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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023615
Receipt No. R000027194
Scientific Title Quantitative assessment of cancer patients physical activity using pedometer
Date of disclosure of the study information 2016/08/15
Last modified on 2017/08/15

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Basic information
Public title Quantitative assessment of cancer patients physical activity using pedometer
Acronym Quantitative assessment of cancer patients physical activity using pedometer
Scientific Title Quantitative assessment of cancer patients physical activity using pedometer
Scientific Title:Acronym Quantitative assessment of cancer patients physical activity using pedometer
Region
Japan

Condition
Condition cancer patients
Classification by specialty
Hematology and clinical oncology Surgery in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess physical activity of cancer patients, we use a pediometer which can measure number of steps, Mets, and calorie consumption. We conduct a clinical study to assess whether use of pedometer could predict early adverse effect or body condition after the start of chemotherapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To assess conrrelation between physical activity measured by pedometer and grading score of adverse effect after chemotherapy
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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Use of pedometer
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
18 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria 1) patients who have or had diagnosed as cancer
2) Patients who can do self report about their condition and use a pedometer
Key exclusion criteria Patients who can not do above
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Takahashi
Organization Saitama Medical University International Medical Ceter
Division name Dept of Palliative medicine, Dept of Breast Oncology
Zip code
Address 1397-1 Yamane, Hidaka, Saitama
TEL 0429844111
Email takahashi.tko@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takao Takahashi
Organization Saitama Medical University International Medical Ceter
Division name Dept of Palliative medicine, Dept of Breast Oncology
Zip code
Address 1397-1 Yamane, Hidaka, Saitama
TEL 0429844111
Homepage URL
Email takahashi.tko@gmail.com

Sponsor
Institute Saitama Medical University International Medical Ceter
Institute
Department

Funding Source
Organization Saitama Medical University International Medical Ceter
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 08 Month 15 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 Enrolling by invitation
Date of protocol fixation
2016 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 15 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
2016 Year 08 Month 13 Day
Last modified on
2017 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027194

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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