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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017811
Receipt No. R000020515
Scientific Title Effect of a structured group intervention for health promotion among breast cancer survivors with obesity
Date of disclosure of the study information 2015/06/05
Last modified on 2015/06/04

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Basic information
Public title Effect of a structured group intervention for health promotion among breast cancer survivors with obesity
Acronym Shape up ring
Scientific Title Effect of a structured group intervention for health promotion among breast cancer survivors with obesity
Scientific Title:Acronym Shape up ring
Region
Japan

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

Objectives
Narrative objectives1 Obesity is associated with increased risk of breast cancer and it has been linked to poor breast cancer outcomes. Therefore, body weight control will lead to better prognosis. On the other hand, endocrine therapy is a key part in adjuvant treatment of hormone responsive breast cancer. However, therapy is not free from some side effects such as menopausal disorder, arthralgia, weight gain, non-alcoholic fatty liver disease. Furthermore, some studies suggested endocrine therapies particularly aromatase inhibitors (AI) may result in unwanted weight gain.
This study aimed to examine the effect of a structured group intervention for women with obesity and abnormal lipid metabolism during an adjuvant endocrine therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Body weight, body mass index, mid-upper arm circumference, triceps skinfold, liver enzymes (alanine aminotransferase (ALT), aspartate aminotransferase (AST), total cholesterol (CHO) and triglyceride (TG), K6, Self efficacy, Cancer fatigue scale were collected and compared.
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 The subjects were breast cancer survivors with obesity on endocrine therapy. This single-arm pre-post study of combined interventions, which consists 15 minutes nutrition education sessions delivered by a registered dietitian, 30-minutes group health coaching program by a coaching staff, and 45-minutes group aerobic exercise sessions, was performed.
These weekly structured interventions were held 3 times.
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

Not applicable
Gender Female
Key inclusion criteria The subjects were breast cancer survivors with obesity on endocrine therapy.
Key exclusion criteria Patient with cognitive dysfunction
Less than a year after operation
in the middle of chemotherapy
metastatic breast cancer with symptoms
can't exercise because of doctor's orders
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitomi Kitagawa
Organization St. Luke's International Hospital
Division name Department of Breast Surgery
Zip code
Address 10-1 Akashi-cho Chuo-ku Tokyo
TEL 03-3541-5151
Email hiki@luke.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitomi Kitagawa
Organization St. Luke's International Hospital
Division name Department of Breast Surgery
Zip code
Address 10-1 Akashi-cho Chuo-ku Tokyo
TEL 03-3541-5151
Homepage URL
Email hiki@luke.ac.jp

Sponsor
Institute St. Luke's International Hospital
Department of Breast Surgery
Institute
Department

Funding Source
Organization Division of Cancer Survivorship Research, National Cancer Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2015 Year 06 Month 05 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 No longer recruiting
Date of protocol fixation
2014 Year 10 Month 28 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 06 Month 04 Day
Last modified on
2015 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020515

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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