UMIN-CTR Clinical Trial

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
Institute	Tohoku University Hospital
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044028