UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008988
Receipt number R000010340
Scientific Title Telephonic consultations during outpatient chemotherapy
Date of disclosure of the study information 2012/10/01
Last modified on 2015/06/04 11:17:29

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Basic information

Public title

Telephonic consultations during outpatient chemotherapy

Acronym

Telecare for cancer patient

Scientific Title

Telephonic consultations during outpatient chemotherapy

Scientific Title:Acronym

Telecare for cancer patient

Region

Japan


Condition

Condition

Cancer

Classification by specialty

Medicine in general Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the operational state of hotline service at NCCH

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Association with AE and outcome

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

patients with using telecare support

Key exclusion criteria

none

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shunsuke Kondo

Organization

National Cancer Center Hospital

Division name

Internal medicine

Zip code


Address

5-1-1, Tsukiji, Chuo-ku

TEL

03-3542-2511

Email

shkondo@ncc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shunsuke Kondo

Organization

National Cancer Center Hospital

Division name

Internal medicine

Zip code


Address

5-1-1, Tsukiji, Chuoku, Tokyo

TEL

03-3542-2511

Homepage URL


Email

shkondo@ncc.go.jp


Sponsor or person

Institute

Shunsuke Kondo

Institute

Department

Personal name



Funding Source

Organization

National Cancer Center Research and Development Fund (23-A-14)

Organization

Division

Category of Funding Organization

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



Other administrative information

Date of disclosure of the study information

2012 Year 10 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://jsmo2012.umin.jp/program_26.pdf

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

2012 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 10 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2013 Year 11 Month 01 Day


Other

Other related information

Association between AE and endpoint of chemotherapy


Management information

Registered date

2012 Year 09 Month 26 Day

Last modified on

2015 Year 06 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010340


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name