UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040421
Receipt No. R000046049
Scientific Title Effect of the program before transplant to reduce "Uncertainty before the transplant" for the allogeneic hematopoietic stem cell transplantation patients
Date of disclosure of the study information 2020/07/01
Last modified on 2020/05/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effect of the program before transplant to reduce "Uncertainty before the transplant" for the allogeneic hematopoietic stem cell transplantation patients
Acronym Effect of the program before transplant to reduce "Uncertainty before the transplant" for the allogeneic hematopoietic stem cell transplantation patients
Scientific Title Effect of the program before transplant to reduce "Uncertainty before the transplant" for the allogeneic hematopoietic stem cell transplantation patients
Scientific Title:Acronym Effect of the program before transplant to reduce "Uncertainty before the transplant" for the allogeneic hematopoietic stem cell transplantation patients
Region
Japan

Condition
Condition Allogeneic hematopoietic stem cell transplantation
Classification by specialty
Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study examines the effect of the program to reduce "Uncertainty before the transplant" to the patients undergoing allogeneic hematopoietic stem cell transplantation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Universal Uncertainty in Illness Scale
Key secondary outcomes EORTC-QLQ C30
HADS

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Offer of the brochure before transplant
Record of the everyday life behavior
Telephone support by a nurse every week
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
70 years-old >
Gender Male and Female
Key inclusion criteria hospitalization planned patient for transplant
ECOG Performance Status is 0-1
There are not serious complications, symptom
There is not mental disorder
Key exclusion criteria The patients of the re-transplantation
A name of disease is not announced
ECOG Performance Status at admission more than 2
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Shiro
Middle name
Last name Fujii
Organization Tokushima University Hospital
Division name Department of Hematology
Zip code 770-8503
Address 2-50-1, Kuramoto-cho, Tokushima 770-8503, JAPAN
TEL 0886313111
Email fujii.shiro@tokushima-u.ac.jp

Public contact
Name of contact person
1st name Kimiko
Middle name
Last name Nakano
Organization Tokushima University Hospital
Division name Department of Nursing
Zip code 770-8503
Address 2-50-1, Kuramoto-cho, Tokushima 770-8503, JAPAN
TEL 0886313111
Homepage URL
Email nakano-k@umin.ac.jp

Sponsor
Institute Tokushima University Hospital
Institute
Department

Funding Source
Organization None
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 Tokushima University Hospital
Address 2-50-1, Kuramoto-cho, Tokushima 770-8503, JAPAN
Tel 0886339294
Email awachiken@tokushima-u.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
2020 Year 07 Month 01 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
2020 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 17 Day
Last modified on
2020 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046049

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.