UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023615 |
|---|---|
| Receipt number | 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 08:40:07 |
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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
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
takahashi.tko@gmail.com
Sponsor or person
Institute
Saitama Medical University International Medical Ceter
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027194
