UMIN-CTR Clinical Trial

Basic information
Public title	Development and evaluation of nursing proguram that supports self-management in order for patients who developed Chronic graft-versus-host disease to fullfill paychosocial supports needs
Acronym	Development and evaluation of nursing proguram that supports self-management in order for patients who developed Chronic graft-versus-host disease to fullfill paychosocial supports needs
Scientific Title	Development and evaluation of nursing proguram that supports self-management in order for patients who developed Chronic graft-versus-host disease to fullfill paychosocial supports needs
Scientific Title:Acronym	Development and evaluation of nursing proguram that supports self-management in order for patients who developed Chronic graft-versus-host disease to fullfill paychosocial supports needs
Region	Japan

Condition
Condition	after hematopoietic cell transplantation chronic graft-versus-host disease
Classification by specialty	Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	evaluate the effectiveness and the usefulness of the self-management support program for the patient whom chronic GVHD developed in to fuifill psychosocial support needs.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	self management for managing Chornic Diseaase 6item scale and fulfill psychosocial support needs scale
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	A period of the intervention: I evaluate it just after the third intervention before the offer intervention of three times of nursing programs in total once a month three months after intervention
Interventions/Control_2	The group which usually receives care Just after the agreement acquisition, it is evaluated six months after the agreement acquisition two months later by the agreement acquisition
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	When it is GVHD chronic than the chief physician receive explanation continue foreign going to hospital There is not the sign of the recurrence of blood forming organ tumor It is less than three years after hematopoietic cell transplant Chronic GVHD diagnostic criteria disease severity judgment score 1 3 There is a living together family The chief physician and a charge nurse judge study entry to be possible Communication in Japanese is possible understand the purpose of the study, and an agreement is provided for participation
Key exclusion criteria	need hospital care in chronic GVHD diagnostic criteria disease severity judgment score 3 or more The thing which is hospitalized by the recurrence of the underlying disease Dejection and depression targeted for medical treatment and the specialized cognitive-behavioral therapy are diagnosed Mental and physical pain is remarkable, and the participation in nursing program burdens you The thing that communication in Japanese is impossible For study entry of the agreement is not provided
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Yukie Middle name Last name Hosoda
Organization	St Luke's International Hospital
Division name	Nursing department
Zip code	104-8560
Address	9-1,Akashicho,Chuo-ku,Tokyo
TEL	03-3541-2511
Email	y-hosoda@slcn.ac.jp

Public contact
Name of contact person	1st name Yukie Middle name Last name Hosoda
Organization	osaka metropolitan University
Division name	The Graduate School of Nursing
Zip code	583-8555
Address	3-7-30 habikino,habikinocity,osaka
TEL	072-950-2111
Homepage URL
Email	db601007@st.osakafu-u.ac.jp

Sponsor
Institute	osaka prefecture University
Institute
Department

Funding Source
Organization	Incorporated administrative agency Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka metropolitan Univetsity
Address	3-7-30 habikino,habikinocity,osaka
Tel	072-951-2111
Email	db601007@st.osakafu-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	2019 Year 07 Month 14 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	No longer recruiting
Date of protocol fixation	2019 Year 05 Month 20 Day
Date of IRB	2019 Year 02 Month 20 Day
Anticipated trial start date	2019 Year 05 Month 20 Day
Last follow-up date	2022 Year 08 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	2019 Year 07 Month 14 Day
Last modified on	2022 Year 07 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042549