UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034520 |
|---|---|
| Receipt number | R000038862 |
| Scientific Title | Risk assessment of emotional burden in families of cancer patients:comparison before and after family education and support program |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2018/10/12 13:54:08 |
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Basic information
Public title
Risk assessment of emotional burden in families of cancer patients:comparison before and after family education and support program
Acronym
Risk assessment of emotional burden in families of cancer patients
Scientific Title
Risk assessment of emotional burden in families of cancer patients:comparison before and after family education and support program
Scientific Title:Acronym
Risk assessment of emotional burden in families of cancer patients
Region
| Japan |
Condition
Condition
family caregivers of patients with cancer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
psychological assessment
Basic objectives2
Others
Basic objectives -Others
feasibility of psychological support
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
bereavement risk
Key secondary outcomes
psychological distress
social support
emotional supression
resilience
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
family caregivers of patients with cancer
Doctor's approval
Key exclusion criteria
Other than that.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriaki SATAKE |
Organization
Tohoku University Hospital
Division name
Palliative Care Center
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL
022-717-7768
mercer@xb3.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriaki SATAKE |
Organization
Tohoku University Hospital
Division name
Palliative Care Center
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL
022-717-7768
Homepage URL
mercer@xb3.so-net.ne.jp
Sponsor or person
Institute
Palliative Care Center, Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for Promotion of Science
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prepared
Management information
Registered date
| 2018 | Year | 10 | Month | 16 | Day |
Last modified on
| 2018 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038862
