UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035837
Receipt number R000040823
Scientific Title Effects of a short term psychotherapy in postoperative breast cancer patients: an exploratory study
Date of disclosure of the study information 2019/02/11
Last modified on 2019/06/09 15:05:09

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Basic information

Public title

Effects of a short term psychotherapy in postoperative breast cancer patients: an exploratory study

Acronym

EBICe Study

Scientific Title

Effects of a short term 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 short term 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":
- A personal interview of one to three hours per time
- One- to three-time interviews for one participant

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

Name of lead principal investigator

1st name Jun
Middle name
Last name Nagano

Organization

Center for Health Sciences and Counseling, Kyushu University

Division name

Division of Health Sciences

Zip code

819-0395

Address

744 Motooka, Nishiku, Fukuoka

TEL

092-802-5118

Email

nagano@chc.kyushu-u.ac.jp


Public contact

Name of contact person

1st name Jun
Middle name
Last name Nagano

Organization

Center for Health Sciences and Counseling, Kyushu University

Division name

Division of Health Sciences

Zip code

819-0395

Address

744 Motooka, Nishiku, Fukuoka

TEL

092-802-5118

Homepage URL


Email

nagano@chc.kyushu-u.ac.jp


Sponsor or person

Institute

Kyushu University

Institute

Department

Personal name



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

Kyushu University Hospital Clinical Studies Ethics Commitee

Address

3-1-1 Maidashi, Higashiku, Fukuoka

Tel

092-642-5082

Email

byskenkyu@jimu.kyushu-u.ac.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



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

22

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

No longer recruiting

Date of protocol fixation

2018 Year 11 Month 28 Day

Date of IRB

2019 Year 01 Month 08 Day

Anticipated trial start date

2019 Year 02 Month 05 Day

Last follow-up date

2020 Year 09 Month 30 Day

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 06 Month 09 Day



Link to view the page

Value
https://center6.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