UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014608 |
|---|---|
| Receipt number | R000016996 |
| Scientific Title | Tele-nursing intervention effect with the aim of QOL improvement and exacerbation prevention effect of post-operative complications of prostate cancer patients |
| Date of disclosure of the study information | 2014/07/22 |
| Last modified on | 2014/07/22 11:14:02 |
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Basic information
Public title
Tele-nursing intervention effect with the aim of QOL improvement and exacerbation prevention effect of post-operative complications of prostate cancer patients
Acronym
Tele-nursing intervention effect with the aim of QOL improvement and exacerbation prevention effect of post-operative complications of prostate cancer patients
Scientific Title
Tele-nursing intervention effect with the aim of QOL improvement and exacerbation prevention effect of post-operative complications of prostate cancer patients
Scientific Title:Acronym
Tele-nursing intervention effect with the aim of QOL improvement and exacerbation prevention effect of post-operative complications of prostate cancer patients
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
By comparing the group receiving only routine practice and group support is performed using a tele-nursing for prostate cancer patients of home care in the post-surgery, tele-nursing measures the changes in QOL and post-operative complications to implement the controlled studies on the effect of.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Expanded Prostate Cancer Index Composite
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Using a system developed for the purpose of providing information for reducing complications in the medical live on after surgery for prostate cancer patients. The contents, I will be monitoring in remote areas of the state's day-to-day complications of the subject. To implement questions of medical treatment in live on and provide information about self-care behavior and adjustment of lifestyle to reduce complications, the consultation responses to the problem.
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
| Not applicable |
Age-upper limit
| 70 | years-old | > |
Gender
Male
Key inclusion criteria
Accept it by receiving a description of the survey
Announcement of the disease
· 70 years
By D'Amico classification, Gleason score is classified as either intermediate risk or low-risk, high-risk group of more than 10
Operative therapy
Key exclusion criteria
70 years of age or older
Locally advanced cancer
Classification in ultra high-risk group at NCCN classification
Distant metastasis And mental disorder
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | SATOH DAISUKE |
Organization
Miyagi University
Division name
School of Nursing
Zip code
Address
Kurokawa-gun, Miyagi Prefecture, Taiwa-cho, 1-1 Gakuen
TEL
022-377-8046
satohdai@myu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | SATOH DAISUKE |
Organization
Miyagi University
Division name
School of Nursing
Zip code
Address
Kurokawa-gun, Miyagi Prefecture, Taiwa-cho, 1-1 Gakuen
TEL
0223778046
Homepage URL
satohdai@myu.ac.jp
Sponsor or person
Institute
Miyagi University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 07 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 22 | Day |
Last modified on
| 2014 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016996
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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