UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017498 |
|---|---|
| Receipt number | 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 10:09:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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)
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
hinoguch@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020281
