UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040421 |
|---|---|
| Receipt number | 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 | 2024/02/02 08:58:37 |
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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
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
nakano-k@umin.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
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
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
https://bct.apbmt.org/articles/bct-2023-013_of/
Publication of results
Published
Result
URL related to results and publications
https://bct.apbmt.org/articles/bct-2023-013_of/
Number of participants that the trial has enrolled
18
Results
Following our intervention, the total UUIS score significantly decreased, from 80.83 before the intervention to 63.06
Results date posted
| 2024 | Year | 02 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The sample included 18 individuals (13 male and five female participants; median age, 52 years).
Most participants had acute lymphoblastic leukemia and had previously undergone bone marrow transplantations.
Participant flow
Twenty-two participants enrolled in the study, but the final sample size was 18. This was because the timing of the intervention was not suitable for three patients, who were suddenly discharged from the hospital and admitted for HSCT without an outpatient visit. One other patient withdrew their consent owing to difficulty completing the study questionnaires
Adverse events
None
Outcome measures
(Universal uncertainty in illness scale; UUIS)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 17 | Day |
Last modified on
| 2024 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046049
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
