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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017498
Receipt No. R000020281
Scientific Title Psychosocial factors associated with distress among cancer survivors after allogeneic hematopoietic stem cell transplantation.
Date of disclosure of the study information 2015/05/11
Last modified on 2020/03/23

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Basic information
Public title Psychosocial factors associated with distress among cancer survivors after allogeneic hematopoietic stem cell transplantation.
Acronym Distress among cancer survivors after allogeneic hematopoietic stem cell transplantation.
Scientific Title Psychosocial factors associated with distress among cancer survivors after allogeneic hematopoietic stem cell transplantation.
Scientific Title:Acronym Distress among cancer survivors after allogeneic hematopoietic stem cell transplantation.
Region
Japan

Condition
Condition Cancer survivors who underwent allogeneic hematopoietic stem cell transplantation.
Classification by specialty
Hematology and clinical oncology Psychiatry
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To identify psychosocial factors associated with distress among cancer survivors after allogeneic hematopoietic stem cell transplantation.
Basic objectives2 Others
Basic objectives -Others Relationship
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Distress measured by the Hospital Anxiety and Depression Scale (HADS).
Key secondary outcomes QOL measured by the MOS 36-Item Short-Form Health Survey (SF-36).

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 1) Patients underwent allogeneic hematopoietic stem cell transplantation on or after January 2010.
2) Patients for whom at least 100 days have passed after allogeneic hematopoietic stem cell transplantation.
3) Patients have received follow-up care after allogeneic hematopoietic stem cell transplant at an outpatient department.
4) Patients achieve clinical remission after the diagnosis of hematological malignancy.
5) Patients who underwent allogeneic hematopoietic stem cell transplantation were age 16 years or more.
6) Patients are age 20 years or more at the time of survey.
Key exclusion criteria 1) Patients are too physically ill as determined by attending physicians.
2) Patients are too psychologically ill as determined by attending physicians.
3) Patients have cognitive impairment.
4) Patients are unable to read or write Japanese.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Shimizu
Organization National Cancer Center Hospital
Division name Department of Psycho-Oncology
Zip code
Address Tukiji 5-1-1, Chuo-ku, Tokyo, Japan.
TEL 03-3542-2511(ext.7004)
Email keshimiz@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hironobu Inoguchi
Organization National Cancer Center Hospital
Division name Department of Psycho-Oncology
Zip code
Address Tukiji 5-1-1, Chuo-ku, Tokyo, Japan.
TEL 03-3542-2511(ext.7351)
Homepage URL
Email hinoguch@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization National Cancer Center
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
Address
Tel
Email

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 北海道大学病院(北海道)
札幌北楡病院(北海道)
仙台医療センター(宮城県)
埼玉医科大学総合医療センター(埼玉県)
千葉大学医学部附属病院(千葉県)
国立がん研究センター中央病院(東京都)
東京大学医科学研究所附属病院(東京都)
東京慈恵会医科大学附属病院(東京都)
神奈川県立がんセンター(神奈川県)
横浜市立大学附属病院(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
岐阜大学医学部附属病院(岐阜県)
名古屋医療センター(愛知県)
京都大学医学部附属病院(京都府)
大阪市立大学医学部附属病院(大阪府)
大阪府立成人病センター(大阪府)
兵庫医科大学病院(兵庫県)
兵庫県立がんセンター(兵庫県)
近畿大学医学部奈良病院(奈良県)
三重大学医学部附属病院(三重県)
島根大学医学部附属病院(島根県)
愛媛県立中央病院(愛媛県)
愛媛大学医学部附属病院(愛媛県)
九州医療センター(福岡県)

Other administrative information
Date of disclosure of the study information
2015 Year 05 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
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
2014 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
2016 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A multicenter cross-sectional study, to identify psychosocial factors associated with distress among cancer survivors after allogeneic hematopoietic stem cell transplantation.

Management information
Registered date
2015 Year 05 Month 11 Day
Last modified on
2020 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020281

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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