UMIN-CTR Clinical Trial

Basic information
Public title	Intervention by nurse on breast cancer survivors with BMI 25 and more to improve BMI and maintain at a appropriate level.
Acronym	Intervention by nurse on breast cancer survivors with BMI 25 and more to improve BMI and maintain at a appropriate level.
Scientific Title	Intervention by nurse on breast cancer survivors with BMI 25 and more to improve BMI and maintain at a appropriate level.
Scientific Title:Acronym	Intervention by nurse on breast cancer survivors with BMI 25 and more to improve BMI and maintain at a appropriate level.
Region	Japan Asia(except Japan)

Condition
Condition	Breast Cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the feasibility of the intervention in maintaining standard weight and BMI, and also the effect of the exercise in breast cancer patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoint is the rate of the patients who are under BMI25 after one years later from exercise intervention.
Key secondary outcomes	OS,DFS,WHOQOL,BPI,patient background(drinking career, smoking history, menopause, subtype, daily exercise, arthralgia, adherence of medicine)

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	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	1)The intervention will be to have the patients do aerobic exercise 150 minutes per week. 2)The patient record what they ate twice a week. 3)The patients are assessed the BMI, body weight, WHOQOL and BPI at baseline,3,6,9 months, and 12 months later for each patient,
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Less that 4 years after initial treatment. 2)Stage1-3 3)Patients with written informed consent after receiving a full explanation. 4)Over BMI25 5)No physical suffer,no mentalfatigue,doctor and nurses permit to attend the program. 6)Patient who can communicate others and record a diary.
Key exclusion criteria	1)Recurrent patient.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Miwa Arakaki
Organization	Nahanishi Clinic
Division name	Department of Clinical research management office
Zip code
Address	2-1-9 Akamine Naha OKinawa Japan
TEL	098-858-5557
Email	miwamin1531@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Miwa Arakaki
Organization	Nahanishi Clinic
Division name	Department of Clinical research management office
Zip code
Address	2-1-9 Akamine Naha OKinawa Japan
TEL	098-858-5557
Homepage URL
Email	miwamin1531@gmail.com

Sponsor
Institute	Nahanishi Clinic
Institute
Department

Funding Source
Organization	Nahanishi Clinic
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Taiwan Adventist Hospital
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	2017 Year 03 Month 31 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	72
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 01 Month 24 Day
Date of IRB	2017 Year 01 Month 11 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2018 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 01 Month 06 Day

Other
Other related information

Management information
Registered date	2017 Year 03 Month 31 Day
Last modified on	2020 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030774