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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027575
Receipt No. 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

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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
Last 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
Email azuma-k@tokyo-med.ac.jp

Public contact
1st 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
Email tmiyaji@m.u-tokyo.ac.jp

Sponsor
Institute Tokyo Medical University of Tokyo
Institute
Department

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
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 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
URL(English) https://upload.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
Registered date File name


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