UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032947 |
|---|---|
| Receipt number | R000037561 |
| Scientific Title | Quality of Life and informational needs among patients undergone hematopoietic stem cell transplantation and their caregivers visited long-term follow-up clinic: A multicentered cross-sectional study |
| Date of disclosure of the study information | 2018/06/11 |
| Last modified on | 2022/05/12 13:16:55 |
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Basic information
Public title
Quality of Life and informational needs among patients undergone hematopoietic stem cell transplantation and their caregivers visited long-term follow-up clinic: A multicentered cross-sectional study
Acronym
Quality of Life and informational needs among patients undergone hematopoietic stem cell transplantation and their caregivers visited long-term follow-up clinic
Scientific Title
Quality of Life and informational needs among patients undergone hematopoietic stem cell transplantation and their caregivers visited long-term follow-up clinic: A multicentered cross-sectional study
Scientific Title:Acronym
Quality of Life and informational needs among patients undergone hematopoietic stem cell transplantation and their caregivers visited long-term follow-up clinic
Region
| Japan |
Condition
Condition
Patients who underwent hematopoietic stem cell transplantation
Classification by specialty
| Hematology and clinical oncology | Nursing | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationships between the degrees of fulfillment of informational needs and QOLs among patients and their caregivers
Basic objectives2
Others
Basic objectives -Others
To clarify the content of information regarding HSCT and the degrees of importance and fulfillment of informational needs that patients and their caregivers were required
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(Patients) FACT-BMT
(Caregivers) CQOLC
Key secondary outcomes
(Caregivers) SF-12
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients
1. Patients who underwent hematopoietic stem cell transplantation at 20 years old or older and visited long-term follow-up clinic at least once
2. Patients who agreed to participate in this study
Caregivers
1. Caregivers were defined as family members or friends who would be assuming the primary caregiver role for the patient during transplant periods at 20 years old or older
2. Caregivers who agreed to participate in this study
Key exclusion criteria
Patients
1. Patients who are disqualified by his attending physician or nurses due to his/her physical or mental conditions
2. Patients who were in the hospital or relapsed
Caregivers
1. Caregivers who are disqualified by his attending physician or nurses due to his/her physical or mental conditions
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kamibeppu |
| Middle name | |
| Last name | Kiyoko |
Organization
Division of Health Sciences and Nursing, Graduate School of Medicine, The University of Tokyo
Division name
Department of Family Nursing
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-Ku, Tokyo 113-0033, JAPAN
TEL
03-5841-3556
kkamibeppu-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Nakajima |
| Middle name | |
| Last name | Shohei |
Organization
The University of Tokyo Hospital
Division name
Nursing Department
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-Ku, Tokyo, 113-8655, JAPAN
TEL
03-3815-5411
Homepage URL
shohein-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
YAMAJI FUMIKO NURSING RESEARCH FUND
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-Ku, Tokyo 113-0033, JAPAN
Tel
03-5841-0818
ethics@m.u-tokyo.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
東京大学医学部附属病院（東京都）：The University of Tokyo Hospital (Tokyo)
東京大学医科学研究所附属病院（東京都）：IMSUT Hospital The Institute of Medical Science, The University of Tokyo (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 11 | Day |
Related information
URL releasing protocol
https://bct.apbmt.org/data/bct-2021-005/bct-2021-005_of.pdf
Publication of results
Published
Result
URL related to results and publications
https://bct.apbmt.org/data/bct-2021-005/bct-2021-005_of.pdf
Number of participants that the trial has enrolled
32
Results
A total of 16 patients and 14 caregivers were analyzed. The mean total score of the FACT-BMT was 91.0, and the mean total score of the Caregiver Quality of Life Index-Cancer was 88.2. For both patients and caregivers, fulfillment of informational needs regarding side effects and complications and self-care exerted actor effects on their HRQOL, whereas fulfillment of informational needs regarding psychosocial problems exerted a partner effect on the mutual HRQOL.
Results date posted
| 2022 | Year | 05 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 03 | Month | 25 | Day |
Baseline Characteristics
refer to the paper
Participant flow
refer to the paper
Adverse events
Not in particular.
Outcome measures
(Patients) FACT-BMT
(Caregivers) CQOLC
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
This survey is a cross-sectional observational study. Patients who visited c research collaboration institutes during the registration period and their caregivers are the participants for this study.
Management information
Registered date
| 2018 | Year | 06 | Month | 11 | Day |
Last modified on
| 2022 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037561
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| Registered date | File name |
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