UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017811 |
|---|---|
| Receipt number | 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 13:18:32 |
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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
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
hiki@luke.ac.jp
Sponsor or person
Institute
St. Luke's International Hospital
Department of Breast Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020515
