonomy training" in postoperative breast cancer patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Neuroendocrinoimmunological biomarkers, oncological markers, and behavioral indices
Key secondary outcomes

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 Psychotherapy "Autonomy Training"
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) Age from 20 to 69 years
2) Reccurence free two years of the first operation
3) Competence of smooth communication in Japanese and answering self-administered questionnaires
4) Give signed consent
Key exclusion criteria 1) History of other neoplasms
2) History of corticosteroid therapy within one month
3) Diseases possibly affect the immune system
4) Other conditions doctor judges innapropriate
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Jun Nagano
Organization Center for Health Sciences and Counseling, Kyushu University
Division name Division of Health Sciences
Zip code
Address 6-1 Kasuga Park, Kasuga, Fukuoka
TEL 092-583-7685
Email jun@artsci.kyushu-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Jun Nagano
Organization Center for Health Sciences and Counseling, Kyushu University
Division name Division of Health Sciences
Zip code
Address 6-1 Kasuga Park, Kasuga, Fukuoka
TEL 092-583-7685
Homepage URL
Email jun@artsci.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 11 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 Open public recruiting
Date of protocol fixation
2018 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 05 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
2019 Year 02 Month 11 Day
Last modified on
2019 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040823

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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