UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024873
Receipt number 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 14:49:50

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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 or person

Institute

Saitama Medical University, International Medical Center

Institute

Department

Personal name



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

Value
https://center6.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