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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032947
Receipt No. 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 2019/04/02

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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
Last 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
Email kkamibeppu-tky@umin.ac.jp

Public contact
1st 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
Email shohein-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 32
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
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
2019 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037561

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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