UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of collecting patient -generated health data using mobile health
Title of the study (Brief title)	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	Kanako Azuma
Organization	Tokyo medical University of Tokyo
Division name	Department of Pharmacy
Address	160-0022, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL	03-3342-6111
Email	azuma-k@tokyo-med.ac.jp

Public contact
Name of contact person	Tempei Miyaji
Organization	The University of Tokyo
Division name	Department of Clinical Trial Data Management, Graduate School of Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000031579