UMIN-CTR Clinical Trial

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
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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
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Baseline Characteristics
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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