UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027546 |
|---|---|
| Receipt number | R000026597 |
| Scientific Title | Psychological response of group interventionin for brast cancer patients |
| Date of disclosure of the study information | 2017/05/30 |
| Last modified on | 2018/07/28 12:03:06 |
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Basic information
Public title
Psychological response of group interventionin for brast cancer patients
Acronym
brast cancer patients and group intervention
Scientific Title
Psychological response of group interventionin for brast cancer patients
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yumi Iwamitsu |
Organization
Kitasato University
Division name
Graduate School of Medical Sciences
Zip code
Address
1-15-1 Kitasato Minami-ku Sagamihara, Kanagawa, Japan
TEL
042-778-7961
iyumi@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumi Iwamitsu |
Organization
Kitasato University
Division name
Graduate School of Medical Sciences
Zip code
Address
1-15-1 Kitasato Minami-ku Sagamihara, Kanagawa, Japan
TEL
042-778-7961
Homepage URL
iyumi@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 24 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026597
