UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038811
Receipt number R000044028
Scientific Title Evaluation of the practical status of discharge plannning assessment sheets for patient with hematopoietic stem cell transplantation
Date of disclosure of the study information 2019/12/06
Last modified on 2019/12/06 16:17:38

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Basic information

Public title

Evaluation of the practical status of discharge plannning assessment sheets for patient with hematopoietic stem cell transplantation

Acronym

Evaluation of the practical status of discharge plannning assessment sheets for patient with hematopoietic stem cell transplantation

Scientific Title

Evaluation of the practical status of discharge plannning assessment sheets for patient with hematopoietic stem cell transplantation

Scientific Title:Acronym

Evaluation of the practical status of discharge plannning assessment sheets for patient with hematopoietic stem cell transplantation

Region

Japan


Condition

Condition

Patient with hematopoietic stem cell transplantation

Classification by specialty

Hematology and clinical oncology Nursing

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We evaluate the practical status of discharge plannning assessment sheets for patient with hematopoietic stem cell transplantation

Basic objectives2

Others

Basic objectives -Others

Nothing

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Using the assessment sheet, responding to the IPOS patient answer to the question about "Did you feel like you were dealing your concern?" and evaluating the practice of the assessment sheet by the interviewed nurses.

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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

(1)Patient with first line of HSCT
(2)Concent can be obtained

Key exclusion criteria

Patient with Auto PBSCH

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Takahashi
Middle name
Last name Mizuho

Organization

Tohoku University Hospital

Division name

Department of Nursing

Zip code

980-8574

Address

miyagiken sendaisi aobaku seiryochou 1-1

TEL

022-717-7000

Email

miryong.lee@med.tohoku.ac.jp


Public contact

Name of contact person

1st name Takahashi
Middle name
Last name Mizuho

Organization

Tohoku University Hospital

Division name

Department of nursing

Zip code

980-8574

Address

Miyagiken sendaisi aobaku seiryochou 1-1

TEL

022-717-7000

Homepage URL


Email

miryong.lee@med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University Hospital

Institute

Department

Personal name



Funding Source

Organization

Tohoku University Hospital

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

Tohoku University Hospital Clinical Research Ethics Committee

Address

miyagiken sendaisi aobaku seiryocho1no1

Tel

022-717-7000

Email

miryong.lee@med.tohoku.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

2019 Year 12 Month 06 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

2019 Year 11 Month 10 Day

Date of IRB


Anticipated trial start date

2019 Year 12 Month 01 Day

Last follow-up date

2024 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observational study by interview and using assessment sheets.


Management information

Registered date

2019 Year 12 Month 06 Day

Last modified on

2019 Year 12 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044028


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name