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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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