UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002303
Receipt number R000002767
Scientific Title Development of walking exercise program for fatigue management of breast cancer patient
Date of disclosure of the study information 2014/02/26
Last modified on 2009/08/06 15:34:47

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Basic information

Public title

Development of walking exercise program for fatigue management of breast cancer patient

Acronym

Development of walking exercise program for fatigue management of breast cancer patient

Scientific Title

Development of walking exercise program for fatigue management of breast cancer patient

Scientific Title:Acronym

Development of walking exercise program for fatigue management of breast cancer patient

Region

Japan


Condition

Condition

Breast Cancer

Classification by specialty

Nursing

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to development of the walking exercise program for fatigue management which is based on The Integrated Approach to Symptom Management of Breast Cancer Patient receiving adjuvant chemotherapy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

SF-36
Cancer Fatigue Scale
NRS
revel of selfcare

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

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

exercise

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

over 20 years old
Breast Cancer
recieving adjuvant chemotherapy

Key exclusion criteria

contraindication exercise

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Satoko Miyawaki

Organization

Kochi Women University

Division name

master

Zip code


Address

Kochi-shi Ike

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kochi Women University

Division name

master

Zip code


Address


TEL

090-4894-7649

Homepage URL


Email



Sponsor or person

Institute

Satoko Miyawaki

Institute

Department

Personal name



Funding Source

Organization

Non proit foundation YUMI ZAIDAN

Organization

Division

Category of Funding Organization

Non profit foundation

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

2014 Year 02 Month 26 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

Preinitiation

Date of protocol fixation

2009 Year 08 Month 10 Day

Date of IRB


Anticipated trial start date

2009 Year 08 Month 01 Day

Last follow-up date

2009 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 08 Month 06 Day

Last modified on

2009 Year 08 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002767


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name