UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035023 |
|---|---|
| Receipt number | R000039218 |
| Scientific Title | Prospective study of correlation between pain and anxiety after radiotherapy |
| Date of disclosure of the study information | 2018/11/27 |
| Last modified on | 2021/10/28 14:05:27 |
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Basic information
Public title
Prospective study of correlation between pain and anxiety after radiotherapy
Acronym
Correlation of Palliative radiotherapy for bone metastasis and anxiety.
Scientific Title
Prospective study of correlation between pain and anxiety after radiotherapy
Scientific Title:Acronym
Correlation of Palliative radiotherapy for bone metastasis and anxiety.
Region
| Japan |
Condition
Condition
Bone metastasis
Classification by specialty
| Radiology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the correlation between efficacy of pain reduction and anxiety reduction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of pain and anxiety between before and after palliative Radiotherapy
Key secondary outcomes
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients with painful bone metastasis refferd to radiotherapy department
Key exclusion criteria
Tha patients without bone metastasis
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Tanaka |
Organization
Asahi University Hospital
Division name
Dept. of Radiation Oncology
Zip code
Address
3-23 Hashimoto-cho gifu gifu Japan
TEL
0582538001
c.bluered@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuka Kunishima |
Organization
Asahi University Hospital
Division name
Dept. of Radiation Oncology
Zip code
Address
3-23 Hashimoto-cho gifu gifu Japan
TEL
0582538001
Homepage URL
kuni92.0805@gmail.com
Sponsor or person
Institute
Asahi University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
朝日大学病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2018 | Year | 11 | Month | 27 | Day |
Last modified on
| 2021 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039218
