UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Psychological response of group interventionin for brast cancer patients
Title of the study (Brief title)	brast cancer patients and group intervention
Region	Japan

Condition
Condition	breast cancer patients
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We study the mood of group intervention for breast cancer patients.
Basic objectives2	Others
Basic objectives -Others	We study the mood and group cohesiveness of group intervention for breast cancer patients.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	mood(baseline, after group intervention, three months after group intervension)
Key secondary outcomes	group cohesiveness

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Yoga and psycho-education(breast cancer group) Once a week, 4 sessions
Interventions/Control_2	Reading books and psycho-education(breast cancer group) Once a week, 4 sessions
Interventions/Control_3	Yoga and psycho-education(healthy adult group) Once a week, 4 sessions
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	new breast cancer over one months after treatments
Key exclusion criteria	other physical disorders mental disorders actively practicing yoga receiving psychotherapy pain in the lower back and neck
Target sample size	60

Research contact person
Name of lead principal investigator	Yumi Iwamitsu
Organization	Kitasato University
Division name	Graduate School of Medical Sciences
Address	1-15-1 Kitasato Minami-ku Sagamihara, Kanagawa, Japan
TEL	042-778-7961
Email	iyumi@kitasato-u.ac.jp

Public contact
Name of contact person	Yumi Iwamitsu
Organization	Kitasato University
Division name	Graduate School of Medical Sciences
Address	1-15-1 Kitasato Minami-ku Sagamihara, Kanagawa, Japan
TEL	042-778-7961
Homepage URL
Email	iyumi@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University
Institute
Department

Funding Source
Organization	Kitasato University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

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	北里大学病院

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 24 Day
Anticipated trial start date	2017 Year 05 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 30 Day
Last modified on	2018 Year 07 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026597