UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021967
Receipt number R000025325
Scientific Title Psychological impact of learning and exchange support to the use of IT has on pediatric cancer patients
Date of disclosure of the study information 2016/05/18
Last modified on 2016/04/18 16:37:08

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Basic information

Public title

Psychological impact of learning and exchange support to the use of IT has on pediatric cancer patients

Acronym

Psychological impact of learning and exchange support to the use of IT has on pediatric cancer patients

Scientific Title

Psychological impact of learning and exchange support to the use of IT has on pediatric cancer patients

Scientific Title:Acronym

Psychological impact of learning and exchange support to the use of IT has on pediatric cancer patients

Region

Japan


Condition

Condition

Childhood cancer

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Two-way learning support and exchanges support using IT to verify whether it is beneficial to compensate for exchange and learning and others.

Basic objectives2

Others

Basic objectives -Others

Two-way learning support and exchanges support using IT to verify whether it is beneficial to compensate for exchange and learning and others.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Score of the questionnaire

Key secondary outcomes

Score of the questionnaire


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Lending the tablet terminal, make the learning support using IT. Time of learning exchanges support activities is two hours once, carried out for two weeks at a pace of two to three times a week.

Interventions/Control_2

Placed in a clean state by neutropenia, a child that can not receive the learning support.

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

6 years-old <=

Age-upper limit

15 years-old >=

Gender

Male and Female

Key inclusion criteria

Located in the neutropenia state, and children who are also calm physical condition.

Key exclusion criteria

Or it has caused the complications, children with problems in the physical condition, such as fever.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yamaguchi Sonoe

Organization

Okayama University

Division name

Graduate School of Health Science

Zip code


Address

2-5-1 Shikata-cho Kita-ku Okayama-shi Okayama-ken Japan

TEL

086-235-8660

Email

sonoeyam@md.okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yamaguchi Sonoe

Organization

Okayama University

Division name

Graduate School of Health Science

Zip code


Address

2-5-1 Shikata-cho Kita-ku Okayama-shi Okayama-ken Japan

TEL

086-235-8660

Homepage URL


Email

sonoeyam@md.okayama-u.ac.jp


Sponsor or person

Institute

Okayama University

Institute

Department

Personal name



Funding Source

Organization

Okayama University

Organization

Division

Category of Funding Organization

Other

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

2016 Year 05 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

Preinitiation

Date of protocol fixation

2016 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 06 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

2016 Year 04 Month 18 Day

Last modified on

2016 Year 04 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025325


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name