UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026806 |
|---|---|
| Receipt number | R000030774 |
| Scientific Title | Intervention by nurse on breast cancer survivors with BMI 25 and more to improve BMI and maintain at a appropriate level. |
| Date of disclosure of the study information | 2017/03/31 |
| Last modified on | 2020/04/18 17:25:13 |
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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
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
miwamin1531@gmail.com
Sponsor or person
Institute
Nahanishi Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030774
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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