UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037372 |
|---|---|
| Receipt number | R000042549 |
| 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 |
| Date of disclosure of the study information | 2019/07/14 |
| Last modified on | 2022/07/18 07:35:22 |
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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
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
db601007@st.osakafu-u.ac.jp
Sponsor or person
Institute
osaka prefecture University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042549
