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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024873
Receipt No. R000028628
Scientific Title A feasibility study to validate the utility of Web-based supportive care application program for tablet terminator regarding patient-reported outcome
Date of disclosure of the study information 2016/11/18
Last modified on 2019/05/24

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Basic information
Public title A feasibility study to validate the utility of Web-based supportive care application program for tablet terminator regarding patient-reported outcome
Acronym A feasibility study to validate the utility of Web-based supportive care application program for tablet terminator
Scientific Title A feasibility study to validate the utility of Web-based supportive care application program for tablet terminator regarding patient-reported outcome
Scientific Title:Acronym A feasibility study to validate the utility of Web-based supportive care application program for tablet terminator
Region
Japan

Condition
Condition Cancer
Classification by specialty
Medicine in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A pilot study to validate utility of web-based application program for cancer patients who recieve chemotherapy/care and report adverse events
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To validate whether cancer patients using application can report adverse events and physical and emotional conditions or not
Key secondary outcomes To compare the results of application-based reports and QOL reports

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 considered as a block.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Using a tablet terminator
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.Cancer patients who will recieve treatment and/or care
2.Patients who can use a tablet terminator
3.Patinet who understand the content of the study and agree to the study participation
Key exclusion criteria Patients whom a attending doctor judge as uneligible.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Saeki
Middle name
Last name Toshiaki
Organization Saitama Medical University, International Medical Center
Division name Department of breast oncology
Zip code 3501297
Address 1397-1 Yamane, Hidaka, Saitama
TEL 81-42-984-4670
Email tsaeki@saitama-med.ac.jp

Public contact
Name of contact person
1st name Maki
Middle name
Last name Todo
Organization Saitama Medical University, International Medical Center
Division name Department of pharmacy
Zip code 350-1298
Address 1397-1 Yamane, Hidaka, Saitama
TEL 81-42-984-4670
Homepage URL
Email syueda@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University, International Medical Center
Institute
Department

Funding Source
Organization Saitama Medical University, International Medical Center
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 Saitama Medical University, International Medical Center
Address 13971Yamane,Hidaka,Saitama
Tel 81-984-4523
Email chikens@saitama-med.ac.jp

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 11 Month 18 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 Open public recruiting
Date of protocol fixation
2016 Year 11 Month 18 Day
Date of IRB
2016 Year 11 Month 17 Day
Anticipated trial start date
2016 Year 11 Month 18 Day
Last follow-up date
2030 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 17 Day
Last modified on
2019 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028628

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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