UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027575 |
|---|---|
| Receipt number | R000031579 |
| Scientific Title | Feasibility study of collecting patient -generated health data using mobile health |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2018/06/01 09:32:37 |
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Basic information
Public title
Feasibility study of collecting patient -generated health data using mobile health
Acronym
Feasibility study of collecting patient -generated health data using mobile health
Scientific Title
Feasibility study of collecting patient -generated health data using mobile health
Scientific Title:Acronym
Feasibility study of collecting patient -generated health data using mobile health
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate a feasibility of the use of mobile Health by cancer patients in clinical research setting.
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Adherence of Wearable-device
Key secondary outcomes
Change of Brief Fatigue Inventory scores at day 29 from baseline scores.
MD Anderson Symptom Inventory
CTCAE ver.4
Proportion of self-setting of wearable device.
Relation on sleep between records from wearable device and patient-reported 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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Patients are asked to wear Garmin Vivofit 3 from the day before of the initiation of chemotherapy until 28 days after the initiation of chemotherapy. The removal of the device is depended on patient's decision. After 29 days of main observational period, patients are asked to keep wearing the device for another 5 months as a follow-up. Patients can decide to un-wear the device for anytime in a follow-up period.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age of 20 to 75
2. Diagnosed as Cancer
3. Plan to receive a first-line chemotherapy
4. Inpatients at the time of enrollment
5. Able to use own smartphone
6. Able to understand and answer in Japanese
7. Written informed consent
Key exclusion criteria
1. Clinically severe cognitive deficiency and memory disorder
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kanako Azuma |
Organization
Tokyo medical University of Tokyo
Division name
Department of Pharmacy
Zip code
Address
160-0022, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-3342-6111
azuma-k@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tempei Miyaji |
Organization
The University of Tokyo
Division name
Department of Clinical Trial Data Management, Graduate School of Medicine
Zip code
Address
7-3-1 Hongo,Bunkyo-ku,Tokyo,13-8655,Japan
TEL
03-5800-9086
Homepage URL
tmiyaji@m.u-tokyo.ac.jp
Sponsor or person
Institute
Tokyo Medical University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University of Tokyo
Keiyu Hospital
The University of Tokyo
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
東京医科大学病院（東京都）、けいゆう病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | 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
| 2017 | Year | 05 | Month | 31 | Day |
Last modified on
| 2018 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031579
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
